Compassion S3 for Transcatheter Heart Valve Placement in Adults and Children - Clinical Trial

Email to Participate

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