Active — Not RecruitingNot Applicable

ExCEED: CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis

United States101 participantsStarted 2018-09-18

Plain-language summary

This study will monitor the safety and valve performance of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe, calcific aortic stenosis who are at intermediate operative risk for surgical aortic valve replacement (SAVR).

Who can participate

SexALL

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Inclusion criteria

✓. Severe, calcific AS
✓. NYHA 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 sizes 23, 26 or 29 mm CENTERA THV based on 3D imaging analysis
✕. Aortic valve is unicuspid, bicuspid or non-calcified
✕. Pre-existing mechanical or bioprosthetic valve in any position
✕. Known hypersensitivity to Nitinol (nickel or titanium)
✕. 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

What they're measuring

All-cause Death

Timeframe: 1 year

Trial details

NCT IDNCT03517436

SponsorEdwards Lifesciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-10-02

Results submitted2021-09-02

View on ClinicalTrials.gov More Aortic Valve Stenosis trials