CompletedNot Applicable

The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic, Severe Aortic Stenosis

Canada, United Kingdom100 participantsStarted 2018-06-01

Plain-language summary

This study will confirm the procedural safety and performance of the SAPIEN 3 Ultra System in subjects with severe, calcific AS who are at intermediate operative risk for standard aortic valve replacement.

Who can participate

SexALL

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Inclusion criteria

✓. Severe, calcific aortic stenosis meeting the following transthoracic echocardiogram criteria:
✓. New York Heart Association functional class ≥ II
✓. Judged by the Heart Team to be at intermediate risk for open surgical therapy
✓. The subject 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 available THV sizes on 3D imaging analysis
✕. Aortic valve is unicuspid, bicuspid or non-calcified
✕. Pre-existing mechanical or bioprosthetic valve in any position.
✕. Severe aortic regurgitation (\> 3+)
✕. Severe mitral regurgitation (\> 3+) or ≥ moderate stenosis
✕. Ventricular dysfunction with left ventricular ejection fraction \< 30%
✕. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
✕. Evidence of an acute myocardial infarction ≤ 30 days before the valve implant procedure

What they're measuring

Procedural Success

Timeframe: Day 0

Trial details

NCT IDNCT03471065

SponsorEdwards Lifesciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-12-23

Results submitted2020-12-22

View on ClinicalTrials.gov More Aortic Valve Stenosis trials