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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.
See Contacts and Locations
Verified September 2017 by Edwards Lifesciences
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT02675114
First received: January 22, 2016
Last updated: September 13, 2017
Last verified: September 2017
  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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

  Show 76 Study Locations
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
Study First Received: January 22, 2016
Last Updated: September 13, 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

ClinicalTrials.gov processed this record on September 21, 2017