Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Recruiting
N/A
Interventional Study
Aortic Stenosis Treated With TAVI
Aortic Diseases
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 50 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 500 (estimated)
- Sponsor
- EnCompass Technologies, Inc. · Industry
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About This Trial
The objective of this study is to compare the safety and effectiveness of the F2 Cerebral Protection System (CPS) to a standard of care control group in patients undergoing Transcatheter Aortic Valve Replacement (TF TAVR)
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria:
* Age ≥ 50 years.
* Patient meets the established criteria and indications for commercially available TAVR via transfemoral access and is scheduled to undergo TAVR per their treating physician.
* Patient is willing and able to comply with protocol-specified follow-up evaluat…
Contacts