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

Stopped early

Conditions studied: Aortic Valve Replacement

In brief

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.

Key facts

Study ID

NCT03680040

Run by

Edwards Lifesciences

People needed

110

Starts

2018-11-05

Expected to finish

2024-02-13

Last updated by the study team

2024-05-09

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years or older
• Subject currently has an Edwards pericardial aortic bioprosthesis with RESILIA tissue
• Provides voluntary written informed consent prior to the first trial related procedure
• Subject agrees to attend follow-up assessments as specified in the protocol

You may not qualify if…

• Age 65 years or older at time of aortic valve replacement
• The Subject is pregnant or planning to become pregnant at the time of screening
• Re-intervention required on the bioprosthetic aortic valve prior to screening
• Active endocarditis or history of endocarditis on bioprosthetic aortic valve
• Estimated life expectancy <24 months
• Subjects with history of or current renal failure requiring dialysis
• Altered mineral metabolism (hyperparathyroidism, parathyroid tumors)
• Has prior organ transplant or is currently an organ transplant candidate

Where it is running

• University of Southern California — Los Angeles, California, United States
• University of Florida - Shands Hospital — Gainesville, Florida, United States
• University of Maryland, Baltimore — Baltimore, Maryland, United States
• Columbia University Medical Center-NY Presbyterian Hospital — New York, New York, United States
• Weill Cornell - NYC — New York, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Pinnacle Health — Mechanicsburg, Pennsylvania, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Baylor College of Medicine - St. Luke's Hospital — Houston, Texas, United States
• The Heart Hospital of Baylor Plano — Plano, Texas, United States

Full record on ClinicalTrials.gov

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