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

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.

Study Overview

• Status: Terminated
• Conditions: Aortic Valve Replacement
• Intervention / Treatment: Diagnostic test: Subjects previously implanted with a RESILIA aortic tissue valve.

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 Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California
  • Florida
    • Gainesville, Florida, United States, 32608
      • University of Florida - Shands Hospital
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland, Baltimore
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center-NY Presbyterian Hospital
    • New York, New York, United States, 10065
      • Weill Cornell - NYC
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
  • Pennsylvania
    • Mechanicsburg, Pennsylvania, United States, 17050
      • Pinnacle Health
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine - St. Luke's Hospital
    • Plano, Texas, United States, 75093
      • The Heart Hospital of Baylor Plano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects previously implanted with a RESILIA aortic tissue valve.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to bioprosthetic valve failure due to valve deterioration	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.	11 years post-implant

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Edwards Lifesciences
• Investigators: Principal Investigator: Joseph Bavaria, MD, Organizational Affiliation: Hospital of the University of Pennsylvania; Principal Investigator: Lars Svensson, MD, PhD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2018
• Primary Completion (Actual): February 13, 2024
• Study Completion (Actual): February 13, 2024

Study Registration Dates

• First Submitted: September 10, 2018
• First Submitted That Met QC Criteria: September 19, 2018
• First Posted (Actual): September 21, 2018

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2018-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes