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

Sponsor
Edwards Lifesciences (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT03680040
Collaborator
(none)
250
Enrollment
11
Locations
108.8
Anticipated Duration (Months)
22.7
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
250 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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)
Actual Study Start Date :
Nov 5, 2018
Anticipated Primary Completion Date :
Dec 1, 2027
Anticipated Study Completion Date :
Dec 1, 2027

Outcome Measures

Primary Outcome Measures

  1. 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

  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]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Southern California Los Angeles California United States 90033
2 University of Florida - Shands Hospital Gainesville Florida United States 32610
3 University of Maryland, Baltimore Baltimore Maryland United States 21201
4 Columbia University Medical Center-NY Presbyterian Hospital New York New York United States 10032
5 Weill Cornell - NYC New York New York United States 10065
6 Cleveland Clinic Foundation Cleveland Ohio United States 44195
7 Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104
8 Pinnacle Health Wormleysburg Pennsylvania United States 17043
9 Baylor College of Medicine - St. Luke's Hospital Houston Texas United States 77030
10 The Heart Hospital of Baylor Plano Plano Texas United States 75093
11 Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego Warsaw Poland 04-628

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT03680040
Other Study ID Numbers:
  • 2018-06
First Posted:
Sep 21, 2018
Last Update Posted:
Aug 2, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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

Study Results

No Results Posted as of Aug 2, 2022