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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03680040
Other study ID # 2018-06
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date November 5, 2018
Est. completion date February 13, 2024

Study information

Verified date May 2024
Source Edwards Lifesciences
Contact n/a
Is FDA regulated No
Health authority
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 Terminated
Enrollment 110
Est. completion date February 13, 2024
Est. primary completion date February 13, 2024
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

Study Design


Related Conditions & MeSH terms


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
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