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RESILIENCE Trial: Evaluation of the Durability of Aortic Bioprostheses/Valves With RESILIA Tissue in Subjects Under 65

NCT03680040 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 110

Last updated 2024-05-09

No results posted yet for this study

Summary

The objective of this observational trial is to determine time to valve failure due to valve deterioration requiring re-intervention and collect/investigate early potential predictors of valve durability (e.g., calcification and hemodynamic deterioration) in RESILIA tissue valves.

Conditions

  • Aortic Valve Replacement

Interventions

DIAGNOSTIC_TEST

Subjects previously implanted with a RESILIA aortic tissue valve.

Subjects to undergo multi-slice computed tomography and echocardiogram to assess predictors of valve durability in previously implanted Edwards aortic valves with RESILIA tissue.

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • Joseph Bavaria, MD · Organizational Affiliation: Hospital of the University of Pennsylvania

  • Lars Svensson, MD, PhD · The Cleveland Clinic

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-05
Primary Completion
2024-02-13
Completion
2024-02-13
FDA Device
Yes

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 NCT03680040 on ClinicalTrials.gov