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Multicenter Feasibility Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR

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Study details:

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 undergoing a Transcatheter Aortic Valve replacement procedure. The F2 device is inserted via a transfemoral approach and positioned in the aorta to cover and protect the three great cerebral vessels from any debris released during the valve replacement procedure. The F2 device remains in place during the aortic valve replacement procedure.

After the valve is placed, the F2 device is removed.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Age ≥ 22 years.

The patient meets the established criteria and indications for commercially available TAVR (Edwards/Medtronic) for transfemoral access.

Modified Rankin Scale (mRS) 0 or 1 at screening.

The patient is willing and able to comply with protocol-specified follow-up evaluations.

The patient or legally authorized representative is able and willing to provide written informed consent.

Exclusion criteria

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.

Evidence of an acute myocardial infarction within 1 month before TAVR.

Pre-existing prosthetic heart valve or prosthetic ring in any position.

Known intracardiac thrombus.

Severe allergy or known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel, nitinol, stainless steel alloy, and/or contrast sensitivity that cannot be adequately pre-medicated.

History of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated.

Patients who refuse blood transfusion.

Active peptic ulcer or history of upper gastrointestinal (GI) bleeding within the prior 3 months.

Recent (within 6 months) CVA or a TIA.

Renal insufficiency (creatinine > 2.5 mg/dL or GFR < 30) and/or renal replacement therapy at the time of screening.

Patients with hepatic failure (Child-Pugh class C).

Patients with hypercoagulable states that cannot be corrected by additional periprocedural heparin.

Patients presenting with cardiogenic shock or requiring vasopressor or inotropic support at the time of the index procedure.

Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20%.

Life expectancy < 12 months.

Currently participating in an investigational drug or another device study that has not completed the initial primary endpoint evaluation (e.g., long term follow-up study/continued access study subjects are able to be included).

Subjects who have had treatment with any other investigational device within 30 days prior to study enrollment.

Planned surgery or invasive procedure within 30 days following the index procedure (TAVR with F2 Filter).

Patients planned to undergo any other cardiac surgical or interventional procedure (e.g., concurrent coronary revascularization) during the TAVR procedure or within 10 days prior to the TAVR procedure. NOTE: Balloon valvuloplasty during TAVR is permitted. Diagnostic cardiac catheterization is permitted within 10 days prior to the TAVR procedure.

Patients with known mental or physical illness or known history of substance abuse that may cause non-compliance with the protocol or confound the data interpretation.

Females who are pregnant or nursing or plan to become pregnant during their participation in the study. Female subjects of child-bearing potential must have a negative pregnancy test at screening.

Any other condition that in the opinion of the investigator, precludes study participation or poses a significant hazard to the patient.

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Eligibility

Age eligible for study : 22 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-09-12

Primary completion: 2023-12-01

Study completion finish: 2024-01-01

Study type

TREATMENT

Phase

Trial ID

NCT05893082

Intervention or treatment

DEVICE: F2 Filter and Delivery System

Conditions

• Aortic Stenosis

Condition: Aortic Stenosis
DEVICE: F2 Filter and Delivery System
Sydney, New South Wales, Australia
Sponsor: EnCompass Technologies, Inc.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

North Shore Private

Research sites nearby

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North Shore Private
Sydney, New South Wales, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Intervention Placement of the F2 device in the aorta to cover the great cerebral vessels.	DEVICE: F2 Filter and Delivery System Placement of F2 device in aorta to cover the great cerebral vessels.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Major adverse cardiac and cerebrovascular events	Major adverse cardiac and cerebrovascular events	30 day

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
New lesions	Total new lesion volume, average individual new lesion volume, number of new lesions, location of new lesions, territory of new lesions.	8 - 72 hours
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)	Intra-procedure
Modified Rankin Scale	Measures neurological disability on scale of 0-6 (low score is better outcome)	30 day
National Institute of Health Stroke Scale	Measures stroke severity on scale of 0-42 (low score is better outcome)	30 day
Montreal Cognitive Assessment	Measures cognitive impairment on scale of 0-30( high score is better outcome)	30 day

Frequently Asked Questions

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References

Clinical Trials Gov: Multicenter Feasibility Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR