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NCT03680040 · ClinicalTrials.gov registry record
RESILIENCE Trial: Evaluation of the Durability of Aortic Bioprostheses/Valves With RESILIA Tissue in Subjects Under 65
A clinical trial, sponsored by Edwards Lifesciences.
- Terminated
- Registry status
- 110
- Enrollment target
NCT03680040: Clinical Trial study, sponsored by Edwards Lifesciences.
NCT03680040 is a clinical trial that was terminated before completion, run by Edwards Lifesciences. The registered enrollment target is 110 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03680040 was terminated before completion, sponsored by Edwards Lifesciences.
- TERMINATED
- Registry status
- 110 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DIAGNOSTIC_TEST Subjects previously implanted with a RESILIA aortic tissue valve.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2018-11-05 |
| Est. Completion | 2024-02-13 |
Why NCT03680040 stopped before completion
NCT03680040 is an observational study that tracks outcomes without assigning an intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Subjects previously implanted with a RESILIA aortic tissue valve. is the first listed.
NCT03680040 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03680040 about?
NCT03680040 is a clinical study titled "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 durability (e.g., calcification and hemodynamic deterioration) in RESILIA tissue valves.
What is the current status of trial NCT03680040?
This trial is currently terminated. The enrollment target is 110 participants. The study started on 2018-11-05. Estimated completion is 2024-02-13.
What interventions are being tested in trial NCT03680040?
The interventions under investigation include: Subjects previously implanted with a RESILIA aortic tissue valve. (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03680040?
This trial is sponsored by Edwards Lifesciences, which has 57 total clinical trials registered on ClinicalTrials.gov.
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