COMPASSION S3 Post-Approval Study

N/AActive Not RecruitingNCT04860765

Edwards Lifesciences150 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

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

Interventions

SAPIEN 3 THVDEVICE

SAPIEN 3 THV in the pulmonic position

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (19)

University of Alabama

Birmingham, Alabama, United States

Cedars Sinai

Los Angeles, California, United States

Outcomes

Primary Outcomes

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

Time frame: Discharge, expected to be within 1-5 days post-procedure

Data from ClinicalTrials.gov

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