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

Edwards Lifesciences

Status: Terminated

Conditions: Aortic Valve Replacement

Treatments: Diagnostic Test: Subjects previously implanted with a RESILIA aortic tissue valve.

Study type: Observational

Funder types: Industry

Identifiers

NCT03680040

2018-06

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 110 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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