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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
  Purpose
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 Intervention
Aortic Stenosis Procedure: Surgical aortic valve replacement (SAVR) Device: Transcatheter Aortic Valve Replacement (TAVR)

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Edwards Lifesciences:

Primary Outcome Measures:
  • 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:
  • 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 ]

Estimated Enrollment: 1328
Actual Study Start Date: March 2016
Estimated Study Completion Date: March 2027
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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+).
  Contacts and Locations
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


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

  Hide Study Locations
Locations
United States, Alabama
University of Alabama Recruiting
Birmingham, Alabama, United States, 35294
United States, Arizona
Banner University Medical Center Recruiting
Phoenix, Arizona, United States, 85006
United States, California
Mills/Peninsula Health Services Recruiting
Burlingame, California, United States, 94010
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
University of California, Los Angeles/Ronald Reagan Medical Center Recruiting
Los Angeles, California, United States, 90095
Hoag Hospital Recruiting
Newport Beach, California, United States, 92663
Mills-Peninsula Second Camps Recruiting
Oakland, California, United States, 94010
Stanford Hospital and Clinics Recruiting
Palo Alto, California, United States, 94305
Sutter Health Sacramento Recruiting
Sacramento, California, United States, 95816
Kaiser Permanente San Francisco Recruiting
San Francisco, California, United States, 94115
United States, Colorado
UC Health Northern Colorado/Medical Center of the Rockies Recruiting
Loveland, Colorado, United States, 80538
United States, Connecticut
Hartford Recruiting
Hartford, Connecticut, United States, 06102
United States, Florida
JFK Medical Center / Atlantic Clinical Research Collaborative Recruiting
Atlantis, Florida, United States, 33462
University of Florida, Gainesville Recruiting
Gainesville, Florida, United States, 32610
Mount Sinai Medical Center Recruiting
Miami Beach, Florida, United States, 33140
Florida Hospital Recruiting
Orlando, Florida, United States, 32803
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
United States, Hawaii
The Queen's Medical Center Recruiting
Honolulu, Hawaii, United States, 96813
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
NorthShore University HealthSystem Research Institute Recruiting
Evanston, Illinois, United States, 60201
Prairie Education and Research Cooperative Recruiting
Springfield, Illinois, United States, 62701
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
United States, Kansas
Cardiovascular Research Institute of Kansas Recruiting
Wichita, Kansas, United States, 67226
United States, Louisiana
Ochsner Clinic Foundation Recruiting
New Orleans, Louisiana, United States, 70121
United States, Maine
Central Maine Medical Center Recruiting
Auburn, Maine, United States, 04210
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
William Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48073
United States, Minnesota
University of Minnesota Medical Center Recruiting
Minneapolis, Minnesota, United States, 55455
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
United States, Missouri
Saint Luke's Hospital of Kansas City Mid America Recruiting
Kansas City, Missouri, United States, 64111
Barnes-Jewish Hospital / Washington University Recruiting
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Nebraska Heart Institute Recruiting
Lincoln, Nebraska, United States, 68526
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Morristown Medical Center / Atlantic Health System Hospital Recruiting
Morristown, New Jersey, United States, 07962
Newark Beth Second Campus (Rutgers Robert Wood Johnson Medical School) Recruiting
New Brunswick, New Jersey, United States, 08903
Newark Beth Israel Recruiting
Newark, New Jersey, United States, 07112
United States, New York
Albany Recruiting
Albany, New York, United States, 12208
University of Buffalo Recruiting
Buffalo, New York, United States, 14203
Winthrop-University Hospital Recruiting
Mineola, New York, United States, 11501
NYU Medical Center Recruiting
New York, New York, United States, 10016
Cornell University Recruiting
New York, New York, United States, 10021
Columbia University Medical Center/ New York Presbyterian Hospital Recruiting
New York, New York, United States, 10032
United States, North Carolina
Carolina's Health System Recruiting
Charlotte, North Carolina, United States, 28203
Rex Hospital / NC Heart and Vascular Research Recruiting
Raleigh, North Carolina, United States, 27607
United States, Ohio
The Christ Hospital, Cincinnati Recruiting
Cincinnati, Ohio, United States, 45219
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Mount Carmel Health System Recruiting
Columbus, Ohio, United States, 43213
United States, Oklahoma
Oklahoma Cardiovascular Research Group Recruiting
Oklahoma City, Oklahoma, United States, 73120
United States, Oregon
Providence Heart & Vascular Institute Recruiting
Portland, Oregon, United States, 97225
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Lankenau Medical Center Recruiting
Wynnewood, Pennsylvania, United States, 19096
York Hospital Recruiting
York, Pennsylvania, United States, 17403
United States, Tennessee
Baptist Memorial Hospital Recruiting
Memphis, Tennessee, United States, 38120
Saint Thomas Health Services Recruiting
Nashville, Tennessee, United States, 37205
United States, Texas
Austin Heart Recruiting
Austin, Texas, United States, 78756
Medical City Dallas Hospital Recruiting
Dallas, Texas, United States, 75230
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
The Heart Hosptial Baylor Plano Recruiting
Plano, Texas, United States, 75093
The Heart Hospital Baylor Plano Second Campus Recruiting
Temple, Texas, United States, 76508
United States, Utah
Intermountain Medical Center Recruiting
Salt Lake City, Utah, United States, 84157
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22904
Fairfax INOVA Recruiting
Falls Church, Virginia, United States, 22042
Sentara Cardiovascular Research Institute Recruiting
Norfolk, Virginia, United States, 23507
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53792
Australia, Queensland
The Prince Charles Hospital Recruiting
Chermside, Queensland, Australia, 4032
Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia, 5000
Flinders Medical Centre Recruiting
Bedford Park, South Australia, Australia, 5042
Canada
Saint Paul's Hospital Recruiting
Vancouver, Canada
Japan
Osaka University Recruiting
Suita, Osaka, Japan, 565-0871
Teikyo University Recruiting
Itabashi, Tokyo, Japan, 173-8606
Keio University Recruiting
Shinjuku, Tokyo, Japan, 160-8582
New Zealand
Auckland City Hospital Recruiting
Grafton, Auckland, New Zealand, 1024
Sponsors and Collaborators
Edwards Lifesciences
Investigators
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
  More Information

Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT02675114     History of Changes
Other Study ID Numbers: 2015-08
First Submitted: January 22, 2016
First Posted: February 5, 2016
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
SAVR
TAVR

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