Feasibility Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
ConditionAortic Stenosis
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age22+
SponsorEnCompass Technologies, Inc.
About this trial
The goal of this clinical trial is to learn about the safety and performance of the F2 device for cerebral embolic protection in participants with symptomatic aortic stenosis underdoing a Transcatheter Aortic Valve replacement procedure.
Participants will complete several neurocognitive assessments and an MRI procedure.
Eligibility criteria
Qualifiers
Age ≥ 22 years.
The patient meets the established criteria and indications for commercially available TAVR (Edwards/Medtronic) for transfemoral access.
Montreal Cognitive Assessment (MoCA) score ≥ 26 at screening.
The patient is willing and able to comply with protocol-specified follow-up evaluations.
Disqualifiers
Contraindications to MRI (e.g., subjects with MR unsafe implants including implantable temporary or permanent pacemaker or defibrillator, metal implants in field of view, metallic fragments, clips, or devices in the brain or eye before TAVR procedure, or claustrophobia).
Severe peripheral arterial, abdominal aortic, or thoracic aortic disease that precludes delivery sheath vascular access or filter deployment.
Patients in whom the aortic arch is heavily calcified, severely atheromatous, or severely tortuous.
Ascending aortic diameter > 38 mm or transverse aortic diameter > 27 mm.
Trial design
Treatments tested in this trial
- F2 filter and delivery system
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov