COMPASSION XT PAS - Post-approval Study of the SAPIEN XT THV in Patients With Pulmonary Valve Dysfunction

Active, not recruiting

• Conditions: Pulmonary Valve Insufficiency; Heart Defects, Congenital; Congenital Abnormalities; Heart Diseases; Pulmonary Valve Stenosis; Cardiovascular Diseases
• Interventions: Device: SAPIEN XT THV

• Registration Number: NCT02987387
• Lead Sponsor: Edwards Lifesciences

Brief Summary

This study will confirm the safety and effectiveness of the Edwards Lifesciences SAPIEN XT Transcatheter Heart Valve (THV) System in patients with a dysfunctional right ventricular outflow tract (RVOT) conduit with a clinical indication for intervention in a post-market setting.

Detailed Description

The study is a prospective, non-randomized, multi-center clinical study to assess the safety and effectiveness of pulmonic implantation of the SAPIEN THV in patients with dysfunctional RVOT conduits requiring treatment for moderate or severe pulmonary regurgitation (PR) by transthoracic echocardiography (TTE) and/or RVOT conduit obstruction with a mean gradient of ≥ 35 mmHg by TTE.

Study Timeline

• Study First Submitted: 2016-10-19
• Study First Submitted QC: 2016-12-06
• Study First Posted: 2016-12-08
• Study Start: 2017-07-17
• Primary Completion: 2021-08-09
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-27
• Last Update Posted: 2023-10-30
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

1. Patient has a dysfunctional, non-compliant RVOT conduit.
2. The patient/patient's legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria

1. Inability to tolerate an anticoagulation/antiplatelet regimen
2. Active bacterial endocarditis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TPVI	SAPIEN XT THV	Transcatheter Pulmonary Valve Implantation with the SAPIEN XT THV

Primary Outcome Measures

Name	Time	Method
Freedom from device- or procedure-related death or reintervention	1 year

Secondary Outcome Measures

Name	Time	Method
Decrease in RVOT mean gradient to less than 30 mmHg for stenotic lesions	1 year	Assessed via TTE
Decrease in pulmonary regurgitation to mild or less for regurgitant lesions	1 year	Assessed via transthoracic echocardiogram (TTE)
Device Success	48 Hours Prior to Discharge	Device Success is a composite of: * Deployment of the valve to the target area, and; * Removal of the delivery catheter out of the body, and; * Improvement in pulmonary regurgitation to mild or less per the earliest evaluable TTE.

Trial Locations

Locations (12)

Children's National Medical Center; 🇺🇸 Washington, District of Columbia, United States

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States

Children's Heart Center Nevada; 🇺🇸 Las Vegas, Nevada, United States

Children's Hospital of Pittsburgh of UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States

Newark Beth Israel Medical Center; 🇺🇸 Newark, New Jersey, United States

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States

Mount Sinai Beth Israel; 🇺🇸 New York, New York, United States

Advocate Children's Hospital; 🇺🇸 Oak Lawn, Illinois, United States

The University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

Children's Hospital of Michigan; 🇺🇸 Detroit, Michigan, United States