Clinical Trials

This study is a prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASCAL Transcatheter Mitral Valve Repair System compared to Abbott MitraClip in patients with degenerative mitral regurgitation (DMR) and who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team.

Who might be eligible: Adults with degenerative mitral regurgitation (DMR)

Study Duration: Approximately 5 years

Study Lead: William Hiesinger, MD

More information on ClinicalTrials.gov

This study is being performed to see whether RBT-1, an investigational new drug, can increase proteins (biomarkers)
in the body that are associated with protecting organs from injury. This study will enroll patients who are undergoing non-emergent coronary artery bypass graft (CABG) and/or cardiac valve surgery requiring cardiopulmonary bypass (heart-lung machine) and who have risk factors for kidney injury.

Who might be eligible: Patients ages 18 and older who: have stable kidney function and no epidosdes of AKI  four weeks prior to to undergoing non-emergent coronary and/or valve surgery(ies) requiring cardiopulmonary bypass.

Study Duration: 3 Months

Study Lead: John MacArthur, MD

More information on ClinicalTrials.gov

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.

Who might be eligible: All lung transplant recipients whose donor lungs were preserved on the OCS™ Lung System.

Study Duration: 5 Years

Study Lead: Anson Lee, MD

More information on ClinicalTrials.gov

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.

Who might be eligible: 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.

Study Duration: 10 Years

Study Lead: John MacArthur, MD

More information on ClinicalTrials.gov

This research study will be used to determine if apixaban is non-inferior to warfarin and provides acceptable anticoagulation for patients with an On-X mechanical aortic valve.

Who might be eligible: Patients ages 18 and older who are: able to receive warfarin with target INR 2-3, able to take a low dose aspirin of 75-100 mg daily or have a documented contraindication to aspirin use, and implantation of an On-X mechanical valve replacement in the aortic position at least 3 months ago.

Study Duration: 2 years

Study Lead: Michael Fischbein, MD

More information on ClinicalTrials.gov

The purpose of this study is to evaluate the safety and effectiveness (usefulness) of the HARPOON™ Beating Heart Mitral Valve Repair System in the treatment of patients with severe degenerative mitral regurgitation (DMR). The HARPOON System is expected to be a valuable, minimally invasive treatment alternative for patients suffering from DMR. The HARPOON System is inserted into the heart during a surgical procedure which is intended to replace the broken chords (strings) with control the opening and closing of the mitral valve with a small chest incision and without a heart- lung machine.

Who might be eligible: Patients ages 21 and older with a presence of severe degenerative mitral regurgitation with isolated mid-segment posterior leaflet prolapse and Mitral leaflet coaptation surface sufficient to reduce mitral regurgitation without undue leaflet tension.

Study Duration: 5 Years

Study Lead: John MacArthur, MD

More information on ClinicalTrials.gov

The purpose of this study is study to determine the safety of the Investigational Product called XC001 in human research subjects suffering from angina caused by coronary artery disease who have no other treatment options.

Who might be eligible: Patients ages 18 to 80 who: have been diagnosed with chronic angina due to obstructive coronary artery disease that is refractory to drug therapy and unsuitable for revascularization, angina class II-IV, and
adequate hematologic, hepatic, and renal function.

Study Duration: Approximately 13.5 months

Study Lead: Juyong Brian Kim, MD

More information on ClinicalTrials.gov

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.

Who might be eligible: 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.

Study Duration: Approximately 6 months

Study Lead: Jack Boyd, MD

More information on ClinicalTrials.gov

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.

Who might be eligible: 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).

Study Duration: 30 days or until discharge

Study Lead: William Hiesinger, MD

More information on ClinicalTrials.gov

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.

Who might be eligible: 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.

Study Duration: 5 Years

Study Lead: Amelia Claire Watkins, MD

More information on ClinicalTrials.gov

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.

Who might be eligible: Patients who already received transplants using donor hearts transported with the SherpaPak System, including chlidren, adults, and older adults.

Study Duration: 1 Year

Study Lead: Yasuhiro Shudo, MD

More information on ClinicalTrials.gov

The purpose of this research study is to evaluate the regimen of blood-thinning medications taken by patients with advanced heart failure treated with the HeartMate 3™ LVAD.

Who might be eligible: Advanced heart failure patients being treated with the HeartMate 3 Left Ventricular Assist System (LVAS).

Study Duration: Up to 3 Years

Study Lead: William Hiesinger, MD

More information on ClinicalTrials.gov

The objective of this trial is to assess the safety and effectiveness of the study device in subjects with degenerative mitral valve disease receiving a mitral valve repair without cardiopulmonary bypass (treatment group) when compared to subjects receiving mitral valve repair using standard surgical techniques with cardiopulmonary bypass (control group).

Who might be eligible: Patient intended to undergo mitral valve repair with cardiopulmonary bypass

Study Duration: 5 Years

Study Lead: Jack Boyd, MD

More information on ClinicalTrials.gov

A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type A (AGN-151607) Injections into the Epicardial Fat Pads to Prevent Post-Operative Atrial Fibrillation in Patients Undergoing Open-Chest Cardiac Surgery

Who might be eligible: Patients intended to undergo open-chest cardiac surgery

Study Duration: 1 Year

Study Lead: Anson Lee, MD

More information on ClinicalTrials.gov

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.

Who might be eligible: Adults with non-paroxysmal AF (persistent or longstanding persistent atrial fibrillation)

Study Duration: Approximately 5 years

Study Lead: Anson Lee, MD

More information on ClinicalTrials.gov

The APOLLO Trial is a multi-center, global, prospective, randomized, interventional, pre-market trial with two subject groups: the randomized group will be randomized on 1:1 basis to either the study device or to conventional mitral valve surgery. Subjects in the single-arm group will receive the study device.

Who might be eligible: Patients with severe, symptomatic mitral regurgitation and are a candidate for bioprosthetic mitral valve replacement

Study Duration: 5 years

Study Lead: Jack Boyd, MD

More information on ClinicalTrials.gov

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.

Who might be eligible: Adult patients with aortic lesions who haven’t had previous repair surgeries

Study Duration: Up to 4 years

Study Lead: Michael Fischbein, MD

More information on ClinicalTrials.gov

The objective of this trial is to assess the safety and effectiveness of the NeoChord DS1000 minimally invasive system to replace the chordae in mitral valve repair surgeries without cardiopulmonary bypass, by comparing those patients’ outcomes to those of patients who undergo standard mitral valve repair surgeries with chordae replacement while on cardiopulmonary bypass.

Who might be eligible: Patients with moderate to severe degenerative mitral valve regurgitation, isolated mitral valve prolapse, and are a candidate for mitral valve repair without cardiopulmonary bypass

Study Duration: 5 years

Study Lead: Joseph Woo, MD

More information on ClinicalTrials.gov

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

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

Study Duration: 5 Years

Study Lead: Amelia Claire Watkins, MD

More information on ClinicalTrials.gov

The purpose of this research study is to capture and evaluate certain vital sign data when a urinary Foley catheter is in place after cardiac surgery in patients while hospitalized.

Who might be eligible: Patients who have had cardiac surgery, or will be having cardiac surgery, and require a Foley catheter to drain their bladder after their surgery.

Study Duration: 5 years

Study Lead: Jack Boyd, MD

More information on ClinicalTrials.gov

This clinical trial examines whether the Medtronic Harmony prosthetic pulmonary valve can safely improve heart function when inserted through a catheter.

Who might be eligible: Patients with congenital heart disease and pulmonary regurgitation who are clinically indicated for pulmonary valve replacement, with no pre-existing prosthetic heart valve or ring

Study Duration: 5 Years

Study Lead: Doff McElhinney, MD

More information on ClinicalTrials.gov

A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the RelayPro in Subjects with Acute, Complicated Type B Aortic Dissections.

Who might be eligible: Patients ages 18 and older with acute, complicated type B aortic dissection.

Study Duration: 5 Years

Study Lead: Amelia Claire Watkins, MD

More information on ClinicalTrials.gov

The purpose of this study is to evaluate the effectiveness of the OCS Heart System to resuscitate, preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation.

Who might be eligible: Patients within the ages of 18 and 49 years who are primary heart transplant candidates

Study Duration: 1 Year

Study Lead: Yasuhiro Shudo, MD

More information on ClinicalTrials.gov

This study is a continuation of the OCS Heart DCD Trial. The purpose is enable continued clinical access to DCD heart transplantation in the U.S. and to continue to collect additional data on the performance of the OCS Heart System to resuscitate, preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation.

Who might be eligible: Patients ages 18 and older transplanted with the DCD heart instrumented on OCS.

Study Duration: 5 Years

Study Lead: Yasuhiro Shudo, MD

More information on ClinicalTrials.gov

Evaluation of the Thoraflex™ Hybrid Device for Use in the Repair or Replacement of the Ascending Aorta, Aortic Arch and Descending Aorta in an Open Surgical Procedure.

Who might be eligible: Patient who has acute dissection of the aorta, who has chronic dissection of the aorta or, who has an aortic aneurysm (including connective tissue disorders).

Study Duration: 3 Years

Study Lead: Joseph Woo, MD

More information on ClinicalTrials.gov

The primary objective of this phase 3 trial is to evaluate the efficacy and safety of the addition of the mesenchymal stromal cell (MSC) remestemcel-L plus standard of care compared to placebo plus standard of care in patients with acute respiratory distress syndrome (ARDS) due to SARS-CoV-2. The secondary objective is to assess the impact of MSCs on inflammatory biomarkers.

Who might be eligible: Patients who have SARS-CoV-2 (COVID-19) confirmed by RT-PCR assay or other diagnostic test and patient is requiring mechanical ventilatory support with moderate to severe ARDS.

Study Duration: 1 Year

Study Lead: John MacArthur, MD

More information on ClinicalTrials.gov

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.

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

Study Duration: 12 Months

Study Lead: William Hiesinger, MD

More information on ClinicalTrials.gov

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.

Who might be eligible: 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.

Study Duration: Approximately 5 years

Study Lead: William Hiesinger, MD

More information on ClinicalTrials.gov

The purpose of this study is to evaluate the Thoraguard Surgical Drainage System in a real-world clinical environment. It is believed that this system will offer functional and clinical benefits over the current standard of care system for the removal of surgical fluids following cardiac surgery. Observations, experiences, and outcomes in a single hospital setting will be collected for the Thoraguard Surgical Drainage System.

Who might be eligible: Non-emergent cardiac surgery patients undergoing one of the following procedures: coronary artery bypass grafting, aortic valve repair or replacement, mitral valve repair or replacement, ascending aortic surgery, a combination of these procedures, or in conjunction with additional procedures such as MAZE Procedure or left ventricular aneurysm repair.

Study Duration: Between 6 to 9.5 hours

Study Lead: Jack Boyd, MD

More information on ClinicalTrials.gov

The purpose of this trial is to evaluate whether use of the portable Organ Care System, which cools, ventilates and circulates blood through donor organs in transit, can make donor lungs viable for a longer window and/or improve clinical outcomes of patients who receive lungs transported this way.

Who might be eligible: Patients who are primary double lung transplant candidates

Study Duration: 3 years

Study Lead: Anson Lee, MD

More information on ClinicalTrials.gov

This study assesses whether it is safe and effective to use lithoplasty, rather than standard balloon angioplasty, with a drug-coated balloon to treat peripheral artery disease (PAD) that affects femoral or popliteal arteries.

Who might be eligible: Adults with moderate to severe peripheral artery disease who have not experienced tissue loss and do not have surgery scheduled on the affected limb

Study Duration: 2 years

Study Lead: A. Claire Watkins, MD

More information on ClinicalTrials.gov

The ACTIVE Trial is a prospective, randomized, multicenter trial. Patients with clinically significant functional mitral regurgitation will be randomized 2:1 to receive either transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT) or GDMT alone.

Who might be eligible: Patients with clinically significant functional mitral regurgitation (MR) and symptomatic heart failure

Study Duration: 5 years

Study Lead: Joseph Woo, MD

More information on ClinicalTrials.gov

To provide additional data evaluating the safety and effectiveness of the OCS™ Heart System to preserve and assess donor hearts that do not meet current standard donor heart acceptance criteria (as identified above) for transplantation to potentially improve donor heart utilization for transplantation at a range of transplant centers in the U.S. and to permit patients and physicians access to the OCS Heart System while a PMA application is under preparation and review.

Who might be eligible: Registered primary heart transplant candidate who is 18 years or older.

Study Duration: 12 Months

Study Lead: Yasuhiro Shudo, MD

More information on ClinicalTrials.gov

The purpose of this trial is to determine whether patients, who are undergoing surgery to treat mitral valve regurgitation and also have mild to moderate tricuspid regurgitation, will benefit from concurrent tricuspid valve repair.

Who might be eligible: Adult patients with degenerative mitral regurgitation

Study Duration: Up to 2 years

Study Lead: Joseph Woo, MD

More information on ClinicalTrials.gov

This study will track the safety and effectiveness of the HeartMate 3 Left Ventricular Assist System (LVAS) in patients who have advanced, treatment-resistant left ventricular heart failure and are referred for LVAS implantation surgery.

Who might be eligible: Adults with advanced left ventricular heart failure

Study Duration: Up to 2 years

Study Lead: William Hiesinger, MD

More information on ClinicalTrials.gov

This trial evaluates the safety and effectiveness of the Thoraflex Hybrid Device, which includes graft and stents, in treating a ruptured aorta or damaged aortic arch and descending aorta.

Who might be eligible: Adult patients with acute or chronic dissection of the aorta

Study Duration: 3 years

Study Lead: Michael Fischbein, MD

More information on ClinicalTrials.gov

This study investigates whether closing the small pouch at the top of the heart, called the left atrial appendage, can reduce the risk of stroke in patients with a history of atrial fibrillation. The left atrial appendage is present in everyone, but the irregular heart rhythm in atrial fibrillation may cause blood clots to form in it. The clots can travel through the bloodstream leading to stroke or injury to other organs. This study compares rates of ischemic stroke or transient ischemic attack in patients who have the LAA closed during surgery to rates among patients who undergo similar surgeries without having the LAA closed.

Who might be eligible: Adults with atrial fibrillation for whom heart surgery with the use of the cardiopulmonary bypass machine is recommended

Study Duration: About 4 years

Study Lead: Anson Lee, MD

More information on ClinicalTrials.gov

This study evaluates the safety and effectiveness of the HeartAssist 5 VAD System as a treatment to support patients waiting for heart transplant by comparing it to the FDA-approved devices Thoratec HeartMate II VAD and HeartWare HVAD.

Who might be eligible: Adults with end-stage heart failure who are approved for LVAD implantation

Study Duration: Up to 2 years

Study Lead: William Hiesinger, MD

More information on ClinicalTrials.gov

This study evaluates whether the HeartMate 3 Left Ventricular Assist System works at least as well as the previous model, HeartMate II LVAS, to treat advanced left ventricular heart failure that isn’t well managed by other treatments.

Study Lead: William Hiesinger, MD

More information on ClinicalTrials.gov

This trial evaluates the safety and efficacy of injecting stem cells called mesenchymal precursor cells into the heart muscle in patients with left ventricular assist devices (LVADs). The purpose is to see whether the stem cells can help ease heart failure in patients and how exactly they do so.    

Study Lead: Joseph Woo, MD

More information on ClinicalTrials.gov

This trial is evaluating the long-term safety and effectiveness of the Model 400 Aortic Valve Biological Prosthesis in patients who require replacement of the aortic valve.

Study Lead: Michael Fischbein, MD

More information on ClinicalTrials.gov

The objective of this trial is to confirm that the new methods of tissue processing, valve sterilization, and packaging for the latest models of Edwards bioprosthetic valves (the Edwards Pericardial Aortic Bioprosthesis Model 11000A and the Edwards Pericardial Mitral Bioprosthesis Model 11000M) do not raise new questions of safety or effectiveness over previous FDA-approved models. Bioprosthetic heart valves are used in patients with valvular heart disease who cannot safely take long-term anticoagulation medication.

Study Lead: Craig Miller, MD

More information on ClinicalTrials.gov

This trial assesses the safety and effectiveness of the Edwards INTUITY Valve System in patients with aortic valve disease. The device is designed to reduce the implant time by using only three sutures to put the valve in place. Data suggests that less time on cardiopulmonary bypass reduces the risk of complications.

Study Lead: Joseph Woo, MD

More information on ClinicalTrials.gov

This is an early-stage study to assess whether the GORE TAG Thoracic Branch Endoprosthesis can be used to treat aneurysms on the aortic arch. Surgeons will evaluate whether they can successfully deploy the Branched TAG Device and verify their success with angiography at the conclusion of the procedure.

Study Lead: Michael Fischbein, MD, PhD

More information on ClinicalTrials.gov

This study will explore whether the medical device called the GORE TAG Thoracic Branch Endoprosthesis can be used to repair aortic diseases and injuries that affect the aortic arch and/or the descending thoracic aorta.

Study Lead: Michael Fischbein, MD, PhD

More information on ClinicalTrials.gov