Active — Not RecruitingNot Applicable

Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).

United States1,746 participantsStarted 2012-04

Plain-language summary

The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients to either Surgical Aortic Valve Replacement (SAVR) or TAVI with the Medtronic CoreValve® System. Single Arm: The purpose of this trial is to evaluate the safety and effectiveness of transcatheter aortic valve implementation (TAVI) in patients with severe symptomatic Aortic Stenosis (AS) at intermediate surgical risk with TAVI. This is a non-randomized phase of the pivotal clinical trial.

Who can participate

SexALL

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Inclusion criteria

✓. Critical aortic valve area defined as an initial aortic valve area of ≤1.0cm2 or aortic valve area index \< 0.6cm2/m2 AND
✓. Mean gradient \> 40mmHg or Vmax \> 4m/sec by resting echocardiogram or simultaneous pressure recordings at cardiac catherization \[or with dobutamine stress, if subject has left ventricular ejection fraction (LVEF) \<55%\] or velocity ratio \< 0.25;

Exclusion criteria

✕. Subject is \< 80 years of age and three or more of the following apply
✕. Subject is ≥ 80 years of age and two or more of the following apply

What they're measuring

All-cause Mortality or Disabling Stroke Rate Expressed as a Posterior Probability

Timeframe: 24 months

Trial details

NCT IDNCT01586910

SponsorMedtronic Cardiovascular

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-07

Results submitted2019-07-17

View on ClinicalTrials.gov More Severe Aortic Stenosis trials