Actively Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Led by EnCompass Technologies, Inc. · Updated on 2025-11-20
500
Participants Needed
10
Research Sites
68 weeks
Total Duration
On this page
Sponsors
E
EnCompass Technologies, Inc.
Lead Sponsor
A
Avania
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 50 years or older
- Scheduled to undergo Transfemoral Transcatheter Aortic Valve Replacement (TAVR) per physician's indication
- Willing and able to comply with protocol follow-up evaluations
- Able and willing to provide written informed consent
- Meets criteria for use of the control device (Sentinel device) per instructions for use
You will not qualify if you...
- Requires urgent or emergent TAVR procedure
- Any interventional cardiovascular procedure within 30 days before or planned within 30 days after TAVR
- Diagnostic cardiac catheterization within 10 days before TAVR
- Acute myocardial infarction within 3 months prior to TAVR
- Prior prosthetic heart valve in any position
- Known intracardiac thrombus
- Active infection or endocarditis
- Contraindications to anti-platelet or anticoagulant therapy
- Refusal of blood transfusion
- Renal insufficiency with creatinine > 2.5 mg/dL or GFR < 30, or on renal replacement therapy
- Hepatic failure (Child-Pugh class C)
- Severe ventricular dysfunction with LVEF < 30%
- Females who are pregnant, nursing, or planning pregnancy during study participation
- Modified Rankin Scale score ≥ 2 at screening
- Cerebrovascular event including TIA within 6 months before procedure
- Active major psychiatric disease or history of substance abuse affecting compliance
- Severe visual, auditory, or learning impairments
- Neurodegenerative or other progressive neurological diseases, significant head trauma with persistent deficits, or known brain abnormalities
- Contraindications to MRI including unsafe implants, metal fragments, or clips in brain or eye before TAVR
- High risk of complete AV block after TAVR requiring permanent pacemaker
- Claustrophobia preventing MRI scans
- Severe peripheral, abdominal, or thoracic aortic disease preventing device delivery or filter deployment
- Cardiovascular implants in aorta or peripheral access vessels
- Access vessels with excessive tortuosity
- Severely calcified, atheromatous, or tortuous aortic arch
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
NCH Baker Hospital-Naples Heart Institute
Naples, Florida, United States, 34102
Not Yet Recruiting
2
St. Vincent Hospital
Indianappolis, Indiana, United States, 46260
Actively Recruiting
3
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
4
St. Lukes Hospital Of Kansas City
Kansas City, Missouri, United States, 64111
Actively Recruiting
5
Cumc/Nyph
New York, New York, United States, 10032
Actively Recruiting
6
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
7
Ohio Health Research Institute (aka Riverside Methodist Hospital)
Columbus, Ohio, United States, 43214
Not Yet Recruiting
8
University of Virginia Medical Center
Charlottesville, Virginia, United States, 22903
Not Yet Recruiting
9
St Andrews War Memorial Hospital
Spring Hill, Queensland, Australia, 4000
Not Yet Recruiting
10
Monash Health Public
Clayton, Victoria, Australia, 3168
Actively Recruiting
Research Team
K
Kathleen S Calderon
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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