Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorEnCompass Technologies, Inc.
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)
Eligibility criteria
Qualifiers
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 evaluations.
Patient is able and willing to provide written informed consent.
Disqualifiers
Patient requires an urgent or emergent TAVR procedure.
Any interventional cardiovascular procedure performed within 30 days prior to TAVR procedure or planned within 30 days post-TAVR procedure.
Diagnostic cardiac catheterization within 10 days prior to TAVR procedure.
Evidence of an acute myocardial infarction within 3 months prior to TAVR procedure.
Trial design
Treatments tested in this trial
- F2 Filter and Delivery System
- Transcatheter Aortic Valve Replacement (TAVR)
Treatment groups
500 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov