About Pricing FAQs Blog

Loading clinical trials...

Your health journey, clearly organized.

Find Clinical Trials →

Legal

Privacy Policy
Terms of Service

© 2026 Clareo Health. All rights reserved.

Back to clinical trial search

TERMINATEDNCT03680040

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

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 durabil...

Lead sponsor: Edwards Lifesciences•10 U.S. locations•View source on ClinicalTrials.gov

Clareo plain-language summary

What this study is about

Generating AI summary...

Save this trial guide to your notes

Keep your clinical trial research organized — questions to ask, what to expect, and key details.

Sponsors

Lead Sponsor

Edwards Lifesciences

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.

Age

18 - 64 years

Sex

ALL

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

Related studies

Frequency of Electrical Acupoint Stimulation on Hypotension in TAVR Patients

NCT07365345 · Transcatheter Aortic Valve Replacement (TAVR), Hemodynamic Stability, and more

Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease

NCT07267117 · Heart Valve Disease, Mitral Valve (MV) Regurgitation, and more

RECRUITINGPhase 4

CT TAVR Abdomen Study

NCT05758701 · Transcatheter Aortic Valve Replacement

RECRUITINGPhase 3

Short Versus Long Antiplatelet Therapy After TAVI

NCT06518317 · Transcatheter Aortic Valve Replacement

Prospective Validation of a Pre-Specified Algorithm for the Management of Conduction Disturbances Following TAVR

NCT04139616 · Conduction Disturbances, Transcatheter Aortic Valve Replacement, and more

View all related studies →

Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: May 9, 2024Terms

Trial snapshot

StatusTERMINATED

Phase—

Enrollment110

Start dateNov 2018

Last updatedMay 9, 2024

Condition

Aortic Valve Replacement

Locations shown

University of Southern California

Los Angeles, California

University of Florida - Shands Hospital

Gainesville, Florida

University of Maryland, Baltimore

Baltimore, Maryland

For caregivers

Use Clareo to keep notes, questions, trial details, and next steps organized before and after appointments.

Start free trial →

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 9, 2024Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions