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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 : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Brief Summary:
The purpose of this study is to evaluate the hypothesis that valve dysfunction of the Edwards Lifesciences SAPIEN 3 Transcatheter Heart Valve (THV) System is within the performance goal of 25% 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 Conduits or Previously Implanted Valve in the Pulmonic Position Device: SAPIEN 3 THV Not Applicable

Detailed Description:
The purpose of this study is to demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3 THV System in subjects with a dysfunctional RVOT conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
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
Actual Primary Completion Date : July 17, 2018
Estimated Study Completion Date : December 2022


Arm Intervention/treatment
Experimental: TPVI
Transcatheter Pulmonary Valve Implantation with the SAPIEN 3 THV
Device: SAPIEN 3 THV
SAPIEN 3 THV in the pulmonic position




Primary Outcome Measures :
  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 [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Device Success [ Time Frame: Immediately 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.



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

Inclusion Criteria:

  • Weight ≥ 20 kg (44 lbs.)
  • 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.

Exclusion Criteria:

  • 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 (WBC < 2000 cells/µL), anemia (Hgb < 7 g/dL), thrombocytopenia (Platelets < 50,000 cells/µL) or any known blood clotting disorder
  • Inappropriate anatomy for femoral introduction and delivery of the SAPIEN 3 THV

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): NCT02744677


Contacts
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Contact: Veronica Pettigrew, RN 949-250-4116 Veronica_Pettigrew@Edwards.com
Contact: John Tejeda John_Tejeda@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

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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT02744677     History of Changes
Other Study ID Numbers: 2015-01
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
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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Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities