Aortic Stenosis Treated With TAVISHIELDNCT06689839
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
A study testing F2 Filter and Delivery System and Transcatheter Aortic Valve Replacement (TAVR) in people with Aortic Stenosis Treated With TAVI and Aortic Diseases, run by EnCompass Technologies, Inc. at 10 sites in 2 countries.
Trial summary
The objective of this pivotal study is to compare the safety and effectiveness of the F2 CPC (Treatment group) to a Control group (no embolic protection) in participants undergoing transfemoral (TF) TAVR with commercially available devices. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Aortic Stenosis Treated With TAVI, Aortic Diseases
- What is being tested?
- F2 Filter and Delivery System and Transcatheter Aortic Valve Replacement (TAVR)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 9 Sep 2025to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 21 and ≤ 90 years
- Patient meets the established criteria and indications for commercially available TAVR (e.g., balloon expandable SAPIEN valve platform, self-expanding CoreValve platform, or Navitor TAVI System) via transfemoral access and is scheduled to undergo TAVR per their treating physician.
- Patient is willing and able to comply with protocol-specified follow-up evaluations.
- Patient is able and willing to provide written informed consent
Who cannot join
- General Exclusion Criteria:
- Participants are not eligible for the study if any of the following criteria are present:
- General Exclusion Criteria:
- Requires an urgent or emergent TAVR procedure.
- Any interventional cardiovascular procedure performed within 30 days prior to TAVR procedure (e.g., pacemaker placement, BAV, PCI) or planned within 30 days post-TAVR procedure.
- Current or planned participation in any investigational device/biopharma study during the duration of this study protocol.
Show all 42Show fewer
- Diagnostic cardiac catheterization within 10 days prior to TAVR procedure (Note: unplanned diagnostic catheterization is allowed during TAVR procedure, but must be performed prior to insertion of the investigational device into the vasculature).
- Concomitant non-valvular intervention, vascular intervention, or leaflet modification is planned at time of TAVR procedure. (Note: balloon aortic valvuloplasty during TAVR procedure is permitted).
- Evidence of an acute myocardial infarction within 3 months prior to TAVR procedure.
- Prior prosthetic heart valve in any position.
- Known intracardiac thrombus.
- Active infection or endocarditis.
- Severe allergy or known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel, nitinol, stainless steel alloy, nickel-titanium and/or contrast sensitivity that cannot be adequately pre-medicated.
- Presence or history of bleeding diathesis or coagulopathy.
- Contraindicated for anti-platelet and/or anticoagulant therapy.
- Refuses blood transfusion.
- Active peptic ulcer or history of upper gastrointestinal (GI) bleeding within the 3 months prior to TAVR procedure.
- Renal insufficiency (creatinine > 2.5 mg/dL or GFR < 30) and/or renal replacement therapy at the time of screening.
- Hepatic failure (Child-Pugh class C).
- Presenting with cardiogenic shock or requiring vasopressor or inotropic support, or with severe hypotension (systolic blood pressure < 90 mm Hg) at the time of randomization.
- Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) < 30%.
- Females who are pregnant or nursing or plan to become pregnant during their participation in the study. Female participants 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.
- Neurological Exclusion Criteria:
- Modified Rankin Scale (mRS) ≥ 2 at screening.
- Cerebrovascular event including TIA within 6 months of the procedure.
- Active major psychiatric disease, known mental or physical illness or known history of substance abuse that may cause non-compliance with the protocol or confound the data interpretation.
- Severe visual, auditory, or learning impairment.
- Neurodegenerative or other progressive neurological disease or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities.
- Note: use of general anesthesia during TAVR may affect neurocognitive function shortly after the procedure. While not an exclusion criterion, it is recommended that general anesthesia not be used, if possible.
- Magnetic Resonance Imaging Exclusion Criteria:
- Body Mass Index (BMI) precluding imaging in scanner.
- Contraindications to MRI (participants 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).
- High risk of complete AV block after TAVR, with the need of permanent pacemaker (e.g., patients with pre-existing bifascicular block or complete right bundle branch block plus any degree of AV block).
- Claustrophobia precluding MRI scanning.
- Anatomical and CT Exclusion Criteria:
- Severe peripheral arterial, abdominal aortic, or thoracic aortic disease that precludes delivery sheath, vascular access or filter deployment.
- Presence of cardiovascular implant in aorta and/or peripheral access vessels (e.g., thoracic endovascular aortic repair [TEVAR]/endovascular abdominal aortic aneurysm repair [EVAR], iliac/superficial femoral artery [SFA] stent).
- Access vessels with excessive tortuosity or complex anatomy that would likely necessitate a surgical cutdown approach (e.g., distance from skin to vessel is extensive).
- Aortic arch, which is heavily calcified, severely atheromatous, or severely tortuous.
- Ascending aortic diameter less than 18 mm or greater than 38 mm measured 6 to 8 cm from the annulus.
- Transverse aortic arch diameter less than 18 mm or greater than 27 mm when measured immediately proximal to the ostium of the left subclavian artery.
Trial locations and contacts
10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 2 countries
United States8 sites, 8 recruiting
- Not yet recruiting
University of Virginia Medical Center
Charlottesville, Virginia, 22903
Linda Bailes Bryceland, 434-982-1058, LGS2M@uvahealth.org
John Saxon
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Emily Tylicki, 216-287-8237, TYLICKE@ccf.org
Amar Krishnaswamy, MD
- Not yet recruiting
Ohio Health Research Institute (aka Riverside Methodist Hospital)
Columbus, Ohio, 43214
Maureen McCormack, (614) 788-3885, Maureen.McCormack@ohiohealth.com
Christina Belcher, 614-813-4555, christina.belcher@ohiohealth.com
- Recruiting
Henry Ford Hospital
Detroit, Michigan, 48202
Stephen Krafchak, 313-972-4018, skrafch1@hfhs.org
Sara Poggio, RN, 313-916-0119, spoggio1@hfhs.org
- Recruiting
St. Vincent Hospital
Indianappolis, Indiana, 46260
Kelly Verel, 317-338-8042, kelly.verel@ascension.org
James Hermiller, MD
- Recruiting
St. Lukes Hospital Of Kansas City
Kansas City, Missouri, 64111
Caroline Kempter, ckempter@saint-lukes.org
Anne Hoffman, 816-932-5707, ahoffman@saint-lukes.org
- Not yet recruiting
NCH Baker Hospital-Naples Heart Institute
Naples, Florida, 34102
Kathy Byrd, (239)624-8113
Robert Cubeddu
- Recruiting
Cumc/Nyph
New York, New York, 10032
Kate Dalton, 212-342-1820, keb2114@columbia.edu
Treena Williams, taw2112@columbia.edu
Australia2 sites, 2 recruiting
- Recruiting
Monash Health Public
Clayton, Victoria, 3168
Monique Farmer, monique.farmer@monashhealth.org
Robert Gooley, MD
- Not yet recruiting
St Andrews War Memorial Hospital
Spring Hill, Queensland, 4000
Linda Pearce, linda.pearce@wesleyresearch.org.au
Karl Poon, MD
About this study
Official title: A Prospective, Randomized, Multicenter, Single-blind Trial to Assess the Safety and Effectiveness of the Encompass F2 Cerebral Protection Catheter Vs. Unprotected Transfemoral Transcatheter Aortic Valve Replacement
The objective of this pivotal study is to compare the safety and effectiveness of the F2 CPC (Treatment group) to a Control group (no embolic protection) in participants undergoing transfemoral (TF) TAVR with commercially available devices.
Read the detailed description
The study is designed to demonstrate that the F2 CPC performs in a consistent manner as the control group in terms of safety, and the F2 Cerebral Protection Catheter (CPC) will be superior in performance when compared to the control group in terms of effectiveness in patients undergoing Transcatheter Aortic Valve Replacement (TF TAVR).
- Conditions
- Aortic Stenosis Treated With TAVI, Aortic Diseases
- Being tested
- F2 Filter and Delivery System, Transcatheter Aortic Valve Replacement (TAVR)
- Keywords
- Embolic Protection, Transcatheter Aortic Valve Replacement, TAVR, Aortic Valve Stenosis, Aortic Valve Diseases
- Medical subject headings
- Aortic Diseases, Aortic Valve Stenosis, Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F2 Filter and Delivery SystemDevice
Use of the F2 Filter and Delivery System in conjunction with a Transcatheter Aortic Valve Replacement (TAVR) procedure
Transcatheter Aortic Valve Replacement (TAVR)Procedure or surgery
Transcatheter Aortic Valve Replacement (TAVR) with commercially available Transcatheter Aortic Valve Replacement (TAVR) device
| Study group | Role | What they receive |
|---|---|---|
| F2 Filter and Delivery System | Experimental | The F2 Cerebral Embolic Protection System will be used during your Transcatheter Aortic Valve Replacement procedure. Receives: Device: F2 Filter and Delivery System; Procedure: Transcatheter Aortic Valve Replacement (TAVR) |
| No embolic protection device | Active comparator | No embolic protection device will be used during your Transcatheter Aortic Valve Replacement procedure. Receives: Procedure: Transcatheter Aortic Valve Replacement (TAVR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of the F2 CPC to provide neuroprotection during a TF TAVR procedure
Determined by pair-wise comparisons among participants in the eITT population (Finkelstein-Schoenfeld [FS] method) according to the following prespecified hierarchy of adverse outcomes:
- Ischemic stroke (disabling or non-disabling); evaluated through 72 hours post-procedure
- Total new lesion volume by DW-MRI; evaluated at 8-72 hours post-procedure by an independent MRI Core Laboratory.
Measured: 8 to 72 hours post procedure
Major Adverse Events (MAE)
Defined as the composite of the following components at 30 days:
- All-cause mortality
- All stroke (disabling and non-disabling)
- Acute kidney injury (Stage 3)
Measured: 30 days post procedure
Secondary outcomes (7)
Combined Safety and Efficacy - VARC-2
All-cause mortality; all stroke (disabling and non-disabling) and transient ischemic attack (TIA); acute kidney injury (stage 2 or 3, including renal replacement therapy)
Measured: Discharge or Day 5-10, whichever comes first
Neurological events (VARC-2 and NeuroARC)
Stroke (subclassified as ischemic, hemorrhagic, or undetermined, and as disabling or non-disabling); TIA
Measured: Discharge or Day 5-10, whichever comes first; Day 30
Incidence of acute kidney injury (AKIN)
Subclassified as stage 1, 2, or 3 Acute Kidney Injury (VARC-2)
Measured: Discharge or Day 5-10, whichever comes first; Day 30
Incidence of major vascular complications (VARC-3)
Measured: Discharge or Day 5-10, whichever comes first; Day 30
Bleeding
Incidence of life-threatening or disabling bleeding and major bleeding (VARC-2) - life-threatening or disabling bleeding; major bleeding
Measured: Discharge or Day 5-10, whichever comes first; Day 30
Major adverse embolic events (MAEE)
Incidence of the composite of all stroke (disabling or non-disabling) and transient ischemic attack (TIA), and Acute Kidney Injury Stage 2 or 3 (including renal replacement therapy), and systemic embolization
Measured: Discharge or Day 5-10
Total volume of new lesions by DW-MRI
Assessed by an independent MRI Core Laboratory
Measured: 8-72 hours post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start9 Sep 2025
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Stenosis Treated With TAVIStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in 1:1 ratio to: * Transcatheter Aortic Valve Replacement (TF TAVR) with the F2 Filter (CPC) (treatment group) or * No embolic protection (control group)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EnCompass Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- DP Clinical, Inc., Avania Pty Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06689839
- Sponsor's protocol ID
- ET03
- Acronym
- SHIELD
- Status last verified
- Nov 2025
- First submitted
- 1 Nov 2024
- Last updated
- 6 Nov 2026
- 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 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multicenter, Single-blind Trial to Assess the Safety and Effectiveness of the Encompass F2 Cerebral Protection Catheter Vs. Unprotected Transfemoral Transcatheter Aortic Valve Replacement
- ClinicalTrials.gov ID
- NCT06689839
- Acronym / sponsor ID
- SHIELD / ET03
- Conditions
- Aortic Stenosis Treated With TAVI, Aortic Diseases
- Keywords
- Embolic Protection, Transcatheter Aortic Valve Replacement, TAVR, Aortic Valve Stenosis, Aortic Valve Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- EnCompass Technologies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- DP Clinical, Inc., Avania Pty Ltd
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 15 Nov 2024 (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 objective of this pivotal study is to compare the safety and effectiveness of the F2 CPC (Treatment group) to a Control group (no embolic protection) in participants undergoing transfemoral (TF) TAVR with commercially available devices.
Detailed description
The study is designed to demonstrate that the F2 CPC performs in a consistent manner as the control group in terms of safety, and the F2 Cerebral Protection Catheter (CPC) will be superior in performance when compared to the control group in terms of effectiveness in patients undergoing Transcatheter Aortic Valve Replacement (TF TAVR).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in 1:1 ratio to: * Transcatheter Aortic Valve Replacement (TF TAVR) with the F2 Filter (CPC) (treatment group) or * No embolic protection (control group)
| Arm | Type | Receives |
|---|---|---|
| F2 Filter and Delivery System | Experimental | Device: F2 Filter and Delivery System, Procedure: Transcatheter Aortic Valve Replacement (TAVR)The F2 Cerebral Embolic Protection System will be used during your Transcatheter Aortic Valve Replacement procedure. |
| No embolic protection device | Active comparator | Procedure: Transcatheter Aortic Valve Replacement (TAVR)No embolic protection device will be used during your Transcatheter Aortic Valve Replacement procedure. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 21 and ≤ 90 years
- Patient meets the established criteria and indications for commercially available TAVR (e.g., balloon expandable SAPIEN valve platform, self-expanding CoreValve platform, or Navitor TAVI System) via transfemoral access and is scheduled to undergo TAVR per their treating physician.
- Patient is willing and able to comply with protocol-specified follow-up evaluations.
- Patient is able and willing to provide written informed consent
Key exclusion criteria (42 listed)
- Requires an urgent or emergent TAVR procedure.
- Any interventional cardiovascular procedure performed within 30 days prior to TAVR procedure (e.g., pacemaker placement, BAV, PCI) or planned within 30 days post-TAVR procedure.
- Current or planned participation in any investigational device/biopharma study during the duration of this study protocol.
- Diagnostic cardiac catheterization within 10 days prior to TAVR procedure (Note: unplanned diagnostic catheterization is allowed during TAVR procedure, but must be performed prior to insertion of the investigational device into the vasculature).
- Concomitant non-valvular intervention, vascular intervention, or leaflet modification is planned at time of TAVR procedure. (Note: balloon aortic valvuloplasty during TAVR procedure is permitted).
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 SystemUse of the F2 Filter and Delivery System in conjunction with a Transcatheter Aortic Valve Replacement (TAVR) procedure | Device | F2 Filter and Delivery System |
| Transcatheter Aortic Valve Replacement (TAVR)Transcatheter Aortic Valve Replacement (TAVR) with commercially available Transcatheter Aortic Valve Replacement (TAVR) device | Procedure or surgery | F2 Filter and Delivery System, No embolic protection device |
Primary outcome
Ability of the F2 CPC to provide neuroprotection during a TF TAVR procedure
Time frame: 8 to 72 hours post procedure
Determined by pair-wise comparisons among participants in the eITT population (Finkelstein-Schoenfeld [FS] method) according to the following prespecified hierarchy of adverse outcomes: * Ischemic stroke (disabling or non-disabling); evaluated through 72 hours post-procedure * Total new lesion volume by DW-MRI; evaluated at 8-72 hours post-procedure by an independent MRI Core Laboratory.
Major Adverse Events (MAE)
Time frame: 30 days post procedure
Defined as the composite of the following components at 30 days: * All-cause mortality * All stroke (disabling and non-disabling) * Acute kidney injury (Stage 3)
7 secondary outcomes
Combined Safety and Efficacy - VARC-2
Time frame: Discharge or Day 5-10, whichever comes first
Neurological events (VARC-2 and NeuroARC)
Time frame: Discharge or Day 5-10, whichever comes first; Day 30
Incidence of acute kidney injury (AKIN)
Time frame: Discharge or Day 5-10, whichever comes first; Day 30
Incidence of major vascular complications (VARC-3)
Time frame: Discharge or Day 5-10, whichever comes first; Day 30
Bleeding
Time frame: Discharge or Day 5-10, whichever comes first; Day 30
Major adverse embolic events (MAEE)
Time frame: Discharge or Day 5-10
Total volume of new lesions by DW-MRI
Time frame: 8-72 hours post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Aortic Stenosis Treated With TAVI
Not yet recruitingObservational study
Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation
Aortic Stenosis, Mitral Regurgitation
Active, not recruitingObservational study
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Aortic Valve Stenosis
Not yet recruiting
High Flow Nasal Oxygenation in Transcatheter Aortic Valve Replacement Procedures. TAVR-Highflow II
Aortic Stenosis Treated With TAVI, Sedation; Aged; Hemodynamics
Enrolling by invitation
Transfemoral TAVI With or Without Coronary Angiogram in Patients With Severe Aortic Stenosis (PURE TAVI)
Severe Aortic Stenosis
RecruitingPhase 4
Single Antiplatelet Treatment With Ticagrelor or Aspirin After Transcatheter Aortic Valve Implantation
Severe Aortic Valve Stenosis, Aortic Valve Stenosis
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.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing F2 Filter and Delivery System and Transcatheter Aortic Valve Replacement (TAVR) in people with Aortic Stenosis Treated With TAVI and Aortic Diseases, run by EnCompass Technologies, Inc. at 10 sites in 2 countries.
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 4 inclusion and 42 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: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandra Show (7142928652, sshow@encompassf2.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability of the F2 CPC to provide neuroprotection during a TF TAVR procedure (time frame: 8 to 72 hours post procedure). The study lists 2 primary outcomes in all. 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 6 Nov 2026.