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

NCT02744677 | Recruiting DMC FDA Device

• 1 other identifier: 2015-01
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 25

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.

Conditions

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

Keywords

Tetralogy of Fallot; Aortic Valve Defect/Disease Resulting in Ross Procedure; Pulmonary Atresia; Pulmonary Stenosis; Truncus Arteriosus; Transposition of the Great Arteries; Transcatheter pulmonary valve implantation; Transcatheter pulmonary valve replacement; TPV; TPVR; TPVI

Outcome Measures

Primary Outcomes (1)

• THV dysfunction

  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

  1 year

Secondary Outcomes (10)

• Device Success

  Discharge, expected to be within 1-5 days post-procedure

• Mean RVOT gradient

  6 months

• Paravalvular and total PR

  6 months

• RVOT reintervention

  6 months

• Coronary artery compression requiring intervention

  30 days

Study Arms (3)

TPVR - Main Cohort

EXPERIMENTAL

Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position will undergo transcatheter pulmonary valve replacement (TPVR).

Device: SAPIEN 3 THV

TPVR - THV Registry

EXPERIMENTAL

Subjects with a previously implanted transcatheter valve in the pulmonic position will undergo TPVR.

Device: SAPIEN 3/SAPIEN 3 Ultra RESILIA THV

TPVR- S3UR Registry

EXPERIMENTAL

Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position will undergo transcatheter pulmonary valve replacement (TPVR).

Device: SAPIEN 3 Ultra RESILIA THV

Interventions

SAPIEN 3 THV DEVICE

SAPIEN 3 THV in the pulmonic position

TPVR - Main Cohort

SAPIEN 3 Ultra RESILIA THV DEVICE

SAPIEN 3 Ultra RESILIA THV in the pulmonic position

TPVR- S3UR Registry

SAPIEN 3/SAPIEN 3 Ultra RESILIA THV DEVICE

SAPIEN 3/SAPIEN 3 Ultra RESILIA THV in the pulmonic position

TPVR - THV Registry

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Weight ≥ 20 kg (44 lbs.)
• 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
• Subject presents with at least moderate PR and/or mean RVOT gradient ≥ 35 mmHg.
• 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.

You may not qualify if:

• Active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 2 weeks after discontinuation of antibiotics)
• History of or active endocarditis (active treatment with antibiotics) within the past 180 days
• Leukopenia, anemia, thrombocytopenia or any known blood clotting disorder
• Inappropriate anatomy for femoral introduction and delivery of the study valve
• 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
• Angiographic evidence of coronary artery compression that would result from transcatheter pulmonic valve implantation (TPVI)
• Interventional/surgical procedures within 30 days prior to the TPVI procedure.
• Any planned surgical, percutaneous coronary or peripheral procedure to be performed within the 30 day follow-up from the TPVI procedure.
• History of or current intravenous drug use
• Major or progressive non-cardiac disease resulting in a life expectancy of less than one year
• Known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and/or antithrombotic medications
• Known hypersensitivity to cobalt-chromium, nickel or contrast media that cannot be adequately premedicated
• Participating in another investigational drug or device study that has not reached its primary endpoint.
• Female who is lactating or pregnant

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (25)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

RECRUITING

University of California, Los Angeles

Los Angeles, California, 90095, United States

COMPLETED

University of California,, San Francisco (UCSF)

San Francisco, California, 94143, United States

RECRUITING

Childrens Hospital of Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Emory University/Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

RECRUITING

University of Kentucky

Lexington, Kentucky, 40536, United States

WITHDRAWN

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

RECRUITING

Washington University Barnes- Jewish Medical/ St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

COMPLETED

Columbia University Medical Center/NYPH

New York, New York, 10032, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

The Lindner Research Center at Christ Hospital

Cincinnati, Ohio, 45219, United States

COMPLETED

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

Penn Presbyterian Medical Center, University of Pennsylvania/ Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

COMPLETED

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

RECRUITING

LeBonheur Children's Hopsital

Memphis, Tennessee, 38103, United States

RECRUITING

Medical City Dallas

Dallas, Texas, 75230, United States

RECRUITING

Children's Health System of Texas / UT Southwestern Medical Center

Dallas, Texas, 75235, United States

RECRUITING

Methodist San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Intermountain Heart Institute (IMC)

Murray, Utah, 84107, United States

RECRUITING

University of Virginia (UVA)

Charlottesville, Virginia, 22908, United States

RECRUITING

University of Washington/Seattle Children's Hospital

Seattle, Washington, 98195, United States

COMPLETED

Related Publications (2)

• Lim DS, Kim D, Aboulhosn J, Levi D, Fleming G, Hainstock M, Sommer R, Torres AJ, Zhao Y, Shirali G, Babaliaros V. Congenital Pulmonic Valve Dysfunction Treated With SAPIEN 3 Transcatheter Heart Valve (from the COMPASSION S3 Trial). Am J Cardiol. 2023 Mar 1;190:102-109. doi: 10.1016/j.amjcard.2022.12.010. Epub 2023 Jan 4.

  PMID: 36608435 BACKGROUND

• Hainstock MR, Fleming G, Kim D, Aboulhosn J, Levi D, Krasuski R, Sommer R, Torres AJ, Gray R, Kereiakes D, Leventhal A, Gillespie M, Szeto W, Zajarias A, Shahanavaz S, Steinberg ZL, Jones TK, Mahadevan VS, Moore P, Elmariah S, Shirali G, Li W, Babaliaros V, Lim DS; COMPASSION 3 Trial Executive Committee and Study Investigators. Five-Year Outcomes for Patients With RVOT Dysfunction Treated With the SAPIEN 3 Transcatheter Heart Valve: A Pooled Analysis From the COMPASSION S3 Trial. Circ Cardiovasc Interv. 2026 Mar 26:e016361. doi: 10.1161/CIRCINTERVENTIONS.125.016361. Online ahead of print.

  PMID: 41884901 DERIVED

MeSH Terms

Conditions

Pulmonary Valve Insufficiency; Tetralogy of Fallot; Aortic Valve Disease; Pulmonary Atresia; Pulmonary Valve Stenosis; Truncus Arteriosus, Persistent; Transposition of Great Vessels

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Vascular Malformations; Ventricular Outflow Obstruction; Aortopulmonary Septal Defect; Heart Septal Defects

Study Officials

• D. Scott Lim, MD

  University of Virginia Medical Center

  PRINCIPAL INVESTIGATOR

• Vasilis Babaliaros, MD

  Emory University Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edwards THV Clinical Affairs

CONTACT

(949) 250-2500; THV_CT.gov@Edwards.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2016
• First Posted: April 20, 2016
• Study Start: July 5, 2016
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2031
• Last Updated: March 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (25)