The REFLECT Trial: A Randomized Evaluation oF the TriGuard HDH Cerebral Embolic Protection Device and the TriGUARD 3 Cerebral Embolic Protection Device to Reduce the Impact of Cerebral Embolic LEsions after TransCatheter Aortic Valve ImplanTation
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- STATUS
- Recruiting
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- participants needed
- 40
Summary
This is a research study designed to look at the safety and effectiveness of the TriGUARD 3 cerebral embolic protection device in patients undergoing transcatheter aortic valve implantation (TAVI). The purpose of the study is to assess whether the TriGUARD 3 can prevent death, stroke, more subtle signs of brain injury, and/or silent brain injury as measured by a magnetic resonance imaging (MRI) study of the brain.
Details
| Condition | Cerebral Embolic Lesion |
|---|---|
| Age | 99years or below |
| Clinical Study Identifier | 02536196 |
| Last Modified on | 19 February 2024 |
Eligibility
How to participate?
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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