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

Primary Purpose

Aortic Stenosis

Status
Recruiting
Phase
Early Phase 1
Locations
Georgia
Study Type
Interventional
Intervention
F2 filter and delivery system
Sponsored by
EnCompass Technologies, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Aortic Stenosis focused on measuring TAVR

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: criteria: 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. 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. -

Sites / Locations

  • HealthycoreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Placement of the F2 device in the aorta to cover the great cerebral vessels.

Outcomes

Primary Outcome Measures

Major adverse cardiac and cerebrovascular events
Major adverse cardiac and cerebrovascular events

Secondary Outcome Measures

New lesions
total new lesion volume, average individual new lesion volume, number of new lesions, location of new lesions, territory of new lesions
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)
Modified Rankin Scale
Measures neurological disability on scale of 0-6 (low score is better outcome)
National Institute of Health Stroke Scale
Measures stroke severity on scale of 0 - 42 (low score is better outcome)
Montreal Cognitive Assessment
Measures cognitive impairment on scale of 0 - 30 (high score is better outcome)

Full Information

First Posted
May 8, 2023
Last Updated
October 4, 2023
Sponsor
EnCompass Technologies, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05866640
Brief Title
Feasibility Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Official Title
A Prospective, Single-Arm, Single Center Feasibility Trial to Evaluate the Safety and Performance of the F2 Filter and Delivery System Used for Embolic Protection During Transcatheter Aortic Valve Replacement
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 29, 2023 (Actual)
Primary Completion Date
January 30, 2024 (Anticipated)
Study Completion Date
January 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EnCompass Technologies, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Stenosis
Keywords
TAVR

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Placement of the F2 device in the aorta to cover the great cerebral vessels.
Intervention Type
Device
Intervention Name(s)
F2 filter and delivery system
Intervention Description
Placement of F2 device in aorta to cover great cerebral vessels
Primary Outcome Measure Information:
Title
Major adverse cardiac and cerebrovascular events
Description
Major adverse cardiac and cerebrovascular events
Time Frame
30 days
Secondary Outcome Measure Information:
Title
New lesions
Description
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
Title
Performance
Description
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
Title
Modified Rankin Scale
Description
Measures neurological disability on scale of 0-6 (low score is better outcome)
Time Frame
30 day
Title
National Institute of Health Stroke Scale
Description
Measures stroke severity on scale of 0 - 42 (low score is better outcome)
Time Frame
30 day
Title
Montreal Cognitive Assessment
Description
Measures cognitive impairment on scale of 0 - 30 (high score is better outcome)
Time Frame
30 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: criteria: 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. 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. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kathleen Calderon
Phone
307-250-2726
Email
kcalderon@encompassf2.com
First Name & Middle Initial & Last Name or Official Title & Degree
Francis Duhay, MD
Phone
949-285-8170
Email
fduhay@encompassf2.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francis Duhay, MD
Organizational Affiliation
Sponsor GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Healthycore
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irakli Gogorishvili, MD
Phone
+995322433343
Email
Gogorishvili@gmail.com
First Name & Middle Initial & Last Name & Degree
Irakli Gogorishvili, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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