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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 : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Tracking Information
First Submitted Date  ICMJE April 12, 2016
First Posted Date  ICMJE April 20, 2016
Last Update Posted Date February 5, 2020
Actual Study Start Date  ICMJE July 5, 2016
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2016)		 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2017)		 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2016)
  • 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.
  • Mean RVOT gradient via TTE [ Time Frame: 6 months ]
  • Paravalvular and total PR via TTE [ Time Frame: 6 months ]
  • RVOT reintervention [ Time Frame: 6 months ]
  • Coronary artery compression requiring intervention [ Time Frame: Post-implantation through 30 days ]
  • Major Vascular Complications [ Time Frame: 30 days ]
  • Life-threatening or disabling bleeding [ Time Frame: 30 days ]
  • THV frame fracture [ Time Frame: 6 months ]
  • Device-related endocarditis [ Time Frame: 1 year ]
  • Death (all-cause, procedural and device-related) [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
Official Title  ICMJE COngenital Multicenter Trial of Pulmonic vAlve Dysfunction Studying the SAPIEN 3 interventIONal THV
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.
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. In addition patients with dysfunctional THV will be enrolled in a separate registry.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Complex Congenital Heart Defect
  • Dysfunctional RVOT Conduits or Previously Implanted Valve in the Pulmonic Position
Intervention  ICMJE Device: SAPIEN 3 THV
SAPIEN 3 THV in the pulmonic position
Study Arms  ICMJE Experimental: TPVI
Transcatheter Pulmonary Valve Implantation with the SAPIEN 3 THV
Intervention: Device: SAPIEN 3 THV
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 31, 2020)		 108
Original Estimated Enrollment  ICMJE
 (submitted: April 15, 2016)		 58
Estimated Study Completion Date  ICMJE December 2027
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Veronica Pettigrew, RN 949-250-4116 Veronica_Pettigrew@Edwards.com
Contact: John Tejeda John_Tejeda@Edwards.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02744677
Other Study ID Numbers  ICMJE 2015-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Edwards Lifesciences
Study Sponsor  ICMJE Edwards Lifesciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: D. Scott Lim, MD University of Virginia Medical Center
Principal Investigator: Vasilis Babaliaros, MD Emory University Hospitals
PRS Account Edwards Lifesciences
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP