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

Eligibility

Eligible Ages
Over 19 Years
Eligible Genders
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)/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+).

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Surgical aortic valve replacement (SAVR)
  • Procedure: Surgical aortic valve replacement (SAVR)
    SAVR with a commercially available bioprosthetic valve.
    Other names:
    • 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

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030

More Details

NCT ID
NCT02675114
Status
Recruiting
Sponsor
Edwards Lifesciences

Study Contact

Justine Encabo, BS
949-250-3502
Justine_Encabo@edwards.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.