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Alternative Access Approaches for Transcatheter Aortic Valve Replace (TAVR) in Inoperable Patients With Aortic Stenosis

NCT01787084 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 8

Last updated 2025-04-06

No results posted yet for this study

Summary

Investigational study of Edwards Lifesciences, LLC's "Edwards SAPIEN Transcatheter Heart Valve" for non-femoral delivery, (or alternative access deliver) in patients with severe symptomatic native aortic valve stenosis who have been determined by a cardiac surgeon to be inoperable for open aortic valve replacement and in whom existing co-morbidities would not preclude the expected benefit from correction of the aortic stenosis. Will outcomes observed in a high-risk operable transapical native valve TAVR cohort receiving an Edwards SAPIEN device compare to inoperable patients undergoing alternative access TAVR with the Edwards SAPIEN device experience a reasonably similar incidence of 30 day adverse events?

Conditions

  • Severe Symptomatic Aortic Stenosis

Interventions

DEVICE

Edwards SAPIEN Transcatheter Heart Valve

Non-femoral transcatheter delivery of heart valve

Sponsors & Collaborators

Principal Investigators

  • John D Carroll, MD · American College of Cardiology

  • Fred H Edwards, MD · Society of Thoracic Surgeons

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2025-03-31
Completion
2025-03-31

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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 NCT01787084 on ClinicalTrials.gov