Trial Summary
What is the purpose of this trial?
This trial is testing a new heart valve that can be inserted without surgery in patients with severe heart valve narrowing. The new valve helps improve blood flow by replacing the damaged one through a minimally invasive procedure.
Research Team
Rahul Sharma, MD
Principal Investigator
Stanford University
TM
Tamim M. Nazif, MD
Principal Investigator
Columbia University
Eligibility Criteria
This trial is for individuals with severe, calcified aortic stenosis who are experiencing symptoms and have at least a moderate functional impairment due to the condition. They must understand the study and consent to participate. Exclusions include pregnancy, recent heart attacks or procedures, certain heart diseases, planned surgeries, extreme obesity (BMI > 50), very low life expectancy or ejection fraction, blood disorders, active infections including COVID-19.Inclusion Criteria
I have severe, calcified aortic stenosis.
The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Your aortic valve size is suitable for the SAPIEN X4 THV.
See 1 more
Exclusion Criteria
I have not had a heart attack in the last 30 days.
I have severe leaking or significant narrowing of my mitral heart valve.
I cannot take blood thinning medications due to my condition.
See 28 more
Treatment Details
Interventions
- SAPIEN X4 THV (Transcatheter Heart Valve)
Trial OverviewThe SAPIEN X4 Transcatheter Heart Valve (THV) is being tested for safety and effectiveness in treating symptomatic severe calcific aortic stenosis. The study aims to see if this valve can improve heart function without major surgery by implanting it through a catheter.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: TAVR - Main CohortExperimental Treatment1 Intervention
Subjects will undergo transcatheter aortic valve replacement (TAVR)
Group II: TAVR - Bicuspid RegistryExperimental Treatment1 Intervention
Subjects with bicuspid aortic valve morphology will undergo TAVR
SAPIEN X4 THV is already approved in Canada for the following indications:
Approved in Canada as SAPIEN X4 THV for:
- Severe aortic stenosis in patients at high risk for surgical complications
- Failing aortic bioprosthetic valves
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