Compassion S3 for Transcatheter Heart Valve Placement in Adults and Children - Clinical Trial
What is the Purpose of this Study?
We are doing this study to learn if SAPIEN 3 valve system is safe and will work with adults and children who have a dysfunctional right ventricular outflow tract (RVOT) conduit or have an implanted valve in the pulmonic position.
Dysfunctional pulmonary valve
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