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

Terminated

• Conditions: Aortic Valve Replacement

• Registration Number: NCT03680040
• Lead Sponsor: Edwards Lifesciences

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.

Study Timeline

• Study First Submitted: 2018-09-10
• Study First Submitted QC: 2018-09-19
• Study First Posted: 2018-09-21
• Study Start: 2018-11-05
• Primary Completion: 2024-02-13
• Study Completion: 2024-02-13
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to bioprosthetic valve failure due to valve deterioration	11 years post-implant	Time to bioprosthetic valve failure due to valve deterioration is defined as subject requiring valve re-intervention (redo surgery, valve-in-valve) or confirmed study valve-related death.

Secondary Outcome Measures

Name	Time	Method
Collection of early possible predictors of valve failure including leaflet calcification and morphological/hemodynamic valve deterioration	5, 7, 9, and 11 years post-implant	1. Quantification of valve leaflet calcification via core lab evaluated multi-slice computed tomography (MSCT); 2. Hemodynamic performance of the valve and evaluation for possible morphological/hemodynamic valve deterioration confirmed by core lab evaluation of echo-cardiography

Trial Locations

Locations (10)

University of Florida - Shands Hospital; 🇺🇸 Gainesville, Florida, United States

Weill Cornell - NYC; 🇺🇸 New York, New York, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Columbia University Medical Center-NY Presbyterian Hospital; 🇺🇸 New York, New York, United States

Baylor College of Medicine - St. Luke's Hospital; 🇺🇸 Houston, Texas, United States

Pinnacle Health; 🇺🇸 Mechanicsburg, Pennsylvania, United States

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

The Heart Hospital of Baylor Plano; 🇺🇸 Plano, Texas, United States

University of Southern California; 🇺🇸 Los Angeles, California, United States

University of Maryland, Baltimore; 🇺🇸 Baltimore, Maryland, United States