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 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 HPI Smart-BP trial is a multicenter, interventional, randomized trial to determine if the use of a protocolized strategy using advanced hemodynamic monitoring with Acumen Hypotension Prediction Index (HPI) software guidance for intraoperative hemodynamic management reduces postoperative complication rate in moderate- to high-risk noncardiac surgery. The Acumen HPI software is used on-label in the HPI SMART-BP 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 transcatheter heart valve (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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CAUTION – Investigational devices. Limited by Federal (United States) law to investigational use.
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