Clinical Research in the Heart and Vascular Institute

COMPETENCE

Principal investigator: Behzad Soleimani, MD (Research profile | Find a Doctor profile)

Purpose: To evaluate the safety and performance of the EVAHEART 2 LVAS (Left Ventricular Assist System) in patients with advanced heart failure whom require implantation of a durable Left Ventricular Assist Device.

Major inclusion criteria:

• Left ventricle ejection fraction less than 30%

• Inotrope Dependent or having severe HF (Heart Failure) in which one is dependent upon an IABP (Intra-Aortic Balloon Pump) for at least seven days, or an Impella heart pump device for at least three days. The IABP and Impella devices are temporary mechanical heart assist devices that help the heart to pump more blood.

• NYHA class III with dyspnea (difficult or labored breathing) upon mild physical activity or NYHA Class IV

Major exclusion criteria:

• Planned BiVad support

• Platelet count less than 100,000

• History of any organ transplant

Learn more: View this trial on clinicaltrials.gov.

Guardian Registry

Principal investigator: Balakrishnan Mahesh, MD (Research profile | Find a Doctor profile)

Purpose: Post market, observational registry of adult and pediatric heart transplant recipient patients whose donor heart was preserved and transported with SherpaPak Cardiac Transport System.

Major inclusion criteria:

• Donor and donor hearts matched to the prospective recipient based upon institutional medical practice

• Recipient: registered male or female primary heart transplant candidates

Major exclusion criteria:

• Donor and donor hearts that do not meet institutional clinical requirements for transplantation

• Recipient: when safe connection with aorta cannot be made. Patients who are incarcerated or have had a previous transplant.

Learn more: View this trial on clinicaltrials.gov.

LAAOS-4

Principal Investigator: Soraya Samii, MD (Research profile | Find a Doctor profile)

Purpose: To determine if catheter-based endovascular left atrial appendage occlusion (LAAO) prevents ischemic stroke or systemic embolism in participants with atrial fibrillation (AF), who remain at high risk of stroke, despite receiving ongoing treatment with oral anticoagulation. Principal Investigator: Soraya Samii, MD (Research profile | Find a Doctor profile)

Major inclusion criteria:

• (a) Persistent or permanent atrial fibrillation OR (b) Paroxysmal atrial fibrillation in participants with a history of ischemic stroke or systemic embolism

• CHA2DS2-VASc stroke risk score of ≥ 4

• Treatment with oral anticoagulants (Vitamin K agonist or factor Xa inhibitor) for at least 90 days prior to enrollment, AND no documented plan to discontinue treatment with oral anticoagulants for the expected duration of the trial.

Major exclusion criteria:

• Current left atrial appendage thrombus

• Prior left atrial appendage occlusion or removal (surgical or percutaneous)

• Prior percutaneous atrial septal defect or patent foramen ovale closure

• Prior atrial fibrillation ablation unless evidence of recurrent qualifying atrial fibrillation present at least 30 days following ablation

• Planned atrial fibrillation ablation within 90 days of enrollment

• Individuals being treated with direct thrombin inhibitors

Learn more: View this trial at clinicaltrials.gov.

WiSE-UP Registry

Principal Investigator: Soraya Samii, MD (Research profile | Find a Doctor profile)

Purpose: The purpose of the WiSE-UP Registry is to collect real-world, observations to understand acute and long-term product performance, including patient safety, clinical outcomes, and CRT response associated with the use of the market-released WiSE System.

Major inclusion criteria:

• Patient intends to receive a WiSE System and has passed the acoustic window screening

• Patient who will be accessible for follow-up.

• Patient is not enrolled in a concurrent drug and/or device study that may confound the Registry results

Major exclusion criteria:

• No exclusion criteria

Learn more: View this trial at clinicaltrials.gov.

Dal-GenE-2

Principal investigator: Michael Farbaniec, MD (Research profile | Find a Doctor profile)

Purpose: Research has consistently shown that a decrease in HDL-C levels are associated with an increased risk of developing coronary heart disease. Dalcetrapib is a compound that increases levels of HDL-C through modulation of plasma CETP activity. The primary objective of this trial is to evaluate the potential of dalcetrapib to safely reduce the incidence of fatal and non-fatal myocardial infarction in patients with documented recent acute coronary syndrome and the AA genotype.

Major inclusion criteria:

• Recently hospitalized for ACS defined – defined as either spontaneous myocardial infarction, procedure-related myocardial infarction after PCI, or ECG abnormalities without biomarkers.

• Individuals ages 45+ with AA genotype at variant rs 1967309 in the ADCY9 gene

• Free of ischemic symptoms at rest or with minimal exertion for at least 1 week

Major exclusion criteria:

• Females who are pregnant, breast-feeding, or of childbearing potential without contraception use.

• NYHA Class III – IV heart failure, index ACS event due to uncontrolled hypertension, or have undergone CABG between index and randomization

• Systolic BP >180 and/or diastolic BP >110 mmHg, ALT or AST >3x ULN, phosphokinase levels >5 times the ULN, eGFR <30 mL/min/1.73m²

• liver disease, active hepatitis, history of malignancy, or other significant comorbidities

Learn more: View this trial at clinicaltrials.gov.

SELUTION 4 DeNovo

Principal investigator: Aaron Lee, MD (Research profile | Find a Doctor profile)

Purpose: Evaluate efficacy and safety of the SELUTION SLR 014 PTCA Drug Eluting Balloons for the treatment of patients with DeNovo coronary small vessel lesions.

Major inclusion criteria:

• Subject presents with chronic coronary syndromes (CSS), unstable angina, or stabilized non-ST elevation myocardial infarction (NSTEMI) with an indication for PCI and planned intervention.

• Subject can tolerate dual antiplatelet therapy with aspirin, plus either Clopidogrel, Prasugrel or Ticagrelor.

• Subject has life expectancy of greater than 1 year in the opinion of the investigator.

Major exclusion criteria:

• Subject with known hypersensitivity or allergy to Sirolimus or other pharmacologic agents required for the procedure.

• Subject presents with NSTEMI and rising biomarkers, ongoing chest pain, or is hemodynamically instable.

• Subject with history of ST-elevation myocardial infarction (STEMI) within 30 days of the index procedure or history of New York Heart Association NYHA class III or IV heart failure.

• Subject with planned major surgery, planned treatment of lesion involving aorto-ostial location or planned PCI of a non-target vessel within 30 days following the index procedure.

Learn more: View this trial at clinicaltrials.gov.

SOS-AMI

Principal investigator: Michael Farbaniec, MD (Research profile | Find a Doctor profile)

Purpose: To evaluate the efficacy and safety of self-administered subQ (subcutaneous) selatogrel for prevention of all-cause death and treatment of acute MI (Myocardial Infarction) in subjects with recent history of acute MI (Myocardial Infarction). Selotogrel is a P2Y12 receptor antagonist which provides prompt and potent platelet inhibition.

Major inclusion criteria:

• Individual whom has had an MI (Myocardial Infarction) within the past 4 weeks

• Presence of either a second MI (Myocardial Infarction) within one year or having at least one of the following risk factors: DM (Diabetes Mellitus), CKD (Chronic Kidney Disease), multivessel CAD (Coronary Artery Disease), PAD (Peripheral Arterial Disease), 65 years old or older, or being an active daily smoker

• Discharged with confirmed type 1 AMI (Acute Myocardial Infarction)

Major exclusion criteria:

• Chronic anemia with hemoglobin less than 10

• Increased risk of serious bleeding such as having a history of GI (Gastrointestinal) bleed, triple antithrombotic, intracranial bleed

• Platelet count less than 100,000

Learn more: View this trial on clinicaltrials.gov.

STRIKE-PE

Principal investigator: Chad Zack, MD (Research profile | Find a Doctor profile)

Purpose: A Prospective, Multicenter Study of the IndigoTM Aspiration System Seeking to Evaluate the Long-Term Safety and Outcomes of Treating Pulmonary Embolism

Major inclusion criteria:

• Acute signs or symptoms of a PE ≤ 14d

• RV/LV ratio ≥ 0.9 via CTA or ECHO

Major exclusion criteria:

• Contraindication of anticoagulants

• Stage IV cancer

• Currently on ECMO

Learn more: View this trial on clinicaltrials.gov.

AIM-Higher

Principal investigator: John Boehmer, MD (Research profile | Find a Doctor profile)

Purpose: To evaluate the safety and efficacy of cardiac contractility modulation therapy (CCM) in patients with symptomatic heart failure with left ventricle ejection fraction between 40 and 60%.

Major inclusion criteria:

• Diagnosed with symptomatic heart failure

• Left ventricle ejection fraction greater than or equal to 40 and less than or equal to 60%

• Heart failure hospitalization within 12 months prior to study consent OR urgent heart failure visit requiring IV therapy during the six months prior to study consent, AND elevated BMI-adjusted natriuretic peptide values OR if there is no heart failure hospitalization within 12 months prior to study consent OR an urgent heart failure visit requiring IV therapy within six months prior to study consent, must have an elevated BMI-adjusted natriuretic peptide value

• Subjects must be on stable, scheduled, oral loop diuretic treatment for at least 30 days prior to study consent

Major exclusion criteria:

• Receiving cardiac resynchronization therapy (CRT)

• Exercise tolerance limited by a condition other than heart failure

• Dialysis (permanent) or GFR less than 20 ml/min/1.73m2

Learn more: View this trial on clinicaltrials.gov.

BalanceD-HF

Principal Investigator: Umar Farooq, MD (Research profile | Find a Doctor profile)

Purpose: Study the efficacy of the usage of mineralocorticoid receptor antagonists (MRA) and Sodium/glucose cotransporter 2 (SGLT2) in the treatment of subjects with heart failure in combination with impaired kidney function.

Major inclusion criteria:

• Age ≥ 18 years

• Documented diagnosis of symptomatic heart failure (HF) – NYHA functional class II-IV

• Having had a recent HF event within 6 months (hospitalization or urgent visit)

• Have a left ventricular ejection fraction (LVEF) value from an assessment within the last 12 months

• Managed with standard of care (SoC) therapy for HF and renal impairment according to local guidelines

• NT-proBNP must be >300 pg/mL (>600 pg/mL if concomitant atrial fibrillation or atrial flutter)

• Not taking a mineralocorticoid receptor antagonist

• An eGFR ≥ 20 to < 60 mL/min/1.73 m2

• Serum/plasma potassium ≥ 3.5 mmol/L and ≤ 5.0 mmol/L

Major exclusion criteria:

• Acute coronary syndrome (unstable angina or myocardial infarction), stroke or transient ischemic attack within the previous 3 months

• Major cardiac surgery, coronary revascularization or valvular repair or replacement, or implantation of a Cardiac resynchronization therapy device within 3 months prior to enrolment or planned to undergo any of these operations

• History of hypertrophic obstructive cardiomyopathy

• Complex congenital heart disease or severe uncorrected primary valvular disease

• Symptomatic bradycardia or second- or third-degree heart block without a pacemaker

• Systolic BP < 100 mmHg, or symptomatic hypotension within the past 24 hours

• Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD or exacerbation of COPD requiring invasive mechanical ventilation assistance within 12 months prior to enrolment

• Type 1 diabetes mellitus

• Kidney replacement therapy in the past 4 weeks, currently requiring kidney replacement or imminent plan to start kidney replacement therapy

• Hepatic disease, including active HBV or HCV infection, or other cause of hepatitis, and/or hepatic impairment

• Suspected or confirmed COVID-19 infection within the last 4 weeks or hospitalization for COVID-19 within the last 12 weeks

• Treatment with strong or moderate CYP3A4 inhibitor or inducer

The Inclusion and Exclusion Criteria provided here is representative, and not complete.

Learn more: View this trial at clinicaltrials.gov.

COMET-HF

Principal investigator: John Boehmer, MD (Research profile | Find a Doctor profile)

Purpose: To evaluate the efficacy of the investigational drug, omecamtiv mecarbil, compared with placebo on the risk of HF outcomes (i.e. hospitalizations, transplantations, or deaths) in patients with symptomatic HFrEF and severely reduced ejection fraction in the setting of guideline-directed medical therapy.

Major inclusion criteria:

• Chronic and severe HFrEF w EF <30%

• NTproBNP ≥ 1000

• A-fib patients must have NTproBNP ≥ 3000 and EF <25%.

Major exclusion criteria:

• Taking or plan to take Digoxin

• eGFR <20

• ACS or cardiac procedure within 3 months of screening

Learn more: View this trial on clinicaltrials.gov.

PROACTIVE-HF-2

Principal investigator: John Boehmer, MD (Research profile | Find a Doctor profile)

Purpose: The Cordella PA Sensor System, in conjunction with Cordella Heart Failure System, will be used to measure, record, and transmit pulmonary artery pressure data from NYHA Class II-III heart failure patients at home to clinicians for assessment. The overall purpose of this study is to reduce heart failure hospitalizations by enabling clinical decision making and clinician-directed self-management prior to the development of symptoms.

Major Inclusion Criteria

• Individuals age 18+ with diagnosis and treatment of heart failure for ≥ 3 months and NYHA Class II HF (randomized arm) or NYHA III (single arm) at screening

• Standard of care HF therapy for at least 30 days prior to screening/enrollment visit

• HF related hospitalization or urgent HF visit within 6 months (randomized arm) or 12 months (single arm)

• Diuretic therapy for ≥ 1 month (≥ 40mg furosemide or equivalent)

Major Exclusion Criteria

• ACC/AHA Stage D refractory HF and known history of >24 hours of IV inotropic therapy to support circulation within the past 6 months

• History of recurrent pulmonary embolism (≥ 2 episodes within 5 years) and/or deep vein thrombosis in the femoral or IJ vein used for access

• Resting systolic BP >90 mmHg and/or severe pre-capillary pulmonary hypertension (pulmonary artery systolic pressure (≥ 70mmHg and with pulmonary capillary wedge pressure ≤ 15 mmHg at the Cordella PA Sensor Implant RHC

• Major CV event within 3 months of screening, unrepaired severe valvular disease, unrepaired congenital heart disease that has not been repaired and would prevent implantation, coagulation disorders, allergy to platelet aggregation inhibitors, allergy to contrast dye, active infection, or likely to receive advanced therapy in the next 24 hours

• GFR <20 ml/min or chronic renal dialysis

• Implanted with CRT-P or CRT-D or underwent mitral/tricuspid valve repair/replacement within 90 days or catheter ablation for A Fib within 30 days prior to screening visit

Learn more: View this trial at clinicaltrials.gov.

REBIRTH

Principal investigator: John Boehmer, MD (Research profile | Find a Doctor profile)

Purpose: To look at the use of bromocriptine and its impact on myocardial recovery in newly diagnosed peripartum cardiomyopathy within five months postpartum

Major inclusion criteria:

• New diagnosis of cardiomyopathy within five months

• Left ventricle ejection fraction less than or equal to 40%

Major exclusion criteria:

• Previous diagnosis of cardiomyopathy, valvular disease or complex congenital disease

• Currently pregnant

• Cannot be actively breastfeeding for randomized cohort, but women who meet eligibility criteria and wish to breastfeed will be eligible for participation in an observational cohort.

Learn more: View this trial on clinicaltrials.gov.

TEAM-HF

Principal investigator: John Boehmer, MD (Research profile | Find a Doctor profile)

Purpose: The purpose of the clinical trial is to evaluate the safety and effectiveness of mechanical circulatory support in patients with advancing heart failure. TEAM-HF Randomized Arm: The objective of the randomized Arm is to 1) demonstrate improvement in survival when non-inotrope dependent advanced HF patients are treated with the HeartMate 3™ left ventricular assist system (LVAS) compared to being managed on medical therapy alone and 2) to establish disease-state criteria to trigger referral for a HeartMate 3 LVAS. TEAM-HF Single Arm Registry objective is to examine, in patients with lower PAP, the impact of delayed HM3 LVAS implantation on survival and adverse events.

Major inclusion criteria:

• NYHA class IIIB or IV

• LVEF ≤ 30% and CI < 2.2L/min/m2

• Planned referral to the VAD team for evaluation or current VAD workup in progress

• Consistent ability to record and send readings with CardioMEMS

Major exclusion criteria:

• Has any of the following: previous solid organ transplant, mechanical aortic valve that will not be converted to a bio-prosthesis or over sewn at time of LVAD implant, complex congenital heart disease, eGFR < 30 or on chronic dialysis, or history of recurrent PE’s/DVTs

Learn More: View this trial at clinicaltrials.gov.

CorCinch-HF 5019

Principal investigator: John Boehmer, MD (Research profile | Find a Doctor profile)

Purpose: To evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with heart failure with reduced ejection fraction (HFrEF)

Major inclusion criteria:

• Left ventricle ejection fraction (LVEF) ≥20% and ≤40%

• NYHA Class III, Ambulatory Class IV or Class II with a heart failure hospitalization within the past 12 months

Major exclusion criteria:

• Diagnosed with heart failure other than ischemic and non-ischemic (i.e. hypertrophic, amyloid, restrictive etc.)

• Moderate to severe valvular abnormalities

• Renal insufficiency with estimated Glomerular Filtration Rate (eGFR), which is a measurement of how much blood the kidneys filter each minute < 25

Learn more: View this trial on clinicaltrials.gov.

CLASP II TR

Principal Investigator: Mark Kozak, MD.

Purpose: The primary objective is to evaluate the safety and effectiveness of the PASCAL System for transcatheter tricuspid valve repair with optimal medical therapy (OMT) compared to OMT alone in the treatment of patients with symptomatic severe tricuspid regurgitation.

RELIVE

Principal investigator: Michael Pfeiffer, MD (Research profile | Find a Doctor profile)

Purpose: The purpose of the study is to assess the safety and effectiveness of the BioVentrix Revivent System plus GDMT compared to GDMT alone for the treatment of LV anterior/apical scar/aneurysm with possible additional involvement of the lateral, septal, and/or inferior regions in patients with symptomatic heart failure.

Major inclusion criteria:

• Presence of LV Aneurysm or Scar as evidenced by a contiguous a contractile (akinetic and/or dyskinetic) non-calcified scar

• Presence of LV Aneurysm/Scar involving anterior, apical, or anterolateral ± septal regions of the left ventricle

• Left Ventricular Ejection Fraction ≤ 40%

• Heart failure symptoms as defined by NYHA Classification > 2

• Patient is on adequate and stable Guideline Directed Medical Therapy (GDMT) for at least 3 months

Major exclusion criteria:

• Peak Systolic Pulmonary Arterial Pressure > 70 mm Hg via echo or right heart catheterization

• Chronic renal failure with a eGFR<30ml/min

• Thrombus or intra-ventricular mass in the left ventricle as verified by cardiac imaging

Learn more: View this trial on clinicaltrials.gov.

HERCULES

Principal investigator: Faisal Aziz, MD (Research profile | Find a Doctor profile)

Purpose: To evaluate the outcomes of two surgical approaches for wide neck infrarenal aortic aneurysms. The two surgeries that will be compared are the Heli-FX EndoAnchor system (ESAR) and the Endurant II/IIs stent grafts without endoanchors (EVAR).

Major inclusion criteria:

• Elective AAA repair scheduled according to current guidelines

• Eligible anatomy for treatment with the Endurant II/IIs endograft (EVAR) and Heli-FX EndoAnchor (ESAR) systems

Major exclusion criteria:

• Patient is not eligible for the standard Endurant II/IIs endograft (EVAR) and Heli-FX EndoAnchor (ESAR) systems

• Patient has previously been treated with an aortic stent

Learn more: View this trial on clinicaltrials.gov.

Intervascular Grafts and Patches Registry

Principal investigator: Faisal Aziz, MD (Research profile | Find a Doctor profile)

Purpose: Post market clinical follow-up registry to evaluate the long-term safety & performance of Intervascular Vascular Grafts & Patches for bypass, repair, or replacement of aortic, peripheral, or carotid arteries. Retrospective Data Collection Only.

Major inclusion criteria:

• Patients that have undergone bypass, replacement, or repair of the peripheral arteries, aorta, or carotid artery using the Intervascular Vascular Grafts & Patches between 2011 & 2021

Major exclusion criteria:

• Active infection in region of device placement at time of implantation of the graft or patch

Learn more: View this trial on clinicaltrials.gov.

Electrophysiology

• BIO-LivIQ

  • Principal investigator: Sarah Hussain, MD (Research profile | Find a Doctor profile)

  • Purpose: Confirm the safety & performance of the LivIQ right ventricular leadless pacemaker system in patients with Class I or II indication for ventricular pacing (VVI/VDD).

  • Learn more: View this trial on clinicaltrials.gov.

• SEAFRONT

  • Principal investigator: Soraya Samii, MD (Research profile | Find a Doctor profile)

  • Purpose: To evaluate blood coagulability and coagulation markers at baseline and throughout two years of follow-up in patients with first-diagnosed non-valvular atrial fibrillation/flutter (AF), prevalent non-valvular AF, or arterial disease. The secondary objectives are to observe the characteristics, comorbidities, treatment patterns, clinical outcome rates, and reasons for non-treatment of these patients in modern clinical practice.

General/Interventional Cardiology

• Corrie Lipids Program

  • Principal investigator: Michael Farbaniec, MD (Research profile | Find a Doctor profile)

  • Purpose: The purpose of this research is to incorporate a digital health application into patient's routine care, encouraging a more active role in their health care. The research aims to show evidence that enrollment into the lipid program will result in improved LDL-C (Low-Density Lipoprotein Cholesterol) goal attainment for patients.

• EMPA-HEART 3

  • Principal investigator: Elisa Bradley, MD (Research profile | Find a Doctor profile)

  • Purpose: The purpose of this research is to evaluate participant-reported outcome measures in adults with Fontan Circulatory Failure randomized to either 12 weeks of therapy with the SGLT2 inhibitor, empagliflozin, or placebo.

Heart Failure and Heart Transplant

• CLEOPATTRA

  • Principal investigator: John Boehmer, MD (Research profile | Find a Doctor profile)

  • Purpose: To demonstrate superiority of coramitug (NNC6019-001) 4800 mg versus placebo (randomized 1:1), when added to standard of care in reducing cardiovascular death and morbidity in participants with variant or wild-type transthyretin (TTR) amyloid cardiomyopathy (ATTRv-CM or ATTRwt-CM, respectively).

  • Learn more: View this trial on clinicaltrials.gov.

• RECOVER-HF

  • Principal investigator: John Boehmer, MD (Research profile | Find a Doctor profile)

  • Purpose: Prove that the VisONE Implantable Diaphragmatic Stimulation System, along with medication therapy, improves quality of life, and exercise ability in patients with heart failure with reduced ejection fraction better than medication therapy alone.

  • Learn more: View this trial on clinicaltrials.gov.

Structural Heart Disease

No upcoming structure heart disease studies.

Vascular Disease

• US ERI Abdominal Study

  • Principal Investigator: Faisal Aziz, MD (Research profile | Find a Doctor profile)

  • Purpose: To evaluate the accuracy of a new predictive model algorithm for predicting the risk of certain types of endoleaks peri-operatively and post-procedural for an endovascular abdominal aneurysm repair with and without endoanchors.

Principal Investigator: Andrew R Waxler, MD (Find a Doctor profile)

Purpose: Research has consistently shown that a decrease in HDL-C levels are associated with an increased risk of developing coronary heart disease. Dalcetrapib is a compound that increases levels of HDL-C through modulation of plasma CETP activity. The primary objective of this trial is to evaluate the potential of Dalcetrapib to safely reduce the incidence of fatal and non-fatal myocardial infarction in patients with documented hospitalization within the past 3 months for Acute Coronary Syndrome and the AA genotype.

Major inclusion criteria:

• Recently hospitalized within the past 3 months for ACS (Acute Coronary Syndrome) ACS is defined as either spontaneous myocardial infarction, procedure-related myocardial infarction after PCI, or certain ECG abnormalities without biomarkers.

• Individuals ages 45+ with AA genotype at variant rs 1967309 in the ADCY9 gene

• Free of ischemic symptoms at rest or with minimal exertion for at least 1 week

Major exclusion criteria:

• Females who are pregnant, breast-feeding, or of childbearing potential without contraception use.

• NYHA Class III – IV heart failure, index ACS event due to uncontrolled hypertension, or have undergone CABG between index and randomization

• Systolic BP >180 and/or diastolic BP >110 mmHg, ALT or AST >3x ULN, phosphokinase levels >5 times the ULN, eGFR <30 mL/min/1.73m2

• Liver disease, active hepatitis, history of malignancy, or other significant comorbidities

Learn more: View this trial on clinicaltrials.gov.

Principal investigator: Ronald J. Polinsky, MD (View Find a Doctor profile)

Contact: Emese Futchko, RN, MSN, CCRC – 610-685-8500, ext. 271; or efutchko@pennstatehealth.psu.edu

Purpose: To assess whether AFSW (Atrial fibrillation sensing smart watch)-guided, time-delimited DOAC (direct continuous oral anticoagulation) therapy is non-inferior to continuous DOAC therapy for a composite endpoint that includes: (1) Ischemic stroke; (2) Systemic embolism; (3) All-cause mortality.

Major Inclusion Criteria:

• 22-85 years of age.

• English-speaking participants

• Documented history of symptomatic or asymptomatic paroxysmal or persistent AF. The duration of AF must have been > 30 seconds as documented by an external monitor or present on 12-lead ECG.

• CHA2DS2-VASC score of 1-4 without prior stroke or TIA**

• The participant is on a DOAC at the time of screening.

• Willing and able to comply with the protocol, including:

  • Possession of a smartwatch-compatible smartphone (iPhone that supports the latest shipping iOS) with a cellular service plan

  • Be willing to wear the smartwatch for the suggested minimum of 14 hours a day

  • Expected to be within cellular service range at least 80% of the time

• Willing and able to discontinue DOAC

Major exclusion criteria:

• Valvular or permanent atrial fibrillation.

• Current treatment with warfarin and unwilling or unable to take a DOAC.

• The participant is a woman who is pregnant, nursing, or of child-bearing potential and is not on birth control.

• The participant is being treated with chronic aspirin, another anti-platelet agent, or chronic NSAIDS outside of current medical guidelines (e.g., primary stroke prevention in patients with atrial fibrillation, primary prevention of cardiovascular events, pain relief, fever, gout) and is unwilling or unable to discontinue use for the study duration.

• Existing cardiac rhythm device or indication for a permanent pacemaker, ICD or CRT device or planned insertable cardiac monitor.

• Any documented single AF episode lasting ≥ 1 hour on screening external cardiac monitor of > 6 days duration.

• Mechanical prosthetic valve(s) or severe valve disease.

• Hypertrophic cardiomyopathy.

• Participant needs DOAC for reasons other than preventing stroke or arterial embolism resulting from AF (i.e., preventing DVT or PE) or needs permanent OAC (i.e., congenital heart defects, prosthetic heart valve).

• Participants deemed high risk for non-cardioembolic stroke (i.e., significant carotid artery disease defined as stenosis > 75%) based on the investigator’s discretion.

• The participant is enrolled, has participated within the last 30 days, or is planning to participate in a concurrent drug and/or device study during the course of this clinical trial. Co-enrollment in concurrent trials is only allowed with documented pre-approval from the study manager; there is no concern that co-enrollment could confound the results of this trial.

• The participant has a tattoo, birthmark, or surgical scar over the dorsal wrist area on the ipsilateral side that the AFSW may be worn.

• The participant has a tremor on their ipsilateral side that the AFSW may be worn.

• Any concomitant condition that, in the investigator’s opinion, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse).

• Known hypersensitivity or contraindication to direct oral anticoagulants.

• Documented prior stroke (ischemic or hemorrhagic) or transient ischemic attack.

• Reversible causes of AF (e.g., cardiac surgery, pulmonary embolism, untreated hyperthyroidism). AF ablation does not constitute reversible AF.

• > 5% burden premature atrial or ventricular depolarizations on any given calendar day on pre-enrollment cardiac monitoring.

• History of atrial flutter that has not been treated with ablation (participants in atrial flutter and have been ablated are eligible for enrollment).

• Stage 4 or 5 chronic kidney disease.

• Conditions associated with an increased risk of bleeding:

  • Major surgery in the previous month

  • Planned surgery or intervention in the next three months.

  • History of intracranial, intraocular, spinal, retroperitoneal, or atraumatic intraarticular bleeding

  • Gastrointestinal hemorrhage within the past year unless the cause has been permanently eliminated (e.g., by surgery)

  • Symptomatic or endoscopically documented gastroduodenal ulcer disease in the previous 30 days

  • Hemorrhagic disorder or bleeding diathesis

  • Need for anticoagulant treatment for disorders other than AF

  • Required use of non-aspirin antiplatelet agents (i.e., Plavix) at time of enrollment

  • Uncontrolled hypertension (SBP >180 mmHg and/or DBP >100 mmHg

Principal investigator: Aaron Lee, MD (Research profile | Find a Doctor profile)

Contact: Emese Futchko, RN, MSN, CCRC – 610-685-8500, ext. 271 or efutchko@pennstatehealth.psu.edu

Local investigator at Berks Cardiology: Troy Trayer, MD (Find a Doctor profile)

Purpose: Evaluate efficacy and safety of the SELUTION SLR 014 PTCA Drug Eluting Balloons for the treatment of patients with DeNovo coronary small vessel lesions.

Major inclusion criteria:

• Subject presents with chronic coronary syndromes (CSS), unstable angina, or stabilized non-ST elevation myocardial infarction (NSTEMI) with an indication for PCI and planned intervention.

• Subject can tolerate dual antiplatelet therapy with aspirin, plus either Clopidogrel, Prasugrel or Ticagrelor.

• Subject has life expectancy of greater than 1 year in the opinion of the investigator.

Major exclusion criteria:

• Subject with known hypersensitivity or allergy to Sirolimus or other pharmacologic agents required for the procedure.

• Subject presents with NSTEMI and rising biomarkers, ongoing chest pain, or is hemodynamically instable.

• Subject with history of ST-elevation myocardial infarction (STEMI) within 30 days of the index procedure or history of New York Heart Association NYHA class III or IV heart failure.

• Subject with planned major surgery, planned treatment of lesion involving aorto-ostial location or planned PCI of a non-target vessel within 30 days following the index procedure.

Learn more: View this trial at clinicaltrials.gov.

Principal investigator: Ronald J. Polinsky Jr., MD (View Find a Doctor profile)

Contact: Emese Futchko, RN, MSN, CCRC – 610-685-8500, ext. 271 or efutchko@pennstatehealth.psu.edu

Purpose: The primary objective of the study is to assess the clinical efficacy of selatogrel when self-administered upon occurrence of symptoms suggestive of an acute myocardial infarction (AMI) in subjects at risk of having a recurrent AMI (acute myocardial infarction).

Major inclusion criteria:

• Confirmed diagnosis of symptomatic type 1 AMI [STEMI (ST-elevation myocardial infaction)or NSTEMI (non-ST elevation myocardial infaction)], no longer than four weeks prior to randomization.

• Diagnosis of multivessel coronary artery disease defined as greater than or equal to 50% stenosis on two or more coronary artery territories or on the left main artery during a prior cardiac catheterization or cardiac catheterization during the qualifying AMI event and presence of at least two of the following risk factors:

  • Second prior AMI

  • Diabetes mellitus defined by ongoing glucose lowering treatment

  • Chronic kidney disease with estimated glomerular filtration rate less than 60 mL/min/1.73 m2

  • PAD (peripheral arterial disease) defined as any of the following at any time prior to randomization:

    • Ankle/brachial index less than 0.85

    • Amputation, peripheral bypass, or peripheral angioplasty of the extremities secondary to ischemia.

  • Absence of, or unsuccessful coronary revascularization of the qualifying AMI referred to in inclusion criterion 3

Major exclusion criteria:

• Intracranial bleed

• Uncorrected intracranial vascular abnormality

• GI bleed within one year of screening

• Oral triple antithrombotic therapy

• Dialysis