Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorEnCompass Technologies, Inc.
About 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 does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patient requires an urgent or emergent TAVR procedure.
Any interventional cardiovascular procedure performed within 30 days prior to TAVR procedure or planned within 30 days post-TAVR procedure.
Diagnostic cardiac catheterization within 10 days prior to TAVR procedure.
Evidence of an acute myocardial infarction within 3 months prior to TAVR procedure.
Trial design
Design model
Parallel
Treatments tested in this trial
F2 Filter and Delivery System
DeviceUse of the F2 Filter and Delivery System in conjunction with a Transcatheter Aortic Valve Replacement (TAVR) procedure
Transcatheter Aortic Valve Replacement (TAVR)
Procedure/SurgeryTranscatheter Aortic Valve Replacement (TAVR) with commercially available Transcatheter Aortic Valve Replacement (TAVR) device
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: F2 Filter and Delivery SystemExperimental treatment 2 interventions
Group B: Either the Sentinel Cerebral Protection System or no embolic protection deviceActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Major Adverse Cardiac and Cerebrovascular Events (MACCE)
MACCE includes the composite of death, all stroke, acute kidney injury (AKI) stage 3 or 4 within 7 days post-index procedure Valve Academic Research Consortium 3 (VARC-3) and any major vascular complication (VARC-3)
Time frame
30 days post procedure2
Total New Lesion Volume
Total new lesion volume (TNLV) in the brain assessed by diffusion weighted magnetic resonance images (DW-MRI)
Time frame
8-72 hours post procedureSecondary outcomes
1
Stroke
Incidence of all stroke events
Time frame
30 days post procedureOther outcomes
1
Performance
Technical success (% of patients with successful device deployment, position and retrieval) and procedure success (% of patients with technical device success and no device-related safety events)
Time frame
During procedure2
Mortality & Stroke Rates
Incidences of all-cause mortality, major stroke, minor stroke events
Time frame
30 days post procedure3
Freedom from Lesions
Measure presence or absence of new lesions in the brain, assessed by diffusion weighted magnetic resonance images (DW-MRI)
Time frame
8-72 hours post procedure4
Average Lesion Size
Measure average lesion size in the brain, assessed by diffusion weighted magnetic resonance images (DW-MRI)
Time frame
8-72 hours post procedureSponsors and contacts
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Source ClinicalTrials.gov