COMPASSION S3 Post-Approval Study

Pulmonary Valve Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04860765
• Other study ID #: 2020-07
• Status: Recruiting
• Start date: April 13, 2021
• Est. completion date: August 2030

Study information

• Verified date: March 2024
• Source: Edwards Lifesciences
• Contact: Edwards THV Clinical Affairs
• Phone: 949-250-2500
• Email: THV_CT.gov[@]Edwards.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 2030
• Est. primary completion date: August 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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 Conditions & MeSH terms

• Complex Congenital Heart Defect
• Dysfunctional RVOT Conduit
• Heart Defects, Congenital
• Pulmonary Valve Degeneration
• Pulmonary Valve Insufficiency

Intervention

Device:
• SAPIEN 3 THV
SAPIEN 3 THV in the pulmonic position

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Children's Hospital of Colorado	Aurora	Colorado
United States	Dell Children's	Austin	Texas
United States	University of Alabama	Birmingham	Alabama
United States	Boston Children's Hospital	Boston	Massachusetts
United States	University of Virginia	Charlottesville	Virginia
United States	Cincinatti Children's Hospital	Cincinnati	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Children's Health Dallas	Dallas	Texas
United States	Duke University	Durham	North Carolina
United States	Cedars Sinai	Los Angeles	California
United States	Minneapolis Heart	Minneapolis	Minnesota
United States	Columbia University Medical Center/NYPH	New York	New York
United States	Mount Sinai	New York	New York
United States	Newark Beth Israel Medical Center	Newark	New Jersey
United States	Advocate Childrens Hospital	Oak Lawn	Illinois
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	St. Louis Children's Hospital	Saint Louis	Missouri
United States	Primary Children's	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device Success	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