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.

What is the Condition Being Studied?

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
Age Group
Adults, Children

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

Study Details

Full Title
COMPASSION S3: COngenital Multicenter trial of Pulmonic vAlve dysfunction Studying the SAPIEN 3 interventIONal THV (former Duke IRB title: Implantation of the SAPIEN 3 Transcatheter Heart Valve (THV) In the Pulmonic Position)
Principal Investigator
Pediatric Cardiologist
Protocol Number
IRB: PRO00070466
NCT: NCT02744677
Phase N/A
Enrollment Status
Open for Enrollment