Compassion S3 for Transcatheter Heart Valve Placement in Adults and Children - Clinical Trial
What is the Purpose of this Study?
Who Can Participate in the Study?
To be in this study, you must:
- Weigh at least 20 kg (about 44 pounds)
- Have a dysfunctional conduit or previously implanted valve
- Not have a current infection
- Not have any known blood clotting disorder
What is Involved?
If you agree to be in the study you will:
- have the SAPIEN 3 Valve (study valve) implanted to your dysfunctional valve or conduit through cardiac catheterization.
- Have 10 onsite visits over 5 years
- Have echocardiogram, exercise test, chest x-ray, and chest fluoroscopy during the study