A Prospective, Randomized, Multicenter, Single-blind Trial to Assess the Safety and Effectiveness of the Encompass F2 Cerebral Protection System Vs. Standard of Care (Unprotected or Sentinel® Cerebral Protection System) During Transfemoral Transcatheter Aortic Valve Replacement
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:
• 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.
• Patient meets all criteria for use of control device (Sentinel device, per IFU).
Locations
United States
Florida
NCH Baker Hospital-Naples Heart Institute
NOT_YET_RECRUITING
Naples
Indiana
St. Vincent Hospital
RECRUITING
Indianappolis
Michigan
Henry Ford Hospital
RECRUITING
Detroit
Missouri
St. Lukes Hospital Of Kansas City
RECRUITING
Kansas City
New York
Cumc/Nyph
RECRUITING
New York
Ohio
Cleveland Clinic Foundation
RECRUITING
Cleveland
Ohio Health Research Institute (aka Riverside Methodist Hospital)
NOT_YET_RECRUITING
Columbus
Virginia
University of Virginia Medical Center
NOT_YET_RECRUITING
Charlottesville
Other Locations
Australia
Monash Health Public
RECRUITING
Clayton
St Andrews War Memorial Hospital
NOT_YET_RECRUITING
Spring Hill
Contact Information
Primary
Kathleen S Calderon
kcalderon@encompassf2.com
3072502726
Time Frame
Start Date: 2025-09-09
Estimated Completion Date: 2027-01
Participants
Target number of participants: 500
Treatments
Experimental: F2 Filter and Delivery System
The F2 Cerebral Embolic Protection System will be used during your Transcatheter Aortic Valve Replacement procedure
Active_comparator: Either the Sentinel Cerebral Protection System or no embolic protection device
Either the Sentinel Cerebral Protection System or no embolic protection device will be used during your Transcatheter Aortic Valve Replacement procedure depending on the Standard of Care at the treating institution
Related Therapeutic Areas
Sponsors
Leads: EnCompass Technologies, Inc.
Collaborators: Insight Medical Consulting, Avania