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

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ClinicalTrials.gov Identifier: NCT02744677
Recruitment Status : Recruiting
First Posted : April 20, 2016
Last Update Posted : March 16, 2021
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Study Description
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Brief Summary:
This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3 Transcatheter Heart Valve (THV) System 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.

Condition or disease Intervention/treatment Phase
Complex Congenital Heart Defect Dysfunctional RVOT Conduit Pulmonary Valve Insufficiency Pulmonary Valve Degeneration Device: SAPIEN 3 THV Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: COngenital Multicenter Trial of Pulmonic vAlve Dysfunction Studying the SAPIEN 3 interventIONal THV
Actual Study Start Date : July 5, 2016
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : December 2027

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Arms and Interventions
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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 THV
SAPIEN 3 THV in the pulmonic position


Outcome Measures
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Primary Outcome Measures :
  1. THV dysfunction [ Time Frame: 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 :
  1. Device Success [ Time Frame: 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.

  2. Mean RVOT gradient [ Time Frame: 6 months ]
  3. Paravalvular and total PR [ Time Frame: 6 months ]
  4. RVOT reintervention [ Time Frame: 6 months ]
  5. Coronary artery compression requiring intervention [ Time Frame: 30 days ]
  6. Major vascular complications [ Time Frame: 30 days ]
  7. THV frame fracture [ Time Frame: 6 months ]
  8. Device-related endocarditis [ Time Frame: 1 year ]
  9. Death (all-cause, procedural and device-related) [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 SAPIEN 3 THV
  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. Emergency 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. Currently participating in an investigational drug or another device study.
  14. Positive urine or serum pregnancy test in female subjects of child-bearing potential
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02744677


Contacts
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Contact: Edwards THV Clinical Affairs (949) 250-2500 THV_CT.gov@Edwards.com

Locations
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United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
University of California,, San Francisco (UCSF) Recruiting
San Francisco, California, United States, 94143
United States, Georgia
Emory University/Children's Healthcare of Atlanta Recruiting
Atlanta, Georgia, United States, 30322
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
United States, Missouri
Washington University Barnes- Jewish Medical/ St. Louis Children's Hospital Recruiting
Saint Louis, Missouri, United States, 63110
United States, New York
Columbia University Medical Center/New York - Presbyterian Morgan Stanley Children's Hospital Recruiting
New York, New York, United States, 10032
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
United States, Ohio
The Lindner Research Center at Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
United States, Pennsylvania
Penn Presbyterian Medical Center, University of Pennsylvania/ Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Utah
Intermountain Heart Institute (IMC) Recruiting
Murray, Utah, United States, 84107
United States, Virginia
University of Virginia (UVA) Recruiting
Charlottesville, Virginia, United States, 22908
United States, Washington
University of Washington/Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Edwards Lifesciences
Investigators
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Principal Investigator: D. Scott Lim, MD University of Virginia Medical Center
Principal Investigator: Vasilis Babaliaros, MD Emory University Hospitals
More Information
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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT02744677    
Other Study ID Numbers: 2015-01
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: March 16, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Edwards Lifesciences:
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
Additional relevant MeSH terms:
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Respiratory Insufficiency
Heart Defects, Congenital
Pulmonary Valve Insufficiency
Cardiovascular Abnormalities
Cardiovascular Diseases
 Heart Diseases
Congenital Abnormalities
Heart Valve Diseases
Respiration Disorders
Respiratory Tract Diseases