About Pricing FAQs Blog

Loading clinical trials...

Your health journey, clearly organized.

Find Clinical Trials →

Legal

Privacy Policy
Terms of Service

© 2026 Clareo Health. All rights reserved.

COMPASSION S3 Post-Approval Study | Clinical Trials | Clareo Health

Back to clinical trial search

Active Not RecruitingNCT04860765

COMPASSION S3 Post-Approval Study

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 previo...

Lead sponsor: Edwards Lifesciences•19 U.S. locations•View source on ClinicalTrials.gov

Clareo plain-language summary

What this study is about

Generating AI summary...

Clareo turns complex medical information into clear understanding you can use.

Bring this clarity to your next appointment.

Keep all your medical notes and next steps in one place.

Sponsors

Lead Sponsor

Edwards Lifesciences

This is a single arm, prospective, multicenter post-approval study.

Age

All ages

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•1. Dysfunctional RVOT conduit or previously implanted surgical valve
•2. RVOT/PV with ≥ moderate regurgitation and/or a mean RVOT/PV gradient of ≥ 35 mmHg

Exclusion Criteria

•1. Inability to tolerate an anticoagulation/antiplatelet regimen
•2. Active bacterial endocarditis or other active infections

Related studies

COMMENCE Pulmonary: Clinical Evaluation of Edwards Pericardial Aortic Bioprosthesis (Model 11000A) for Pulmonary Valve Replacement

NCT02656290 · Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration, and more

A Feasibility Study to Evaluate the Safety and Short-term Effectiveness of Transcatheter Pulmonary Valve (TPV)

NCT02555319 · Congenital Heart Defects, Cardiovascular Abnormalities, and more

Comparison of Two Pulmonary Valve Replacement Methods to Treat Tetralogy of Fallot

NCT00112320 · Tetralogy of Fallot, Pulmonary Valve Insufficiency, and more

COMPLETEDPhase 3

Pulmonary Valve Replacement in Large Right Ventricular Outflow Tract

NCT00259207 · Pulmonary Valve Insufficiency

Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: February 3, 2026Terms

Trial snapshot

StatusACTIVE_NOT_RECRUITING

Phase—

Enrollment150

Start dateApr 2021

Last updatedFeb 3, 2026

Condition

Complex Congenital Heart Defect Dysfunctional RVOT Conduit Pulmonary Valve Insufficiency Pulmonary Valve Degeneration Pulmonary Valve; Obstruction

Locations shown

University of Alabama

Birmingham, Alabama

Cedars Sinai

Los Angeles, California

Children's Hospital of Colorado

Aurora, Colorado

For caregivers

Use Clareo to keep notes, questions, trial details, and next steps organized before and after appointments.

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 3, 2026Data synced to Clareo: April 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions