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

• Sponsor: Edwards Lifesciences (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02987387
• Collaborator: (none)
• Enrollment: 57
• Locations: 12
• Anticipated Duration (Months): 97.5
• Patients Per Site: 4.8
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Valve Insufficiency; Pulmonary Valve Stenosis; Heart Defects, Congenital; Congenital Abnormalities; Cardiovascular Diseases; Heart Diseases	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 Design

• Study Type: Observational
• Actual Enrollment: 57 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: New Enrollment SAPIEN XT Post-Approval Study
• Actual Study Start Date: Jul 17, 2017
• Actual Primary Completion Date: Aug 9, 2021
• Anticipated Study Completion Date: Sep 1, 2025

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Freedom from device- or procedure-related death or reintervention [1 year]

Secondary Outcome Measures

1. Decrease in pulmonary regurgitation to mild or less for regurgitant lesions [1 year]

   Assessed via transthoracic echocardiogram (TTE)

2. Decrease in RVOT mean gradient to less than 30 mmHg for stenotic lesions [1 year]

   Assessed via TTE

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama	Birmingham	Alabama	United States	35294
2	Children's Hospital Colorado	Aurora	Colorado	United States	80045
3	Children's National Medical Center	Washington	District of Columbia	United States	20010
4	Advocate Children's Hospital	Oak Lawn	Illinois	United States	60453
5	The University of Iowa	Iowa City	Iowa	United States	52242
6	Children's Hospital of Michigan	Detroit	Michigan	United States	48201
7	Children's Heart Center Nevada	Las Vegas	Nevada	United States	89109
8	Newark Beth Israel Medical Center	Newark	New Jersey	United States	07112
9	Mount Sinai Beth Israel	New York	New York	United States	10003
10	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
11	Nationwide Children's Hospital	Columbus	Ohio	United States	43205
12	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania	United States	15224

Sponsors and Collaborators

• Edwards Lifesciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Edwards Lifesciences
• ClinicalTrials.gov Identifier: NCT02987387
• Other Study ID Numbers: 2015-10
• First Posted: Dec 8, 2016
• Last Update Posted: Oct 12, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Edwards Lifesciences: Tetralogy of Fallot; Aortic Valve Defect/Disease Resulting in Ross Procedure; Transcatheter pulmonary valve implantation; Transcatheter pulmonary valve replacement; Pulmonary Atresia; Pulmonary Stenosis
• Additional relevant MeSH terms: Cardiovascular Diseases; Heart Diseases; Heart Defects, Congenital; Pulmonary Valve Insufficiency; Pulmonary Valve Stenosis; Congenital Abnormalities

Study Results

No Results Posted as of Oct 12, 2021