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



Status:Enrolling by invitation
Healthy:No
Age Range:18 - 64
Updated:3/28/2019
Start Date:November 5, 2018
End Date:December 2027

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

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.

Multicenter, prospective, non-randomized, single-arm, observational trial. Subjects will be
evaluated at 5, 7, 9, and 11 years post-implant. Up to two hundred fifty (250) total subjects
at up to fifteen (15) investigational sites will be enrolled.

Inclusion Criteria:

1. 18 years or older

2. Subject currently has an Edwards pericardial aortic bioprosthesis with RESILIA tissue

3. Provides voluntary written informed consent prior to the first trial related procedure

4. Subject agrees to attend follow-up assessments as specified in the protocol

Exclusion Criteria:

1. Age 65 years or older at time of aortic valve replacement

2. The Subject is pregnant or planning to become pregnant at the time of screening

3. Re-intervention required on the bioprosthetic aortic valve prior to screening

4. Active endocarditis or history of endocarditis on bioprosthetic aortic valve

5. Estimated life expectancy <24 months

6. Subjects with history of or current renal failure requiring dialysis

7. Altered mineral metabolism (hyperparathyroidism, parathyroid tumors)

8. Has prior organ transplant or is currently an organ transplant candidate
We found this trial at
7
sites
Los Angeles, California 90008
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Los Angeles, CA
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Philadelphia, PA
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Cleveland, OH
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Gainesville, Florida 32608
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Gainesville, FL
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New York, NY
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4700 Alliance Boulevard
Plano, Texas 75093
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Plano, TX
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Wormleysburg, Pennsylvania 17043
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Wormleysburg, PA
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