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

COngenital Multicenter Trial of Pulmonic vAlve Dysfunction Studying the SAPIEN 3 interventIONal THV

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Valve Insufficiency; Complex Congenital Heart Defect; Dysfunctional RVOT Conduit; Pulmonary Valve Degeneration
• Intervention / Treatment: Device: SAPIEN 3 THV; Device: SAPIEN 3/SAPIEN 3 Ultra RESILIA THV; Device: SAPIEN 3 Ultra RESILIA THV

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Edwards THV Clinical Affairs; Phone Number: (949) 250-2500; Email: THV_CT.gov@Edwards.com

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Recruiting
      • Arkansas Children's Hospital
  • California
    • Los Angeles, California, United States, 90095
      • Recruiting
      • University of California, Los Angeles
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California,, San Francisco (UCSF)
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • Childrens Hospital of Colorado
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University/Children's Healthcare of Atlanta
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • Withdrawn
      • University of Kentucky
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Boston Children's Hospital
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • St. Louis Children's Hospital
    • Saint Louis, Missouri, United States, 63110
      • Completed
      • Washington University Barnes- Jewish Medical/ St. Louis Children's Hospital
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Medical Center/NYPH
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Recruiting
      • Cincinnati Children's Hospital
    • Cincinnati, Ohio, United States, 45219
      • Recruiting
      • The Lindner Research Center at Christ Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Penn Presbyterian Medical Center, University of Pennsylvania/ Children's Hospital of Philadelphia
  • Tennessee
    • Memphis, Tennessee, United States, 38103
      • Recruiting
      • LeBonheur Children's Hopsital
  • Texas
    • Dallas, Texas, United States, 75235
      • Recruiting
      • Children's Health System of Texas / UT Southwestern Medical Center
  • Utah
    • Murray, Utah, United States, 84107
      • Recruiting
      • Intermountain Heart Institute (IMC)
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Recruiting
      • University of Virginia (UVA)
  • Washington
    • Seattle, Washington, United States, 98195
      • Recruiting
      • University of Washington/Seattle Children's Hospital

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TPVR - Main Cohort; 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; SAPIEN 3 THV in the pulmonic position
Experimental: TPVR - THV Registry; Subjects with a previously implanted transcatheter valve in the pulmonic position will undergo TPVR.	Device: SAPIEN 3/SAPIEN 3 Ultra RESILIA THV; SAPIEN 3/SAPIEN 3 Ultra RESILIA THV in the pulmonic position
Experimental: TPVR- S3UR Registry; 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; SAPIEN 3 Ultra RESILIA THV in the pulmonic position

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major vascular complications		30 days
Device Success	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.	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
THV frame fracture		6 months
Device-related endocarditis		1 year
Death (all-cause, procedural and device-related)		1 year
Life-threatening or disabling bleeding		30 days

Collaborators and Investigators

• Sponsor: Edwards Lifesciences
• Investigators: Principal Investigator: D. Scott Lim, MD, University of Virginia Medical Center; Principal Investigator: Vasilis Babaliaros, MD, Emory University Hospitals

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2016
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2031

Study Registration Dates

• First Submitted: April 12, 2016
• First Submitted That Met QC Criteria: April 15, 2016
• First Posted (Estimated): April 20, 2016

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

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; Transposition of the Great Arteries; TPV; Truncus Arteriosus; TPVR; TPVI
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Valve Diseases; Cardiovascular Abnormalities; Heart Defects, Congenital; Pulmonary Valve Insufficiency
• Other Study ID Numbers: 2015-01

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