F2 Filter for Aortic Stenosis
(SHIELD Trial)
Recruiting at 5 trial locations
KS
Overseen ByKathleen S Calderon
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: EnCompass Technologies, Inc.
No Placebo Group
Trial Summary
What is the purpose of this trial?
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 Criteria
This trial is for patients with aortic stenosis, a condition where the heart's aortic valve narrows. Participants should be scheduled for Transcatheter Aortic Valve Replacement (TAVR), a procedure to replace the narrowed valve. Specific eligibility criteria are not provided but typically include age, health status, and absence of conditions that could complicate surgery.Inclusion Criteria
Patient meets all criteria for use of control device (Sentinel device, per IFU)
Patient is willing and able to comply with protocol-specified follow-up evaluations
I am approved for and scheduled to undergo a heart valve replacement through my leg.
See 2 more
Exclusion Criteria
Access vessels with excessive tortuosity
Known intracardiac thrombus
Patient has active major psychiatric disease, known mental or physical illness or known history of substance abuse that may cause non-compliance with the protocol or confound the data interpretation
See 22 more
Treatment Details
Interventions
- F2 Filter and Delivery System (Device)
Trial OverviewThe study tests the F2 Cerebral Protection System (CPS) against standard care during TAVR. The F2 CPS aims to protect the brain from embolic material—debris that might break loose during valve replacement and cause complications like stroke.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: F2 Filter and Delivery SystemExperimental Treatment2 Interventions
The F2 Cerebral Embolic Protection System will be used during your Transcatheter Aortic Valve Replacement procedure
Group II: Either the Sentinel Cerebral Protection System or no embolic protection deviceActive Control1 Intervention
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
EnCompass Technologies, Inc.
Lead Sponsor
Trials
4
Recruited
530+
Avania
Industry Sponsor
Trials
59
Recruited
10,000+
Insight Medical
Collaborator
Trials
1
Recruited
500+
Insight Medical Consulting
Collaborator
Trials
1
Recruited
500+