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
EnCompass Technologies, Inc.
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)
Description
The study is designed to demonstrate that the F2 Cerebral Protection System (CPS) performs in a consistent manner as the control group in terms of safety, and the F2 Cerebral Protection System (CPS) will be superior in performance when compared to the control group in terms of effectiveness in patients undergoing Transcatheter Aortic Valve Replacement (TF TAVR).
Eligibility
- Age range
- 50+ years
- Sex
- All
- Healthy volunteers
- No
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 evaluations. * Patient is able and willing to provide written informed consent. * Patient meets all criteria for use of control device (Sentinel device, per IFU). Key Exclusion Criteria: General Exclusion Criteria: * Patient requires an urgent or emergent TAVR procedure. * Any interventional cardiovascu…
Interventions
- DeviceF2 Filter and Delivery System
Use of the F2 Filter and Delivery System in conjunction with a Transcatheter Aortic Valve Replacement (TAVR) procedure
- ProcedureTranscatheter Aortic Valve Replacement (TAVR)
Transcatheter Aortic Valve Replacement (TAVR) with commercially available Transcatheter Aortic Valve Replacement (TAVR) device
Locations (10)
- NCH Baker Hospital-Naples Heart InstituteNaples, Florida
- St. Vincent HospitalIndianappolis, Indiana
- Henry Ford HospitalDetroit, Michigan
- St. Lukes Hospital Of Kansas CityKansas City, Missouri
- Cumc/NyphNew York, New York
- Cleveland Clinic FoundationCleveland, Ohio