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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)

This study is currently recruiting participants.
Verified November 2017 by Edwards Lifesciences
Sponsor:
ClinicalTrials.gov Identifier:
NCT02675114
First Posted: February 5, 2016
Last Update Posted: November 22, 2017
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.
Information provided by (Responsible Party):
Edwards Lifesciences
January 22, 2016
February 5, 2016
November 22, 2017
March 2016
October 2018   (Final data collection date for primary outcome measure)
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%
Same as current
Complete list of historical versions of study NCT02675114 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
The PARTNER 3 - Trial - The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis
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
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).
Prospective, randomized, controlled, multi-center trial. Patients having an operative mortality < 2% (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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Aortic Stenosis
  • 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
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1328
March 2027
October 2018   (Final data collection date for primary outcome measure)

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) 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+).
Sexes Eligible for Study: All
19 Years and older   (Adult, Senior)
No
Contact: Leticia B Fields, BS 949-250-3453 Leticia_BarrazaFields@edwards.com
Contact: Vinny Podichetty, MD 949-250-5794 Vinny_Podichetty@edwards.com
Australia,   Canada,   Japan,   New Zealand,   United States
 
 
NCT02675114
2015-08
Yes
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
Plan to Share IPD: No
Edwards Lifesciences
Edwards Lifesciences
Not Provided
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
Edwards Lifesciences
November 2017

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