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.
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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

Kathleen S Calderon

3072502726

kcalderon@encompassf2.com

CONTACT