Active — Not RecruitingNot Applicable

PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis

United States1,000 participantsStarted 2016-03

Plain-language summary

To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement.

Who can participate

SexALL

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Inclusion criteria

✓. Severe, calcific aortic stenosis
✓. New York Heart Association Functional Class ≥ 2 OR exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR asymptomatic with Left Ventricular Ejection Fraction (LVEF) \<50%
✓. Heart team agrees the patient has a risk of operative mortality and has an Society of Thoracic Surgeons (STS) score \< 4
✓. The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion criteria

✕. Native aortic annulus size unsuitable for sizes 20, 23, 26, or 29 mm transcatheter heart valve
✕. Iliofemoral vessel characteristics that would preclude safe passage of the introducer sheath
✕. Evidence of an acute myocardial infarction ≤ 30 days before randomization
✕. Aortic valve is unicuspid, bicuspid, or non-calcified
✕. Severe aortic regurgitation (\>3+)
✕. Severe mitral regurgitation (\>3+) ≥ moderate stenosis
✕. Pre-existing mechanical or bioprosthetic valve in any position
✕. Complex coronary artery disease:

What they're measuring

All-cause Mortality, All Stroke, and Rehospitalization (Valve-related or Procedure-related and Including Heart Failure)

Timeframe: 1 year

Trial details

NCT IDNCT02675114

SponsorEdwards Lifesciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-11-16

Results submitted2021-10-07

View on ClinicalTrials.gov More Aortic Stenosis trials