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NCT04860765 | RECRUITING | Complex Congenital Heart Defect

COMPASSION S3 Post-Approval Study
Sponsor:

Edwards Lifesciences

Brief Summary:

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.

Condition or disease

Complex Congenital Heart Defect

Dysfunctional RVOT Conduit

Pulmonary Valve Insufficiency

Pulmonary Valve Degeneration

Pulmonary Valve; Obstruction

Intervention/treatment

SAPIEN 3 THV

Detailed Description:

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

Study Type : OBSERVATIONAL
Estimated Enrollment : 150 participants
Official Title : Congenital Multicenter Trial of Pulmonic Valve Dysfunction Studying the SAPIEN 3 Interventional THV Post-Approval Study
Actual Study Start Date : 2021-04-13
Estimated Primary Completion Date : 2030-08
Estimated Study Completion Date : 2030-08

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
COMPASSION S3 Post-Approval Study

Location Details

NCT04860765

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, alabama

University of Alabama

Birmingham, alabama, United States, 35487

RECRUITING

United States, California

Cedars Sinai

Los Angeles, California, United States, 90048

RECRUITING

United States, Colorado

Children's Hospital of Colorado

Aurora, Colorado, United States, 80045

WITHDRAWN

United States, Georgia

Emory University

Atlanta, Georgia, United States, 30308

RECRUITING

United States, Illinois

Advocate Childrens Hospital

Oak Lawn, Illinois, United States, 60453

RECRUITING

United States, Massachusetts

Boston Children's Hospital

Boston, Massachusetts, United States, 02115

RECRUITING

United States, Minnesota

Minneapolis Heart

Minneapolis, Minnesota, United States, 55407

RECRUITING

United States, Missouri

St. Louis Children's Hospital

St. Louis, Missouri, United States, 63110

RECRUITING

United States, New Jersey

Newark Beth Israel Medical Center

Newark, New Jersey, United States, 07112

RECRUITING

United States, New York

Mount Sinai

New York, New York, United States, 10029

RECRUITING

United States, New York

Columbia University Medical Center/NYPH

New York, New York, United States, 10032

RECRUITING

United States, North Carolina

Duke University

Durham, North Carolina, United States, 27710

RECRUITING

United States, Ohio

Cincinatti Children's Hospital

Cincinnati, Ohio, United States, 45229

RECRUITING

United States, Ohio

Nationwide Children's Hospital

Columbus, Ohio, United States, 43215

RECRUITING

United States, Pennsylvania

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

RECRUITING

United States, Pennsylvania

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 19146

RECRUITING

United States, Texas

Dell Children's

Austin, Texas, United States, 78723

RECRUITING

United States, Texas

Children's Health Dallas

dallas, Texas, United States, 75235

RECRUITING

United States, Utah

Primary Children's

Salt Lake City, Utah, United States, 84108

RECRUITING

United States, Virginia

University of Virginia

Charlottesville, Virginia, United States, 22908