Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT02744677
Recruitment Status : Recruiting
First Posted : April 20, 2016
Last Update Posted : March 16, 2021
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 March 16, 2021
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: March 12, 2021)
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
Original 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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2021)
  • 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.
  • Mean RVOT gradient [ Time Frame: 6 months ]
  • Paravalvular and total PR [ Time Frame: 6 months ]
  • RVOT reintervention [ Time Frame: 6 months ]
  • Coronary artery compression requiring intervention [ Time Frame: 30 days ]
  • Major vascular complications [ 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 ]
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 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Complex Congenital Heart Defect
  • Dysfunctional RVOT Conduit
  • Pulmonary Valve Insufficiency
  • Pulmonary Valve Degeneration
Intervention  ICMJE Device: SAPIEN 3 THV
SAPIEN 3 THV in the pulmonic position
Study Arms  ICMJE
  • 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).
    Intervention: Device: SAPIEN 3 THV
  • Experimental: TPVR - THV Registry
    Subjects with a previously implanted transcatheter valve in the pulmonic position will undergo TPVR.
    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:

  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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Edwards THV Clinical Affairs (949) 250-2500 THV_CT.gov@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: No
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 March 2021

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