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 examined 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.
The main ENCIRCLE trial is no longer enrolling patients. The Failed TEER registry is currently enrolling patients who have had an attempted but failed transcatheter edge-to-edge repair (TEER) procedure. The ENCIRCLE trial evaluates 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 JOURNEY trial will assess the safety and efficacy of the J-Valve transfemoral (TF) system in patients with symptomatic, severe (grade 3 or 4), native AR and AR-dominant mixed aortic valve disease, who are judged by a multidisciplinary heart team to be at high risk for open SAVR.
This trial has completed enrollment. 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 PROGRESS CAP study will continue enrolling patients at participating sites to increase representation of all populations.
The TRISCEND II clinical trial is no longer enrolling patients. The TRISCEND II trial purpose 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.
We are committed to providing the highest levels of customer service to help our patients improve their quality of life. For any questions, please contact the Edwards Patient Support Center.
Give us a call
Send us an email
As a member of the Advanced Medical Technology Association (“AdvaMed”), Edwards strictly adheres to the requirements of the AdvaMed Code of Ethics on Interactions with Health Care Professionals.
Limited by Federal (United States) law to investigational use.