Welcome to the Edwards Lifesciences Clinical Research program. Here you can search all Edwards active clinical trials, understand what treatments and disease states are being investigated, and learn about trial design and inclusion criteria. We're glad you're here.
The ALLIANCE program consists of multiple clinical trials. The ALLIANCE trial (pivotal study) will explore the safety and effectiveness of the Edwards SAPIEN X4 transcatheter heart valve system for patients with symptomatic, severe, calcific aortic stenosis. The ALLIANCE aortic valve-in-valve trial will be conducted among subjects who have a failing aortic surgical or transcatheter bioprosthetic valve. This trial is currently enrolling.
A prospective, multicenter, randomized, double-blinded, sham-controlled trial to assess the safety, performance, and effectiveness of the Edwards APTURE transcatheter shunt system for the treatment of patients with heart failure (HF) with mildly reduced (HFmrEF) or preserved (HFpEF) ejection fraction (LVEF >40%) with elevated left atrial pressure who remain symptomatic despite guideline-directed medical therapy (GDMT).
The CLASP II TR clinical trial study is to determine the safety and effectiveness of the Edwards PASCAL transcatheter valve repair system, a device designed to repair the tricuspid valve with no open heart surgery. This trial is meant for patients with severe, symptomatic tricuspid regurgitation, despite current medical therapy.
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 with Abbott MitraClip in patients with degenerative mitral regurgitation.
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 with Abbott MitraClip in patients with functional mitral regurgitation.
The EARLY TAVR trial has completed enrollment. The EARLY TAVR trial will examine the safety and effectiveness of the Edwards SAPIEN 3/ SAPIEN 3 Ultra transcatheter heart valve (THV) versus clinical surveillance in patients with severe calcific aortic stenosis without symptoms.
This clinical trial will evaluate the safety and effectiveness of the SAPIEN M3 system in patients with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are deemed unsuitable.
The HPI Care trial is designed to determine whether the use of the Acumen Hypotension Prediction Index (HPI) software to guide hemodynamic management in patients undergoing cardiac surgery requiring cardiopulmonary bypass reduces the mean duration of hypotension (defined as MAP < 65 mmHg) from the post-bypass period in the cardiac operating room (OR) and the cardiovascular intensive care unit (CVICU). The Acumen HPI software is used on-label in the HPI-CARE Trial and is not an investigational device.
The PROGRESS trial is a prospective, randomized, controlled trial to evaluate the safety and effectiveness of the SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA transcatheter heart valves (THV) versus clinical surveillance in patients with moderate calcific aortic stenosis.
The TRISCEND II clinical trial is to determine the safety and effectiveness of the EVOQUE valve, a device designed to replace the tricuspid valve with no open heart surgery. This trial is for patients with severe or greater tricuspid regurgitation.
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Limited by Federal (United States) law to investigational use.
