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.
Who Can Participate?
Eligibility
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 Range
0-100
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
Yes
What is Involved?
Description
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
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
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
Gregory
Fleming
Protocol Number
PRO00070466
NCT ID
NCT02744677
Phase
N/A
Enrollment Status
Open to Enrollment