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Trial record 1 of 1 for:    NCT02675114
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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)

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: NCT02675114
Recruitment Status : Recruiting
First Posted : February 5, 2016
Last Update Posted : August 2, 2019
Sponsor:
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 Phase
Aortic Stenosis Procedure: Surgical aortic valve replacement (SAVR) Device: Transcatheter Aortic Valve Replacement (TAVR) Not Applicable

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.

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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 : January 2020
Estimated Study Completion Date : March 2027

Resource links provided by the National Library of Medicine


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 ]

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

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.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
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)/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+).

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
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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

Locations
Hide Hide 81 study locations
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United States, Alabama
University of Alabama Active, not 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 Active, not recruiting
Los Angeles, California, United States, 90095
Hoag Hospital Active, not recruiting
Newport Beach, California, United States, 92663
Stanford Hospital and Clinics Recruiting
Palo Alto, California, United States, 94305
Sutter Health Sacramento Active, not recruiting
Sacramento, California, United States, 95816
Kaiser Permanente San Francisco Active, not 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 Active, not recruiting
Atlantis, Florida, United States, 33462
University of Florida, Gainesville Active, not recruiting
Gainesville, Florida, United States, 32610
Mount Sinai Medical Center Active, not recruiting
Miami Beach, Florida, United States, 33140
Florida Hospital Active, not 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 Active, not recruiting
Honolulu, Hawaii, United States, 96813
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Rush University Medical Center Active, not recruiting
Chicago, Illinois, United States, 60612
NorthShore University HealthSystem Research Institute Recruiting
Evanston, Illinois, United States, 60201
Prairie Education and Research Cooperative Active, not recruiting
Springfield, Illinois, United States, 62701
United States, Iowa
University of Iowa Hospitals and Clinics Active, not recruiting
Iowa City, Iowa, United States, 52242
United States, Kansas
Cardiovascular Research Institute of Kansas Active, not recruiting
Wichita, Kansas, United States, 67226
United States, Louisiana
UPR - Louisiana State University Health Science Center Recruiting
New Orleans, Louisiana, United States, 70112
Ochsner Clinic Foundation Active, not recruiting
New Orleans, Louisiana, United States, 70121
United States, Maine
Central Maine Medical Center Active, not 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 Active, not recruiting
Royal Oak, Michigan, United States, 48073
United States, Minnesota
University of Minnesota Medical Center Recruiting
Minneapolis, Minnesota, United States, 55455
Mayo Clinic Active, not recruiting
Rochester, Minnesota, United States, 55905
United States, Missouri
Saint Luke's Hospital of Kansas City Mid America Active, not 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 Active, not recruiting
Lincoln, Nebraska, United States, 68526
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Active, not 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 Israel Recruiting
Newark, New Jersey, United States, 07112
United States, New York
Albany Active, not 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
UPR - Novant Health Heart and Vascular Institution Recruiting
Charlotte, North Carolina, United States, 28204
Rex Hospital / NC Heart and Vascular Research Active, not 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
UPR-Oklahoma Heart Institute Recruiting
Tulsa, Oklahoma, United States, 74104
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
UPR - Methodist LeBonheur Germantown Hospital Recruiting
Germantown, Tennessee, United States, 38138
Baptist Memorial Hospital Active, not 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 Active, not recruiting
Dallas, Texas, United States, 75230
UPR - Medical City Dallas Hospital Recruiting
Dallas, Texas, United States, 75230
Hospital of Providence - Sierra El Paso Recruiting
El Paso, Texas, United States, 79902
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
United States, Utah
Intermountain Medical Center Recruiting
Salt Lake City, Utah, United States, 84157
United States, Virginia
University of Virginia Active, not 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 Active, not recruiting
Madison, Wisconsin, United States, 53792
Australia, Queensland
The Prince Charles Hospital Withdrawn
Chermside, Queensland, Australia, 4032
Australia, South Australia
Royal Adelaide Hospital Active, not recruiting
Adelaide, South Australia, Australia, 5000
Flinders Medical Centre Active, not recruiting
Bedford Park, South Australia, Australia, 5042
Canada
Saint Paul's Hospital Active, not recruiting
Vancouver, Canada
Japan
Kokura Memorial Hospital Recruiting
Kitakyushu, Fukuoka, Japan, 802-8555
Sendai Kousei Hospital Recruiting
Sendai, Miyagi, Japan, 980-0873
Osaka University Active, not recruiting
Suita, Osaka, Japan, 565-0871
Teikyo University Active, not recruiting
Itabashi, Tokyo, Japan, 173-8606
Keio University Active, not recruiting
Shinjuku, Tokyo, Japan, 160-8582
New Zealand
Auckland City Hospital Active, not recruiting
Grafton, Auckland, New Zealand, 1024
Sponsors and Collaborators
Edwards Lifesciences
Investigators
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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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT02675114    
Other Study ID Numbers: 2015-08
First Posted: February 5, 2016    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Edwards Lifesciences:
Sapien 3
cardiovascular disease
heart disease
aortic stenosis
SAVR
TAVR
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction