SAPIEN 3 THV for Aortic Stenosis
(P3 Trial)
Recruiting at 76 trial locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Edwards Lifesciences
No Placebo Group
Trial Summary
What is the purpose of this trial?
To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement.
Research Team
MJ
Michael J Mack, MD, FACC
Principal Investigator
The Heart Hospital Baylor Plano, TX
MB
Martin B Leon, MD, FACC
Principal Investigator
Columbia University Medical Center/ New York Presbyterian Hospital, NY
Eligibility Criteria
The PARTNER 3 Trial is for patients with severe, calcified aortic stenosis who are at low risk for standard valve replacement surgery. Participants must have symptoms or test results showing heart function issues and agree to the study's terms. Those with recent strokes, extreme obesity, short life expectancy, refusal of blood products, certain infections or diseases, unsuitable heart valve sizes or conditions that prevent safe procedure completion cannot join.Inclusion Criteria
A group of heart doctors decides that the patient has a high risk of dying from surgery and has a Society of Thoracic Surgeons (STS) score of less than 4.
I have heart issues affecting my daily activities or exercise ability.
I have severe narrowing of my heart's aortic valve with calcium buildup.
See 1 more
Exclusion Criteria
I have a history of cirrhosis or currently have liver disease.
I have a blood disorder affecting my white cells, red cells, or platelets.
I have not had a stroke or mini-stroke in the last 3 months.
See 30 more
Treatment Details
Interventions
- SAPIEN 3 THV (Transcatheter Heart Valve)
Trial OverviewThis trial tests the safety and effectiveness of the SAPIEN 3 Transcatheter Heart Valve (THV) compared to standard surgical aortic valve replacement (SAVR). It targets patients with severe aortic stenosis but considered low-risk for traditional surgery. The goal is to see if THV can be an alternative treatment option.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Transcatheter aortic valve replacement (TAVR)Experimental Treatment1 Intervention
Group II: Surgical aortic valve replacement (SAVR)Active Control1 Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Edwards Lifesciences
Lead Sponsor
Trials
188
Recruited
67,500+
Founded
1958
Headquarters
Irvine, California, U.S.
Known For
Structural Heart Innovations
Top Products
SAPIEN Transcatheter Heart Valve, EVOQUE System, PASCAL Precision, SAPIEN M3
Todd Brinton
Edwards Lifesciences
Chief Medical Officer since 2023
MD from Stanford University
Bernard Zovighian
Edwards Lifesciences
Chief Executive Officer since 2023
MBA from INSEAD