Clinical Trials

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

Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP IID/IIF): 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.

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 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

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

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 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

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 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 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

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 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 children, adults, and older adults.

Study Duration: 1 Year

Study Lead: Yasuhiro Shudo, MD

More information on ClinicalTrials.gov

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.

Who might be eligible: 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.

Study Duration: 10 years

Principal Investigator: Jack Boyd, MD

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 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

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

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