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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

NCT01675440 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 782

Last updated 2026-05-05

No results posted yet for this study

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.

Conditions

  • Severe Aortic Stenosis

Interventions

DEVICE

Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)

Sponsors & Collaborators

  • Medtronic Cardiovascular

    lead INDUSTRY

Principal Investigators

  • David H Adams · Mount Sinai Health System

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2016-12-31
Completion
2025-04-08

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01675440 on ClinicalTrials.gov