Clinical trial NCT03680040: RESILIENCE Trial: Evaluation of the Durability of Aortic Bioprostheses/Valves With RESILIA Tissue in Subjects Under 65
Official title: Prospective Non-randomized Single Arm Multi-center Evaluation of the Durability of Aortic Bioprostheses/Valves With RESILIA Tissue in Subjects Under 65 (RESILIENCE Trial)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Aortic Valve Replacement
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2018-09-21
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects previously implanted with a RESILIA aortic tissue valve.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to bioprosthetic valve failure due to valve deterioration
timeFrame: 11 years post-implant
Secondary outcomes:
measure: Collection of early possible predictors of valve failure including leaflet calcification and morphological/hemodynamic valve deterioration
timeFrame: 5, 7, 9, and 11 years post-implant
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Gainesville
country: United States
facility: University of Florida - Shands Hospital
state: Florida
city: Baltimore
country: United States
facility: University of Maryland, Baltimore
state: Maryland
city: New York
country: United States
facility: Columbia University Medical Center-NY Presbyterian Hospital
state: New York
city: New York
country: United States
facility: Weill Cornell - NYC
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Mechanicsburg
country: United States
facility: Pinnacle Health
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine - St. Luke's Hospital
state: Texas
city: Plano
country: United States
facility: The Heart Hospital of Baylor Plano
state: Texas
Study officials:
affiliation: Organizational Affiliation: Hospital of the University of Pennsylvania
name: Joseph Bavaria, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Lars Svensson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: