Clinical Research

Advancing Heart Valve Research

At the Marcus Heart Valve Center, we actively engage in heart valve research. This allows us to offer customized diagnostic and therapeutic options for patients that may otherwise not be accessible.

Our leading-edge cardiac research program is focused on evaluating new treatments and technologies, particularly percutaneous (non-surgical/minimally invasive) treatment options for all heart valves.

Currently Enrolling Research Trials

Aortic

ALIGN-AR

ALIGN AR: A Study to Assess Safety and Effectiveness of the JenaValve Trilogy™ Heart Valve System in the Treatment of High Surgical Risk Patients with Symptomatic, Severe Aortic Regurgitation (AR).

ALLIANCE AVIV

Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves.

ENVISION

Evaluation of the Navitor Transcatheter Heart Valve in Low and Intermediate Risk Patients who have Severe, Symptomatic, Aortic Stenosis Requiring Aortic Valve Replacement.

PROGRESS CAP

A Prospective, Randomized, Controlled Trial to Assess the Management of Moderate Aortic Stenosis by Clinical Surveillance or Transcatheter Aortic Valve Replacement.

SEIGEL TAVR EFS

Siegel Transcatheter Aortic Valve Replacement System (Siegel TAVR) To evaluate the safety and feasibility of Siegel™ TAVR System in the treatment of subjects with symptomatic severe native aortic stenosis..

Mitral

APOLLO

Transcatheter Mitral Valve Replacement with the Medtronic Intrepid™ TMVR System in patients with severe symptomatic mitral regurgitation – APOLLO Trial.

CLASP II

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 PASCA.

ENCIRCLE

SAPIEN M3 System TransCatheter MItral Valve ReplaCement via TransseptaL Access.

HighLife EFS

An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System.

PRIMARY

Percutaneous or Surgical Repair in Mitral Prolapse for > 65 Year-olds.

REPAIR-MR

Percutaneous MitraClip™ Device or Surgical Mitral Valve Repair in Patients with Primary Mitral Regurgitation who are Candidates for Surgery.

SUMMIT

Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation.

TWIST-EFS

Prospective, single-arm, early feasibility study (EFS) for the treatment of subjects with moderate-severe or severe symptomatic mitral valve regurgitation using the Innovalve Transseptal Mitral Valve Replacement (TMVR) System.