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

NCT03680040 | Terminated FDA Device

• 1 other identifier: 2018-06
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 10

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.

Conditions

Aortic Valve Replacement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Collection of early possible predictors of valve failure including leaflet calcification and morphological/hemodynamic valve deterioration

  5, 7, 9, and 11 years post-implant

Interventions

Subjects previously implanted with a RESILIA aortic tissue valve. DIAGNOSTIC_TEST

Subjects to undergo multi-slice computed tomography and echocardiogram to assess predictors of valve durability in previously implanted Edwards aortic valves with RESILIA tissue.

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects previously implanted with a RESILIA aortic tissue valve.

You may qualify if:

• years or older
• Subject currently has an Edwards pericardial aortic bioprosthesis with RESILIA tissue
• Provides voluntary written informed consent prior to the first trial related procedure
• Subject agrees to attend follow-up assessments as specified in the protocol

You may not qualify if:

• Age 65 years or older at time of aortic valve replacement
• The Subject is pregnant or planning to become pregnant at the time of screening
• Re-intervention required on the bioprosthetic aortic valve prior to screening
• Active endocarditis or history of endocarditis on bioprosthetic aortic valve
• Estimated life expectancy \<24 months
• Subjects with history of or current renal failure requiring dialysis
• Altered mineral metabolism (hyperparathyroidism, parathyroid tumors)
• Has prior organ transplant or is currently an organ transplant candidate

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (10)

University of Southern California

Los Angeles, California, 90033, United States

Location

University of Florida - Shands Hospital

Gainesville, Florida, 32608, United States

Location

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

Columbia University Medical Center-NY Presbyterian Hospital

New York, New York, 10032, United States

Location

Weill Cornell - NYC

New York, New York, 10065, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Pinnacle Health

Mechanicsburg, Pennsylvania, 17050, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Baylor College of Medicine - St. Luke's Hospital

Houston, Texas, 77030, United States

Location

The Heart Hospital of Baylor Plano

Plano, Texas, 75093, United States

Location

Study Officials

• Joseph Bavaria, MD

  Organizational Affiliation: Hospital of the University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Lars Svensson, MD, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 21, 2018
• Study Start: November 5, 2018
• Primary Completion: February 13, 2024
• Study Completion: February 13, 2024
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)