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

Aortic Valve Replacement Clinical Trial

— RESILIENCE  

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)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03680040
• Other study ID #: 2018-06
• Status: Enrolling by invitation
• Start date: November 5, 2018
• Est. completion date: December 2027

Study information

• Verified date: November 2023
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 250
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Replacement

Intervention

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

Locations

Country	Name	City	State
United States	University of Maryland, Baltimore	Baltimore	Maryland
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	University of Florida - Shands Hospital	Gainesville	Florida
United States	Baylor College of Medicine - St. Luke's Hospital	Houston	Texas
United States	University of Southern California	Los Angeles	California
United States	Pinnacle Health	Mechanicsburg	Pennsylvania
United States	Columbia University Medical Center-NY Presbyterian Hospital	New York	New York
United States	Weill Cornell - NYC	New York	New York
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	The Heart Hospital of Baylor Plano	Plano	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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