Aortic StenosisNCT05893082
Multicenter Feasibility Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
A study testing F2 Filter and Delivery System in people with Aortic Stenosis, run by EnCompass Technologies, Inc. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- F2 Filter and Delivery System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteAustralia
- Study dates
- 12 Sep 2023to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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 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.
- Conditions
- Aortic Stenosis
- Being tested
- F2 Filter and Delivery System
- Keywords
- TAVR
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F2 Filter and Delivery SystemDevice
Placement of F2 device in aorta to cover the great cerebral vessels.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Placement of the F2 device in the aorta to cover the great cerebral vessels. Receives: Device: F2 Filter and Delivery System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac and cerebrovascular events
Major adverse cardiac and cerebrovascular events
Measured: 30 day
Secondary outcomes (5)
New lesions
Total new lesion volume, average individual new lesion volume, number of new lesions, location of new lesions, territory of new lesions.
Measured: 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)
Measured: Intra-procedure
Modified Rankin Scale
Measures neurological disability on scale of 0-6 (low score is better outcome)
Measured: 30 day
National Institute of Health Stroke Scale
Measures stroke severity on scale of 0-42 (low score is better outcome)
Measured: 30 day
Montreal Cognitive Assessment
Measures cognitive impairment on scale of 0-30( high score is better outcome)
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start12 Sep 2023
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- EnCompass Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francis Duhay, MD, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05893082
- Sponsor's protocol ID
- AS01
- Status last verified
- Feb 2025
- First submitted
- 23 May 2023
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05893082
- Acronym / sponsor ID
- AS01
- Conditions
- Aortic Stenosis
- Keywords
- TAVR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- EnCompass Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: F2 Filter and Delivery SystemPlacement of the F2 device in the aorta to cover the great cerebral vessels. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| F2 Filter and Delivery SystemPlacement of F2 device in aorta to cover the great cerebral vessels. | Device | Intervention |
Primary outcome
Major adverse cardiac and cerebrovascular events
Time frame: 30 day
Major adverse cardiac and cerebrovascular events
5 secondary outcomes
New lesions
Time frame: 8 - 72 hours
Performance
Time frame: Intra-procedure
Modified Rankin Scale
Time frame: 30 day
National Institute of Health Stroke Scale
Time frame: 30 day
Montreal Cognitive Assessment
Time frame: 30 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francis Duhay, MD study director
Sponsor GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing F2 Filter and Delivery System in people with Aortic Stenosis, run by EnCompass Technologies, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac and cerebrovascular events (time frame: 30 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.