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NCT04091048 · ClinicalTrials.gov registry record
Optimize PRO Study
A clinical trial, sponsored by Medtronic Cardiovascular.
- Completed
- Registry status
- 1,127
- Enrollment target
NCT04091048: Completed study, sponsored by Medtronic Cardiovascular.
NCT04091048 is a clinical trial that has completed, run by Medtronic Cardiovascular. The registered enrollment target is 1,127 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04091048 has completed, sponsored by Medtronic Cardiovascular.
- COMPLETED
- Registry status
- 1,127 participants
- Enrollment target
Study Summary
The purpose of this study is to collect clinical evidence on valve performance and procedural outcomes associated with an "optimized" TAVR care pathway and post-TAVR conduction disturbance pathway while using the Evolut™ PRO and Evolut™ PRO+ devices. The purpose of the addendum is to collect post-market clinical evidence on valve performance and procedural outcomes associated with the Evolut FX Device.
Primary Outcome
All-cause mortality or all-stroke at 30 days.
Interventions
- DEVICE Evolut™ PRO and Evolut™ PRO+ System (Evolut™ FX System for the addendum)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,127 participants |
| Start Date | 2019-09-16 |
| Est. Completion | 2024-11-13 |
What the finished NCT04091048 record still lists
NCT04091048 is an observational study that tracks outcomes without assigning an intervention. Its 1,127 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 1 intervention - of which Evolut™ PRO and Evolut™ PRO+ System (Evolut™ FX System for the addendum) is the first listed.
NCT04091048 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04091048 about?
NCT04091048 is a clinical study titled "Optimize PRO Study". The purpose of this study is to collect clinical evidence on valve performance and procedural outcomes associated with an "optimized" TAVR care pathway and post-TAVR conduction disturbance pathway while using the Evolut™ PRO and Evolut™ PRO+ devices. The purpose of the addendum is to collect post-m...
What is the current status of trial NCT04091048?
This trial is currently completed. The enrollment target is 1,127 participants. The study started on 2019-09-16. Estimated completion is 2024-11-13.
What interventions are being tested in trial NCT04091048?
The interventions under investigation include: Evolut™ PRO and Evolut™ PRO+ System (Evolut™ FX System for the addendum) (DEVICE).
Who is sponsoring clinical trial NCT04091048?
This trial is sponsored by Medtronic Cardiovascular, which has 44 total clinical trials registered on ClinicalTrials.gov.
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