Trial Summary
What is the purpose of this trial?
This study will confirm the procedural safety and performance of the SAPIEN 3 Ultra System in subjects with severe, calcific AS who are at intermediate operative risk for standard aortic valve replacement.
Research Team
John Webb, MD
Principal Investigator
St. Paul's Hospital
BP
Bernard Prendergast, Prof
Principal Investigator
St. Thomas Hospital
Eligibility Criteria
This trial is for patients with severe, calcific aortic stenosis who are at intermediate risk for open heart surgery. They must understand the study and consent to participate, have specific heart function classifications (NYHA class ≥ II), and meet certain echocardiogram criteria. Exclusions include complex coronary disease, intolerance to antithrombotic therapy, pregnancy in women of childbearing potential, participation in other studies, certain heart conditions like hypertrophic cardiomyopathy or valve issues, severe ventricular dysfunction or regurgitation problems.Inclusion Criteria
The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
My heart valve is severely narrowed and has calcium deposits.
My heart team considers me at intermediate risk for open heart surgery.
See 1 more
Exclusion Criteria
You have a mechanical or bioprosthetic valve in your heart.
I have severe high blood pressure in the lungs.
I have kidney problems or am on dialysis.
See 28 more
Treatment Details
Interventions
- SAPIEN 3 Ultra System (Transcatheter Valve Replacement)
Trial OverviewThe SAPIEN 3 Ultra System is being tested for safety and performance in replacing the aortic valve using a less invasive method than open-heart surgery. This system includes both the delivery mechanism and the actual replacement valve designed specifically for people with narrowed valves due to calcium buildup.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Transcatheter Aortic Valve Replacement (TAVR)Experimental Treatment1 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