Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • F2 filter and delivery system

    Device

    Placement of F2 device in aorta to cover great cerebral vessels

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Major adverse cardiac and cerebrovascular events

Major adverse cardiac and cerebrovascular events

Time frame
30 days

Secondary outcomes

1

New lesions

total new lesion volume, average individual new lesion volume, number of new lesions, location of new lesions, territory of new lesions

Time frame
8-72 hours
2

Performance

technical success (% of patients with successful device deployment, position and retreival and procedure success (% of patients with technical device success and no device-related safety events)

Time frame
intra-procedure
3

Modified Rankin Scale

Measures neurological disability on scale of 0-6 (low score is better outcome)

Time frame
30 day
4

National Institute of Health Stroke Scale

Measures stroke severity on scale of 0 - 42 (low score is better outcome)

Time frame
30 day

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

EnCompass Technologies, Inc.

Lead sponsor

Source ClinicalTrials.gov
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