Clinical Trials

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

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

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 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 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

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 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

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 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

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

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

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

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