CompletedNot Applicable

Safety & Efficacy Study of the Medtronic CoreValve® System-Treatment of Symptomatic Severe Aortic Stenosis With Significant Comorbidities in Extreme Risk Subjects Who Need Aortic Valve Replacement

United States782 participantsStarted 2012-08

Plain-language summary

To evaluate the safety and efficacy of the Medtronic CoreValve® System for the treatment of symptomatic severe aortic stenosis in subjects with significant comorbidities in whom the risk of surgical aortic valve replacement has a predicted operative mortality or serious, irreversible morbidity risk of ≥50% at 30 days.

Who can participate

SexALL

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Inclusion criteria

✓. Severe (≥3-4+) mitral valve regurgitation as measured by echocardiography
✓. Severe (≥3-4+) tricuspid valve regurgitation as measured by echocardiography
✓. End-stage renal disease requiring renal replacement therapy (Stage 5 of the KDOQI CKD Classification) or creatinine clearance \<20cc/min but not requiring renal replacement therapy

Exclusion criteria

✕. that could affect the implantation or function of the study valve OR
✕. the implantation of the study valve could affect the function of the pre-existing prosthetic heart valve

What they're measuring

All-cause Mortality or Major stroke

Timeframe: 12 months

Trial details

NCT IDNCT01675440

SponsorMedtronic Cardiovascular

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2016-12

View on ClinicalTrials.gov More Severe Aortic Stenosis trials