Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR

Part of paid clinical trials in Naples, Florida.

Sponsor
EnCompass Technologies, Inc.
Study ID
NCT06689839
Status
Recruiting
Apply to this trial

Conditions

  • Aortic Diseases
  • Aortic Stenosis Treated With TAVI

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • F2 Filter and Delivery System — DEVICE
    Use of the F2 Filter and Delivery System in conjunction with a Transcatheter Aortic Valve Replacement (TAVR) procedure
  • Transcatheter Aortic Valve Replacement (TAVR) — PROCEDURE
    Transcatheter Aortic Valve Replacement (TAVR) with commercially available Transcatheter Aortic Valve Replacement (TAVR) device

Study Details

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)

Key Dates

Start date
Sep 9, 2025
Status verified
Nov 2025
Primary completion
Dec 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Major Adverse Cardiac and Cerebrovascular Events (MACCE) [ Time Frame: 30 days post procedure ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
NCH Baker Hospital-Naples Heart InstituteNaplesFlorida34102
Kathy Byrd
(239)624-8113
Robert Cubeddu (PRINCIPAL_INVESTIGATOR)
St. Vincent HospitalIndianappolisIndiana46260
Kelly Verel
[email protected]
317-338-8042
James Hermiller, MD (PRINCIPAL_INVESTIGATOR)
Henry Ford HospitalDetroitMichigan48202
Stephen Krafchak
[email protected]
313-972-4018
Sara Poggio, RN
[email protected]
313-916-0119
Brian O'Neill, MD (PRINCIPAL_INVESTIGATOR)
St. Lukes Hospital Of Kansas CityKansas CityMissouri64111
Caroline Kempter
[email protected]
Anne Hoffman
[email protected]
816-932-5707
Cumc/NyphNew YorkNew York10032
Kate Dalton
[email protected]
212-342-1820
Treena Williams
[email protected]
Torsten Vahl, MD (PRINCIPAL_INVESTIGATOR)
Cleveland Clinic FoundationClevelandOhio44195
Emily Tylicki
[email protected]
216-287-8237
Amar Krishnaswamy, MD (PRINCIPAL_INVESTIGATOR)
Ohio Health Research Institute (aka Riverside Methodist Hospital)ColumbusOhio43214
Maureen McCormack
[email protected]
(614) 788-3885
Christina Belcher
[email protected]
614-813-4555
Steven Yakubov, MD (PRINCIPAL_INVESTIGATOR)
University of Virginia Medical CenterCharlottesvilleVirginia22903
Linda Bailes Bryceland
[email protected]
434-982-1058
John Saxon (PRINCIPAL_INVESTIGATOR)

Find similar trials in Naples, FL

By research site
NCH Baker Hospital-Naples Heart Institute· Naples, FLSt. Vincent Hospital· Indianappolis, INHenry Ford Hospital· Detroit, MISt. Lukes Hospital Of Kansas City· Kansas City, MOCumc/Nyph· New York, NYCleveland Clinic Foundation· Cleveland, OH

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