A Prospective, Single-Arm, Single Center Feasibility Trial to Evaluate the Safety and Performance of the F2 Filter and Delivery System Used for Embolic Protection During Transcatheter Aortic Valve Replacement
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY
The goal of this clinical trial is to learn about the safety and performance of the F2 device for cerebral embolic protection in participants with symptomatic aortic stenosis underdoing a Transcatheter Aortic Valve replacement procedure. Participants will complete several neurocognitive assessments and an MRI procedure.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Healthy Volunteers: f
View:
⁃ criteria:
• Age ≥ 22 years.
• The patient meets the established criteria and indications for commercially available TAVR (Edwards/Medtronic) for transfemoral access.
• Montreal Cognitive Assessment (MoCA) score ≥ 26 at screening.
• The patient is willing and able to comply with protocol-specified follow-up evaluations.
• The patient or legally authorized representative is able and willing to provide written informed consent.
Locations
Other Locations
Georgia
Healthycore
RECRUITING
Tbilisi
Contact Information
Primary
Kathleen Calderon
kcalderon@encompassf2.com
307-250-2726
Backup
Francis Duhay, MD
fduhay@encompassf2.com
949-285-8170
Time Frame
Start Date: 2023-04-29
Estimated Completion Date: 2026-01-30
Participants
Target number of participants: 10
Treatments
Experimental: Intervention
Placement of the F2 device in the aorta to cover the great cerebral vessels.
Related Therapeutic Areas
Sponsors
Leads: EnCompass Technologies, Inc.