Prospective Non-Randomized Single-Arm Multi-Center Evaluation of the Durability of Aortic Bioprostheses/Valves with RESILIA Tissue in Subjects Under 65 (RESILIENCE Trial)

Clinical Trial Details

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 in RESILIA tissue valves.

Key Eligibility:

Subjects under 65 years old (at time of implant) previously implanted with a RESILIA treated aortic bioprosthesis

*All bioprostheses have been previously implanted; this trial incorporates new evaluations and a longer evaluation period for this population of previously implanted subjects.

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Study contact by location

Upper East Side - Manhattan

Contact(s)

Nathan Palaparthi
212-746-5194
ntp2001@med.cornell.edu

Primary Investigator(s)

Leonard N Girardi, MD (UES)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1809019568

ClinicalTrials.gov:

NCT03680040

Status

Open to Enrollment

Age Group

Adult

Disease

Cardiovascular/Heart