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COMPASSION S3 Post-Approval Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04860765
Recruitment Status : Recruiting
First Posted : April 27, 2021
Last Update Posted : March 11, 2022
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Study Description
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Brief Summary:
This study will monitor device performance and outcomes of the SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted surgical valve in the pulmonic position with a clinical indication for intervention.

Condition or disease Intervention/treatment
Complex Congenital Heart Defect Dysfunctional RVOT Conduit Pulmonary Valve Insufficiency Pulmonary Valve Degeneration Pulmonary Valve; Obstruction Device: SAPIEN 3 THV

Detailed Description:
This is a single arm, prospective, multicenter post-approval study.
Study Design
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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Congenital Multicenter Trial of Pulmonic Valve Dysfunction Studying the SAPIEN 3 Interventional THV Post-Approval Study
Actual Study Start Date : April 13, 2021
Estimated Primary Completion Date : August 2030
Estimated Study Completion Date : August 2030
Groups and Cohorts
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Group/Cohort Intervention/treatment
TPVR
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


Outcome Measures
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Primary Outcome Measures :
  1. Device Success [ Time Frame: Discharge, expected to be within 1-5 days post-procedure ]

    Defined as a composite of:

    • Single THV implanted in the desired location
    • Right ventricle to pulmonary artery peak-to-peak gradient < 35 mmHg post-implantation
    • Less than moderate PR by discharge TTE
    • Free of explant at 24 hours post-implantation


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position with a clinical indication for intervention
Criteria

Inclusion Criteria:

  1. Dysfunctional RVOT conduit or previously implanted surgical valve
  2. RVOT/PV with ≥ moderate regurgitation and/or a mean RVOT/PV gradient of ≥ 35 mmHg

Exclusion Criteria:

  1. Inability to tolerate an anticoagulation/antiplatelet regimen
  2. Active bacterial endocarditis or other active infections
Contacts and Locations
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Information from the National Library of Medicine

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): NCT04860765


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, Alabama
University of Alabama Recruiting
Birmingham, Alabama, United States, 35487
United States, California
Cedars Sinai Recruiting
Los Angeles, California, United States, 90048
United States, Colorado
Children's Hospital of Colorado Recruiting
Aurora, Colorado, United States, 80045
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30308
United States, Illinois
Advocate Childrens Hospital Recruiting
Oak Lawn, Illinois, United States, 60453
United States, Minnesota
Minneapolis Heart Recruiting
Minneapolis, Minnesota, United States, 55407
United States, Missouri
St. Louis Children's Hospital Recruiting
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Newark Beth Israel Medical Center Recruiting
Newark, New Jersey, United States, 07112
United States, New York
Mount Sinai Recruiting
New York, New York, United States, 10029
Columbia University Medical Center/NYPH Recruiting
New York, New York, United States, 10032
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
United States, Ohio
Cincinatti Children's Hospital Recruiting
Cincinnati, Ohio, United States, 45229
United States, Texas
Children's Health Dallas Recruiting
Dallas, Texas, United States, 75235
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Edwards Lifesciences
More Information
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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT04860765    
Other Study ID Numbers: 2020-07
First Posted: April 27, 2021    Key Record Dates
Last Update Posted: March 11, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Product Manufactured in and Exported from the U.S.: No
Keywords provided by Edwards Lifesciences:
Transcatheter pulmonary valve replacement
Transcatheter pulmonary valve implantation
SAPIEN 3
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