Adult Cardiac

Clinical Trials

Last updated: March 2024

Open Trials

CLASP IID/IIF Pivotal Clinical Trial

Sponsor: Edwards Lifesciences
Duration: Approximately 5 years
Study Lead or PI: William Hiesinger, MD

A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASCAL Transcatheter Valve Repair System compared to Abbott MitraClip in patients with mitral regurgitation.

Eligibility: Patients with symptomatic functional and degenerative mitral regurgitation and who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team.

Terminate AF Study

Sponsor: Medtronic
Duration: Approximately 5 years
Study Lead or PI: Anson, Lee, MD

The purpose of this study is to evaluate the safety and effectiveness of the Cardioblate Surgical Ablation iRF and CryoFlex handheld devices to support an indication expansion to include treatment of non-paroxysmal atrial fibrillation to the product labeling.

Eligibility: Adults with non-paroxysmal AF (persistent or longstanding persistent atrial fibrillation)

The purpose of this research study is to assess the clinical effectiveness of the MitraClip™ system for treating patients who are candidates for Mitral Valve (MV) repair surgery, with the intent to expand the indication for MitraClip™. The MitraClip™ system will be compared against MV repair surgery which is the current standard of care for patients with Primary Mitral Regurgitation (MR) who are candidates for mitral valve surgery.

Eligibility: Patients ages 18 and older who: have severe primary mitral regurgitation (MR), candidate of both the MitraClip™ device and MV repair surgery, are symptomatic or asymptomatic with LVEF ≤ 60%, pulmonary artery pressure systolic pressure > 50 mmHg, or LVESD > 40 mm, and are at moderate surgical risk.

The purpose of this study is to evaluate the safety and effectiveness of the NEXUS™ Aortic Arch Stent Graft System for the endovascular treatment of thoracic aortic lesions involving the aortic arch including chronic dissections, aneurysms, penetrating aortic ulcers and intramural hematoma.

Eligibility: Patients ages 18 and older who have been diagnosed with one of the following: chronic aortic arch dissection, aortic arch aneurysm, penetrating aortic ulcer, aortic intramural hematoma.

The APOLLO Trial is studying the safety and efficacy of an investigative device called the Intrepid Transcatheter Mitral Valve Replacement System. The Intrepid device is a heart valve that is designed to help alleviate mitral regurgitation so that blood can flow through your heart in the intended direction.

Eligibility: Patients with moderate-to-severe or severe symptomatic mitral regurgitation who, by agreement of the local site multidisciplinary heart team experienced in mitral valve therapies, may not be optimally treated with approved transcatheter repair or surgical mitral valve intervention.

The Organ Care System (OCS™) Lung Thoracic Organ Perfusion (TOP) Registry for Donor Lungs for Transplantation

Sponsor: Transmedics, Inc
Duration: Approximately 5 years
Study Lead or PI: Anson Lee, MD

The purpose of this study is to collect additional real-world safety and effectiveness data for the OCS™ Lung System and to expand the long-term clinical evidence supporting the use of OCS™ Lung System in lung transplantation from standard criteria donors and donors initially deemed unacceptable for procurement and transplantation due to the limitations of cold static preservation

Eligibility: All lung transplant recipients whose donor lungs were preserved on the OCS™ Lung System.

Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG (PACeS)

Sponsor: CTSN
Duration: Approximately 6 months
Study Lead or PI: Jack Boyd, MD

The overall objective of this study is to evaluate the effectiveness (prevention of thromboembolic events) and safety (major bleeding) of adding oral anticoagulation (OAC) to background antiplatelet therapy in patients who develop post-operative atrial fibrillation (POAF) after isolated coronary artery bypass graft (CABG) surgery.

Eligibility: Patients at least 18 years of age undergoing isolated coronary artery bypass grafting (CABG) surgery for coronary artery disease (CAD), and experiencing postoperative atrial fibrillation (POAF) that persists for >60 minutes or is recurrent within 7days after the CABG surgery.

CentriMag Failure-to-Wean Post-Approval Study

Sponsor: Abbott
Duration: 30 days or until discharge
Study Lead or PI: William Hiesinger, MD

The primary objective of this PAS is to report the proportion of patients surviving to 30 days post CentriMag support or to hospital discharge, whichever is longer. For subjects who do not recover and are bridged to a heart transplant or a long-term assist device, the primary endpoint is survival to induction of anesthesia for the surgery.

Eligibility: Patients who are 18 years and older and have a CentriMag Circulatory Support System implanted due to fail-to-wean (FTW) from cardiopulmonary bypass (CPB).

Global Utilization and Registry Database for Improved Heart Preservation (GUARDIAN)

Sponsor: Paragonix, Inc
Duration: Approximately 1 Year
Study Lead or PI: Yasuhiro Shudo, MD

The objective of this registry is to collect and evaluate various clinical effectiveness parameters in patients with transplanted donor hearts that were preserved and transported within the SherpaPak Cardiac Transport System, as well as retrospective standard of care patients.

Eligibility: Patients who already received transplants using donor hearts transported with the SherpaPak System, including children, adults, and older adults.

Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY)

Sponsor: CTSN
Duration: Approximately 10 Years
Study Lead or PI: Jack Boyd, MD

The PRIMARY Study is a prospective, multicenter, open-label, randomized trial comparing MV transcatheter edge-to-edge repair to surgical repair (1:1 ratio) in patients with primary, degenerative MR.

Eligibility: Patients 65 years or older with severe, primary degenerative MR for whom the local heart team has verified that an indication for MV intervention is present and for whom both transcatheter edge-to-edge and surgical repair strategies are anatomically feasible.

Hybrid Epicardial and Endocardial Sinus-Node SpAring AbLation Therapy for
Inappropriate Sinus Tachycardia (HEAL-IST IDE Trial)

Sponsor: Atricure, Inc
Duration: Approximately 2 Years
Study Lead or PI: Anson Lee, MD

The HEAL-IST Study is a prospective, multi-center, single arm, Bayesian Adaptive Design, IDE trial evaluating the safety and effectiveness of a hybrid sinus node sparing ablation procedure using the ISOLATOR Synergy Surgical Ablation System for the treatment of symptomatic drug refractory or drug intolerant IST.

Eligibility: Subjects who have symptomatic IST but are refractory or intolerant to rate control drugs (e.g., beta-blockers/calcium channel blockers, ivabradine), and/or AADs

Perioperative Factors That Drive Cell-free Hemoglobin-Mediated Primary Graft Dysfunction

Sponsor: Vanderbilt University Medical Center
Duration: 5 days
Study Lead or PI: John MacArthur, MD

This is an observational clinical study of LT patients that will evaluate the mechanistic impact of CFH on PGD.

Eligibility: We are evaluating how the build-up of cell-free hemoglobin (CFH) in the lungs and bloodstream may contribute to injury to the newly transplanted lung. One type of lung injury is called primary graft dysfunction (PGD). PGD happens within 72 hours after transplant in 10-30% of lung transplant (LT) recipients. Patients who develop severe PGD have higher risk of rejection and chronic lung allograft dysfunction (CLAD). Our goal is to understand what causes PGD so that we can develop new treatments to prevent this complication of lung transplant.

A Prospective, global study designed to collect real-world clinical outcomes of the MITRIS RESILIA mitral valve – North America (MOMENTIS)

Sponsor: Edwards Lifesciences
Duration: Approximately 10 years
Study Lead or PI: John W. MacArthur, MD

The purpose of this study is to collect data on short and long-term outcomes of the MITRIS RESILIA mitral valve in subjects requiring replacement of their native (original) or prosthetic (artificial) mitral valve.

Eligibility: Adult patients (18 years or older) diagnosed with mitral valve disease requiring a planned replacement of the native or prosthetic mitral valve. Concomitant coronary bypass surgery and ascending aorta resection and replacement from the sinotubular junction without the need for circulatory arrest were permitted.

Upcoming Trials

Carmat Total Artificial Heart Early Feasibility Study

Sponsor: CARMAT
Duration: To be announced
Study Lead or PI: William Hiesinger, MD

To study the Carmat total artificial heart as a treatment for transplant-eligible patients in severe, end-stage heart failure

Eligibility: To be announced

ARISE II -The Evaluation of the GORE Ascending Stent Graft (ASG device) in the treatment of Lesions of the Ascending Aorta.

Sponsor: Gore
Duration: Approximately 5 years
Study Lead or PI: Amelia Claire Watkins, MD

Assess the safety and effectiveness of the ASG device in the treatment of lesions involving the ascending aorta and aortic arch.

Eligibility: Patients considered to be at high risk for open surgical repair who present with the following pathologies of the ascending aorta and aortic arch.

IMPRoving Outcomes in Vascular DisEase – Aortic Dissection (IMPROVE-AD)

Sponsor: Duke University
Duration: Approximately 6 years
Study Lead or PI: John W. MacArthur, MD

The primary objective of the IMPROVE-AD trial is to determine whether an upfront invasive strategy of TEVAR plus medical therapy reduces the occurrence of a composite endpoint of all-cause death or major aortic complications compared to an upfront conservative strategy of medical therapy with surveillance for deterioration in patients with uncomplicated type B aortic dissection

Eligibility: Patients diagnosed with a type B aortic dissection

RECHARGE-REvascularization CHoices Among UnderRepresented Groups Evaluation: The RECHARGE Trial

Duration: Approximately 10 years
Study Lead or PI: Jack Boyd, MD

To compare the effect of percutaneous coronary intervention (PCI) vs coronary artery bypass grafting (CABG) on survival and improvement in quality-of-life (QOL) in women (RECHARGE:Women) and To compare the effect of PCI vs CABG on survival and improvement in QOL in patients who are either Black or Hispanic (RECHARGE:Minorities

Eligibility: Adult patients (≥18 years) of female sex and/or Black race or Hispanic ethnicity with multivessel or left main coronary artery disease (CAD) intended for revascularization and for whom there is equipoise between CABG and PCI according to local Heart Team assessment

The primary objective is to evaluate the efficacy of RBT-1 compared with placebo on a hierarchical composite (win ratio) of the following components: death, incidence of acute kidney injury (AKI) requiring dialysis, intensive care unit (ICU) days, and 30-day cardiopulmonary readmission.

Eligibility: Phase 3, multi-center, randomized, double-blind, placebo-controlled study to evaluate the effect of RBT-1 on reducing the risk of post-operative complications in subjects undergoing coronary artery bypass graft (CABG) and/or cardiac valve surgery on CPB. Patients will be randomized to receive a single administration of placebo (normal saline) or RBT-1 via intravenous (IV) infusion between 24 and 48 h prior to scheduled cardiac surgery.

Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
(LeAPPS Study)

Sponsor: Atricure, Inc
Duration: Enrollment is expected to take approximately 4 years. With an expected follow up of 5 years, the total duration of the trial is approximately 9 years.
Study Lead or PI: Anson Lee, MD

To demonstrate the effectiveness of LAA exclusion (LAAE) for the prevention of ischemic stroke or systemic arterial embolism in subjects undergoing cardiac surgery who have risk factors for atrial fibrillation and ischemic stroke.

Eligibility: Prospective, randomized, multicenter, multinational, blinded, superiority trial looking at patients 18 years of age or older, undergoing planned cardiac surgery, without documented clinical diagnosis of atrial fibrillation, who also present with documented risk factors for developing atrial fibrillation and ischemic stroke.

The primary objective of this registry is to capture the real-world data on the outcome of AtriCure Isolator® Synergy™ Surgical Ablation system (or future iterations) when used to ablate cardiac tissue in patients with Inappropriate Sinus Tachycardia (IST) or Postural Tachycardia Syndrome (POTS) using sinus node sparing hybrid ablation procedures. This is an observational, retrospective and prospective, multicenter, open-label patient registry.

Eligibility: The IST registry eligibility is open to sites and physicians performing the described treatments for patients diagnosed with IST and POTS. Subjects must have been scheduled to undergo or have undergone the described treatments for IST or POTS by their physicians and must meet all eligibility criteria in order for their treatment and results to be considered for this Registry.

A Prospective, Multi-center, Single-Arm, Open-Label Study of Hearts Transplanted after Non-Ischemic Heart PRESERVation from Extended Donors) (PERSERVE Heart Study)

Sponsor: XVIVO Perfusion, Inc
Duration: Total duration of study is estimated at 42 months.
Study Lead or PR: Yasuhiro Shudo, MD

To evaluate if Non-Ischemic Heart Preservation (NIHP) of extended criteria donor hearts using the XVIVO Heart Preservation System (XHPS) is a safe and effective way to preserve and transport hearts for transplantation.

Eligibility: The XVIVO Heart Preservation System (XHPS) is indicated for hypothermic non-ischemic oxygenated perfusion of excised donor hearts for preservation and transport to transplant. This device is intended to be used for extended criteria donor hearts with the intention of transplant into a recipient aged 18 or older.

Underway but not accepting new patients

GORE TAG Thoracic Branch Endoprosthesis to Treat Aortic Lesions

Sponsor: Gore
Duration: 5 years
Study Lead or PI: Michael Fischbein, MD, PhD

This study will explore whether the GORE TAG Thoracic Branch Endoprosthesis, similar to a stent, can be used to repair disease and injury to the aortic arch and/or the descending thoracic aorta.

Eligibility: Adult patients with aortic lesions who haven’t had previous repair surgeries

A Prospective, Single Arm, Multi-center Clinical Investigation to Evaluate the Safety and Effectiveness of the Ascyrus Medical Dissection Stent (AMDS) in the Treatment of Acute DeBakey Type I Dissection

Eligibility:Patients ages 18-80 with acute DeBakey type I dissection and have presence of organ malperfusion (cerebral, visceral, renal, spinal cord, andperipheral).

Destination Therapy Post Approval Study (DT PAS)

Sponsor: Medtronic
Duration: Approximately 5 years
Study Lead or PI: William Hiesinger, MD

Medtronic is sponsoring the HeartWare™ HVAD™ Destination Therapy (DT) Post Approval Study (PAS) to further confirm safety and effectiveness of the HeartWare Ventricular Assist Device System (HVAD System) when used as intended, in "real-world" clinical practice.

Eligibility:Patients intended to be implanted with a HVAD for use as a destination therapy are eligible for enrollment into the DT PAS and must be consented for the PAS prior to the HVAD implant.

Apogee, A HeartWare HVAD Destination Product Surveillance Registry (PSR) Platform

Sponsor: Medtronic
Duration: 12 months
Study Lead or PI: William Hiesinger, MD

Medtronic is sponsoring the Apogee study to further enhance scientific understanding of the implant procedure, optimized blood pressure management, and anticoagulation/ antiplatelet therapy in patients receiving a Medtronic HeartWare™ Ventricular Assist Device (HVAD™) for destination therapy.

Eligibility: Patients enrolled in DT PAS (NCT03681210) are eligible for enrollment into Apogee and must be consented on the separate Apogee consent.