COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction

Not Applicable

Recruiting

• Conditions: Complex Congenital Heart Defect; Dysfunctional RVOT Conduit; Pulmonary Valve Degeneration; Pulmonary Valve Insufficiency

• Registration Number: NCT02744677
• Lead Sponsor: Edwards Lifesciences

Brief Summary

This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-12
• Study First Submitted QC: 2016-04-15
• Study First Posted: 2016-04-20
• Study Start: 2016-07-05
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-18
• Primary Completion: 2026-12
• Study Completion: 2031-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

1. Weight ≥ 20 kg (44 lbs.)
2. Dysfunctional RVOT conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention and with a landing zone diameter ≥ 16.5 mm and ≤ 29 mm immediately prior to study device insertion as per the Instructions for Use
3. Subject presents with at least moderate PR and/or mean RVOT gradient ≥ 35 mmHg.
4. The subject/subject'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. Active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 2 weeks after discontinuation of antibiotics)
2. History of or active endocarditis (active treatment with antibiotics) within the past 180 days
3. Leukopenia, anemia, thrombocytopenia or any known blood clotting disorder
4. Inappropriate anatomy for femoral introduction and delivery of the study valve
5. Need for concomitant atrial septal defect or ventricular septal defect closure or other concomitant interventional procedures other than pulmonary artery or branch pulmonary artery stenting or angioplasty
6. Angiographic evidence of coronary artery compression that would result from transcatheter pulmonic valve implantation (TPVI)
7. Interventional/surgical procedures within 30 days prior to the TPVI procedure.
8. Any planned surgical, percutaneous coronary or peripheral procedure to be performed within the 30 day follow-up from the TPVI procedure.
9. History of or current intravenous drug use
10. Major or progressive non-cardiac disease resulting in a life expectancy of less than one year
11. Known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and/or antithrombotic medications
12. Known hypersensitivity to cobalt-chromium, nickel or contrast media that cannot be adequately premedicated
13. Participating in another investigational drug or device study that has not reached its primary endpoint.
14. Female who is lactating or pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
THV dysfunction	1 year	Defined as a non-hierarchical composite of: RVOT reintervention, Moderate or greater total pulmonary regurgitation (PR) via Transthoracic Echocardiography (TTE), Mean RVOT gradient \> 40 mmHg via TTE

Secondary Outcome Measures

Name	Time	Method
THV frame fracture	6 months
Device Success	Discharge, expected to be within 1-5 days post-procedure	Defined as a composite of: 1) Single THV implanted in the desired location, 2) RV-PA peak-to-peak gradient \< 35 mmHg post-implantation, 3) Less than moderate PR by discharge TTE (or earliest evaluable TTE), 4) Free of explant at 24 hours post-implantation.
Paravalvular and total PR	6 months
RVOT reintervention	6 months
Mean RVOT gradient	6 months
Major vascular complications	30 days
Life-threatening or disabling bleeding	30 days
Device-related endocarditis	1 year
Death (all-cause, procedural and device-related)	1 year
Coronary artery compression requiring intervention	30 days

Trial Locations

Locations (25)

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

Arkansas Children's Hospital; 🇺🇸 Little Rock, Arkansas, United States

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States

University of California,, San Francisco (UCSF); 🇺🇸 San Francisco, California, United States

Childrens Hospital of Colorado; 🇺🇸 Aurora, Colorado, United States

Emory University/Children's Healthcare of Atlanta; 🇺🇸 Atlanta, Georgia, United States

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States

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