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Active, not recruiting No phase listed Observational

COMPASSION S3 Post-Approval Study

ClinicalTrials.gov ID: NCT04860765

Public ClinicalTrials.gov record NCT04860765. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 4:19 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Congenital Multicenter Trial of Pulmonic Valve Dysfunction Studying the SAPIEN 3 Interventional THV Post-Approval Study

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study will monitor device performance and outcomes of the SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted surgical valve in the pulmonic position with a clinical indication for intervention.

Study identification

NCT ID
NCT04860765
Recruitment status
Active, not recruiting
Study type
Observational
Phase
Not listed
Lead sponsor
Edwards Lifesciences
Industry
Enrollment
150 participants

Conditions and interventions

Eligibility (public fields only)

Age range
Not listed
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 13, 2021 (Actual)
Primary completion
Aug 2030 (Estimated)
Completion
Aug 2030 (Estimated)
Last update posted
Feb 3, 2026

2021 – 2030

United States locations

U.S. sites
19
U.S. states
15
U.S. cities
18
Facility City State ZIP Site status
University of Alabama Birmingham Alabama 35487 —
Cedars Sinai Los Angeles California 90048 —
Children's Hospital of Colorado Aurora Colorado 80045 —
Advocate Childrens Hospital Oak Lawn Illinois 60453 —
Boston Children's Hospital Boston Massachusetts 02115 —
Minneapolis Heart Minneapolis Minnesota 55407 —
St. Louis Children's Hospital St Louis Missouri 63110 —
Newark Beth Israel Medical Center Newark New Jersey 07112 —
Mount Sinai New York New York 10029 —
Columbia University Medical Center/NYPH New York New York 10032 —
Duke University Durham North Carolina 27710 —
Cincinatti Children's Hospital Cincinnati Ohio 45229 —
Nationwide Children's Hospital Columbus Ohio 43215 —
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104 —
University of Pittsburgh Medical Center Pittsburgh Pennsylvania 19146 —
Dell Children's Austin Texas 78723 —
Children's Health Dallas Dallas Texas 75235 —
Primary Children's Salt Lake City Utah 84108 —
University of Virginia Charlottesville Virginia 22908 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04860765, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 3, 2026 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04860765 live on ClinicalTrials.gov.

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