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The PARTNER 3 - Trial - The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis (P3)

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ClinicalTrials.gov Identifier: NCT02675114
Recruitment Status : Recruiting
First Posted : February 5, 2016
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Tracking Information
First Submitted Date  ICMJE January 22, 2016
First Posted Date  ICMJE February 5, 2016
Last Update Posted Date August 2, 2019
Actual Study Start Date  ICMJE March 2016
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2018)
All-cause mortality, all stroke, and re-hospitalization [ Time Frame: 1 year post procedure ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 2, 2016)
All-cause mortality, all stroke, and re-hospitalization [ Time Frame: 1 year post procedure ]
This composite endpoint will be evaluated as a non-inferiority analysis based on a relative non-inferiority margin of 35%
Change History Complete list of historical versions of study NCT02675114 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2016)
  • Length of index hospitalization (Device and Control group) [ Time Frame: Number of days from index procedure to discharge (expected average of 7 days) ]
  • Death or Stroke [ Time Frame: 30 Days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2016)
  • New onset atrial fibrillation [ Time Frame: 30 Days ]
  • Length of index hospitalization (Device and Control group) [ Time Frame: Number of days from index procedure to discharge (expected average of 7 days) ]
  • Death, KCCQ < 45 or KCCQ decrease ≥ 10 points [ Time Frame: 30 days ]
    Kansas City Cardiomyopathy Questionnaire (KCCQ) is used to assess quality of life measure for heart failure.
  • Death or Stroke [ Time Frame: 30 Days ]
  • Stroke (disabling and non-disabling) [ Time Frame: 30 Days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The PARTNER 3 - Trial - The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis
Official Title  ICMJE A Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients Who Have Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement
Brief Summary To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement (AVR).
Detailed Description

Prospective, randomized, controlled, multi-center trial. Patients having an operative mortality < 4% (low operative risk) for surgical aortic valve replacement will be randomized 1:1 to receive either transcatheter heart valve replacement (TAVR) with the Edwards SAPIEN 3 or aortic valve replacement with a commercially available surgical bioprosthetic valve. Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 10 years.

A subset of PARTNER 3 randomized patients will be enrolled in the Actigraphy/QOL. Additional patients will be enrolled in either the Bicuspid Registry, Underrepresented Populations Registry (UPR) or the Alternative Access Registry.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Aortic Stenosis
Intervention  ICMJE
  • Procedure: Surgical aortic valve replacement (SAVR)
    SAVR with a commercially available bioprosthetic valve.
    Other Name: SAVR
  • Device: Transcatheter Aortic Valve Replacement (TAVR)
    TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve and Edwards Commander Delivery System
    Other Names:
    • TAVR
    • TAVI
Study Arms  ICMJE
  • Active Comparator: Surgical aortic valve replacement (SAVR)
    Intervention: Procedure: Surgical aortic valve replacement (SAVR)
  • Experimental: Edwards SAPIEN 3 THV
    Intervention: Device: Transcatheter Aortic Valve Replacement (TAVR)
Publications *

*   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: December 19, 2016)
1328
Original Estimated Enrollment  ICMJE
 (submitted: February 2, 2016)
1228
Estimated Study Completion Date  ICMJE March 2027
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. No age restriction.
  2. Severe, calcific aortic stenosis.
  3. Heart team agrees the patient has a risk of operative mortality and has an STS <4.
  4. The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site.

Exclusion Criteria:

  1. Ilio-femoral vessel characteristics that would preclude safe placement of the introducer sheath.
  2. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization.
  3. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.
  4. Severe aortic regurgitation (>3+).
  5. Severe mitral regurgitation (>3+).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Justine Encabo, BS 949-250-3502 Justine_Encabo@edwards.com
Contact: John Tejeda, MPAS, D.H.A. 949-250-8497 John_Tejeda@edwards.com
Listed Location Countries  ICMJE Australia,   Canada,   Japan,   New Zealand,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02675114
Other Study ID Numbers  ICMJE 2015-08
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
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
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: Martin B Leon, MD, FACC Columbia University Medical Center/ New York Presbyterian Hospital, NY
Principal Investigator: Michael J Mack, MD, FACC The Heart Hospital Baylor Plano, TX
PRS Account Edwards Lifesciences
Verification Date July 2019

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