Compassion S3 for Transcatheter Heart Valve Placement in Adults and Children

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:<ul>
<li>Weigh at least 20 kg (about 44 pounds)</li>
<li>Have a dysfunctional conduit or previously implanted valve</li>
<li>Not have a current infection</li>
<li>Not have any known blood clotting disorder</li></ul>

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?

If you agree to be in the study, you will:<ul>
<li>Have the SAPIEN 3 Valve (study valve) implanted to your dysfunctional valve or conduit through cardiac catheterization</li>
<li>Have 10 onsite visits over 5 years</li>
<li>Have echocardiogram, exercise test, chest x-ray, and chest fluoroscopy during the study</li></ul>

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