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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05893082




Registration number
NCT05893082
Ethics application status
Date submitted
23/05/2023
Date registered
7/06/2023
Date last updated
6/10/2023

Titles & IDs
Public title
Multicenter Feasibility Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Scientific title
A Prospective, Single-Arm, Multicenter Feasibility Trial to Evaluate the Safety and Performance of the F2 Filter and Delivery System Used for Embolic Protection During Transcatheter Aortic Valve Replacement
Secondary ID [1] 0 0
AS01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic Stenosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - F2 Filter and Delivery System

Experimental: Intervention - Placement of the F2 device in the aorta to cover the great cerebral vessels.


Treatment: Devices: F2 Filter and Delivery System
Placement of F2 device in aorta to cover the great cerebral vessels.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Major adverse cardiac and cerebrovascular events
Timepoint [1] 0 0
30 day
Secondary outcome [1] 0 0
New lesions
Timepoint [1] 0 0
8 - 72 hours
Secondary outcome [2] 0 0
Performance
Timepoint [2] 0 0
Intra-procedure
Secondary outcome [3] 0 0
Modified Rankin Scale
Timepoint [3] 0 0
30 day
Secondary outcome [4] 0 0
National Institute of Health Stroke Scale
Timepoint [4] 0 0
30 day
Secondary outcome [5] 0 0
Montreal Cognitive Assessment
Timepoint [5] 0 0
30 day

Eligibility
Key inclusion criteria
1. Age = 22 years.
2. The patient meets the established criteria and indications for commercially available TAVR (Edwards/Medtronic) for transfemoral access.
3. Modified Rankin Scale (mRS) 0 or 1 at screening.
4. The patient is willing and able to comply with protocol-specified follow-up evaluations.
5. The patient or legally authorized representative is able and willing to provide written informed consent.
Minimum age
22 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. 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).
2. Severe peripheral arterial, abdominal aortic, or thoracic aortic disease that precludes delivery sheath vascular access or filter deployment.
3. Patients in whom the aortic arch is heavily calcified, severely atheromatous, or severely tortuous.
4. Ascending aortic diameter > 38 mm or transverse aortic diameter > 27 mm.
5. Evidence of an acute myocardial infarction within 1 month before TAVR.
6. Pre-existing prosthetic heart valve or prosthetic ring in any position.
7. Known intracardiac thrombus.
8. 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.
9. History of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated.
10. Patients who refuse blood transfusion.
11. Active peptic ulcer or history of upper gastrointestinal (GI) bleeding within the prior 3 months.
12. Recent (within 6 months) CVA or a TIA.
13. Renal insufficiency (creatinine > 2.5 mg/dL or GFR < 30) and/or renal replacement therapy at the time of screening.
14. Patients with hepatic failure (Child-Pugh class C).
15. Patients with hypercoagulable states that cannot be corrected by additional periprocedural heparin.
16. Patients presenting with cardiogenic shock or requiring vasopressor or inotropic support at the time of the index procedure.
17. Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20%.
18. Life expectancy < 12 months.
19. 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).
20. Subjects who have had treatment with any other investigational device within 30 days prior to study enrollment.
21. Planned surgery or invasive procedure within 30 days following the index procedure (TAVR with F2 Filter).
22. 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.
23. 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.
24. 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.
25. Any other condition that in the opinion of the investigator, precludes study participation or poses a significant hazard to the patient.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/09/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2024
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
North Shore Private - Sydney
Recruitment postcode(s) [1] 0 0
2065 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
EnCompass Technologies, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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 undergoing a Transcatheter Aortic Valve replacement procedure.

Participants will complete several neurocognitive assessments and an MRI procedure.
Trial website
https://clinicaltrials.gov/study/NCT05893082
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Francis Duhay, MD
Address 0 0
Sponsor GmbH
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kathleen Calderon
Address 0 0
Country 0 0
Phone 0 0
307-250-2726
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05893082