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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 : November 22, 2017
Information provided by (Responsible Party):
Edwards Lifesciences

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).

Condition or disease Intervention/treatment
Aortic Stenosis Procedure: Surgical aortic valve replacement (SAVR) Device: Transcatheter Aortic Valve Replacement (TAVR)

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1328 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : March 2027

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Surgical aortic valve replacement (SAVR) Procedure: Surgical aortic valve replacement (SAVR)
SAVR with a commercially available bioprosthetic valve.
Other Name: SAVR
Experimental: Edwards SAPIEN 3 THV Device: Transcatheter Aortic Valve Replacement (TAVR)
TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve and Edwards Commander Delivery System
Other Names:
  • TAVR
  • TAVI

Primary Outcome Measures :
  1. 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%

Secondary Outcome Measures :
  1. Length of index hospitalization (Device and Control group) [ Time Frame: Number of days from index procedure to discharge (expected average of 7 days) ]
  2. Death or Stroke [ Time Frame: 30 Days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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+).

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): NCT02675114

Contact: Leticia B Fields, BS 949-250-3453 Leticia_BarrazaFields@edwards.com
Contact: Vinny Podichetty, MD 949-250-5794 Vinny_Podichetty@edwards.com

  Show 76 Study Locations
Sponsors and Collaborators
Edwards Lifesciences
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

Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT02675114     History of Changes
Other Study ID Numbers: 2015-08
First Posted: February 5, 2016    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Sapien 3
cardiovascular disease
heart disease
aortic stenosis

Additional relevant MeSH terms:
Constriction, Pathologic
Aortic Valve Stenosis
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction