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

Cardiovascular Diseases Clinical Trial

Official title:

New Enrollment SAPIEN XT Post-Approval Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02987387
• Other study ID #: 2015-10
• Status: Active, not recruiting
• Start date: July 17, 2017
• Est. completion date: September 2025

Study information

• Verified date: October 2023
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 57
• Est. completion date: September 2025
• Est. primary completion date: August 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Congenital Abnormalities
• Heart Defects, Congenital
• Heart Diseases
• Pulmonary Valve Insufficiency
• Pulmonary Valve Stenosis

Intervention

Device:
• SAPIEN XT THV
SAPIEN XT THV will be implanted in the pulmonic position.

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado
United States	University of Alabama	Birmingham	Alabama
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Children's Hospital of Michigan	Detroit	Michigan
United States	The University of Iowa	Iowa City	Iowa
United States	Children's Heart Center Nevada	Las Vegas	Nevada
United States	Mount Sinai Beth Israel	New York	New York
United States	Newark Beth Israel Medical Center	Newark	New Jersey
United States	Advocate Children's Hospital	Oak Lawn	Illinois
United States	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from device- or procedure-related death or reintervention		1 year
Secondary	Decrease in pulmonary regurgitation to mild or less for regurgitant lesions	Assessed via transthoracic echocardiogram (TTE)	1 year
Secondary	Decrease in RVOT mean gradient to less than 30 mmHg for stenotic lesions	Assessed via TTE	1 year
Secondary	Device Success	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.	48 Hours Prior to Discharge