COMPASSION S3 Post-Approval Study

March 12, 2024 updated by: Edwards Lifesciences

Congenital Multicenter Trial of Pulmonic Valve Dysfunction Studying the SAPIEN 3 Interventional THV 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 previously implanted surgical valve in the pulmonic position with a clinical indication for intervention.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35487
        • Recruiting
        • University Of Alabama
    • California
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars Sinai
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Children's Hospital of Colorado
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Withdrawn
        • Emory University
    • Illinois
      • Oak Lawn, Illinois, United States, 60453
        • Recruiting
        • Advocate Childrens Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Boston Children's Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Minneapolis Heart
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • St. Louis Children's Hospital
    • New Jersey
      • Newark, New Jersey, United States, 07112
        • Recruiting
        • Newark Beth Israel Medical Center
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center/NYPH
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinatti Children's Hospital
      • Columbus, Ohio, United States, 43215
        • Recruiting
        • Nationwide Children's Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Children's Hospital of Philadelphia
      • Pittsburgh, Pennsylvania, United States, 19146
        • Recruiting
        • University of Pittsburgh Medical Center
    • Texas
      • Austin, Texas, United States, 78723
        • Recruiting
        • Dell Children's
      • Dallas, Texas, United States, 75235
        • Recruiting
        • Children's Health Dallas
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Recruiting
        • Primary Children's
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position with a clinical indication for intervention

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TPVR
Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position will undergo transcatheter pulmonary valve replacement (TPVR).
Device: SAPIEN 3 THV
SAPIEN 3 THV in the pulmonic position

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device Success
Time Frame: Discharge, expected to be within 1-5 days post-procedure

Defined as a composite of:

  • Single THV implanted in the desired location
  • Right ventricle to pulmonary artery peak-to-peak gradient < 35 mmHg post-implantation
  • Less than moderate PR by discharge TTE
  • Free of explant at 24 hours post-implantation
Discharge, expected to be within 1-5 days post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Edwards Lifesciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2021

Primary Completion (Estimated)

August 1, 2030

Study Completion (Estimated)

August 1, 2030

Study Registration Dates

First Submitted

April 23, 2021

First Submitted That Met QC Criteria

April 23, 2021

First Posted (Actual)

April 27, 2021

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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