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

New Enrollment SAPIEN XT Post-Approval Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Pulmonary Valve Insufficiency; Pulmonary Valve Stenosis
• Intervention / Treatment: Device: SAPIEN XT THV

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 Type: Observational
• Enrollment (Actual): 57

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University Of Alabama
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Children's National Medical Center
  • Illinois
    • Oak Lawn, Illinois, United States, 60453
      • Advocate Children's Hospital
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • The University of Iowa
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Children's Hospital of Michigan
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Children's Heart Center Nevada
  • New Jersey
    • Newark, New Jersey, United States, 07112
      • Newark Beth Israel Medical Center
  • New York
    • New York, New York, United States, 10003
      • Mount Sinai Beth Israel
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • Children's Hospital of Pittsburgh of UPMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pediatric and adult patients with a dysfunctional, non-compliant right ventricular outflow tract (RVOT) conduit with a clinical indication for intervention.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TPVI; Transcatheter Pulmonary Valve Implantation with the SAPIEN XT THV	Device: SAPIEN XT THV; SAPIEN XT THV will be implanted in the pulmonic position.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Freedom from device- or procedure-related death or reintervention	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease in pulmonary regurgitation to mild or less for regurgitant lesions	Assessed via transthoracic echocardiogram (TTE)	1 year
Decrease in RVOT mean gradient to less than 30 mmHg for stenotic lesions	Assessed via TTE	1 year
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

Collaborators and Investigators

• Sponsor: Edwards Lifesciences

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2017
• Primary Completion (Actual): August 9, 2021
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: October 19, 2016
• First Submitted That Met QC Criteria: December 6, 2016
• First Posted (Estimated): December 8, 2016

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Pulmonary Stenosis; Tetralogy of Fallot; Transcatheter pulmonary valve replacement; Transcatheter pulmonary valve implantation; Aortic Valve Defect/Disease Resulting in Ross Procedure; Pulmonary Atresia
• Additional Relevant MeSH Terms: Heart Valve Diseases; Ventricular Outflow Obstruction; Cardiovascular Abnormalities; Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Pulmonary Valve Insufficiency; Pulmonary Valve Stenosis
• Other Study ID Numbers: 2015-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes