Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR (SHIELD)

A Prospective, Randomized, Multicenter, Single-blind Trial to Assess the Safety and Effectiveness of the Encompass F2 Cerebral Protection System Vs. Standard of Care (Unprotected or Sentinel® Cerebral Protection System) During Transfemoral Transcatheter Aortic Valve Replacement

The objective of this study is to compare the safety and effectiveness of the F2 Cerebral Protection System (CPS) to a standard of care control group in patients undergoing Transcatheter Aortic Valve Replacement (TF TAVR)

Study Overview

• Status: Recruiting
• Conditions: Aortic Diseases; Aortic Stenosis Treated With TAVI
• Intervention / Treatment: Device: F2 Filter and Delivery System; Procedure: Transcatheter Aortic Valve Replacement (TAVR)

Detailed Description

The study is designed to demonstrate that the F2 Cerebral Protection System (CPS) performs in a consistent manner as the control group in terms of safety, and the F2 Cerebral Protection System (CPS) 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 Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kathleen S Calderon; Phone Number: 3072502726; Email: kcalderon@encompassf2.com

Study Locations

• Australia
  • Queensland
    • Spring Hill, Queensland, Australia, 4000
      • Not yet recruiting
      • St Andrews War Memorial Hospital
      • Contact: Linda Pearce; Email: linda.pearce@wesleyresearch.org.au
      • Principal Investigator: Karl Poon, MD
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Recruiting
      • Monash Health Public
      • Principal Investigator: Robert Gooley, MD
      • Contact: Trazzie Luk; Email: TszTing.Luk@monashhealth.org
• United States
  • Florida
    • Naples, Florida, United States, 34102
      • Not yet recruiting
      • NCH Baker Hospital-Naples Heart Institute
      • Contact: Kathy Byrd; Phone Number: (239)624-8113
      • Principal Investigator: Robert Cubeddu
  • Indiana
    • Indianappolis, Indiana, United States, 46260
      • Recruiting
      • St. Vincent Hospital
      • Principal Investigator: James Hermiller, MD
      • Contact: Kelly Verel; Phone Number: 317-338-8042; Email: kelly.verel@ascension.org
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford Hospital
      • Principal Investigator: Brian O'Neill, MD
      • Contact: Stephen Krafchak; Phone Number: 313-972-4018; Email: skrafch1@hfhs.org
      • Contact: Sara Poggio, RN; Phone Number: 313-916-0119; Email: spoggio1@hfhs.org
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Recruiting
      • St. Lukes Hospital of Kansas City
      • Contact: Caroline Kempter; Email: ckempter@saint-lukes.org
      • Contact: Anne Hoffman; Phone Number: 816-932-5707; Email: ahoffman@saint-lukes.org
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Cumc/Nyph
      • Contact: Kate Dalton; Phone Number: 212-342-1820; Email: keb2114@columbia.edu
      • Contact: Treena Williams; Email: taw2112@columbia.edu
      • Principal Investigator: Torsten Vahl, MD
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic Foundation
      • Principal Investigator: Amar Krishnaswamy, MD
      • Contact: Emily Tylicki; Phone Number: 216-287-8237; Email: TYLICKE@ccf.org
    • Columbus, Ohio, United States, 43214
      • Not yet recruiting
      • Ohio Health Research Institute (aka Riverside Methodist Hospital)
      • Principal Investigator: Steven Yakubov, MD
      • Contact: Christina Belcher; Phone Number: 614-813-4555; Email: christina.belcher@ohiohealth.com
      • Contact: Maureen McCormack; Phone Number: (614) 788-3885; Email: Maureen.McCormack@ohiohealth.com
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Not yet recruiting
      • University of Virginia Medical Center
      • Contact: Linda Bailes Bryceland; Phone Number: 434-982-1058; Email: LGS2M@uvahealth.org
      • Principal Investigator: John Saxon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Age ≥ 50 years.
• Patient meets the established criteria and indications for commercially available TAVR 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.
• Patient meets all criteria for use of control device (Sentinel device, per IFU).

Key Exclusion Criteria:

General Exclusion Criteria:

• Patient requires an urgent or emergent TAVR procedure.
• Any interventional cardiovascular procedure performed within 30 days prior to TAVR procedure or planned within 30 days post-TAVR procedure.
• Diagnostic cardiac catheterization within 10 days prior to TAVR procedure.
• 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.
• Patient is contraindicated for anti-platelet and/or anticoagulant therapy.
• Patient refuses blood transfusion.
• 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).
• 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.

Neurological Exclusion Criteria:

• Modified Rankin Scale (mRS) ≥ 2 at screening.
• Cerebrovascular event including TIA within 6 months of the procedure.
• Patient has 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.
• Patient has severe visual, auditory, or learning impairment.
• Patient has neurodegenerative or other progressive neurological disease or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities.

Magnetic Resonance Imaging Exclusion Criteria:

• 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.
• 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.
• Access vessels with excessive tortuosity.
• Aortic arch, which is heavily calcified, severely atheromatous, or severely tortuous.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: F2 Filter and Delivery System; The F2 Cerebral Embolic Protection System will be used during your Transcatheter Aortic Valve Replacement procedure	Device: F2 Filter and Delivery System; Use of the F2 Filter and Delivery System in conjunction with a Transcatheter Aortic Valve Replacement (TAVR) procedure; Procedure: Transcatheter Aortic Valve Replacement (TAVR); Transcatheter Aortic Valve Replacement (TAVR) with commercially available Transcatheter Aortic Valve Replacement (TAVR) device
Active Comparator: Either the Sentinel Cerebral Protection System or no embolic protection device; Either the Sentinel Cerebral Protection System or no embolic protection device will be used during your Transcatheter Aortic Valve Replacement procedure depending on the Standard of Care at the treating institution	Procedure: Transcatheter Aortic Valve Replacement (TAVR); Transcatheter Aortic Valve Replacement (TAVR) with commercially available Transcatheter Aortic Valve Replacement (TAVR) device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Cardiac and Cerebrovascular Events (MACCE)	MACCE includes the composite of death, all stroke, acute kidney injury (AKI) stage 3 or 4 within 7 days post-index procedure Valve Academic Research Consortium 3 (VARC-3) and any major vascular complication (VARC-3)	30 days post procedure
Total New Lesion Volume	Total new lesion volume (TNLV) in the brain assessed by diffusion weighted magnetic resonance images (DW-MRI)	8-72 hours post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke	Incidence of all stroke events	30 days post procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	During procedure
Mortality & Stroke Rates	Incidences of all-cause mortality, major stroke, minor stroke events	30 days post procedure
Freedom from Lesions	Measure presence or absence of new lesions in the brain, assessed by diffusion weighted magnetic resonance images (DW-MRI)	8-72 hours post procedure
Average Lesion Size	Measure average lesion size in the brain, assessed by diffusion weighted magnetic resonance images (DW-MRI)	8-72 hours post procedure
Neurological Outcomes-Montreal Cognitive Assessment (MoCA)	Use Montreal Cognitive Assessment (MoCA) to measure cognitive impairment on a scale of 0-30 (high score is better outcome).	30 days post procedure
Neurological Outcomes-Modified Rankin Scale (MRS)	Use Modified Rankin Scale (MRS) to measure neurological disability on scale of 0-6 (Low score is better outcome)	30 days post procedure
Major Vascular Complication & Bleeding	Measure major vascular complications (as defined by VARC-3) & major bleeding (Type 3, Type 4 as defined by VARC- 3)	During procedure
Hospital Readmissions	Measure number of hospital readmissions at 30 days and number of ICU readmissions during hospital stay and 30 days	30 days post procedure
Index Hospital Length of Stay (LOS)	Measure Index hospitalization LOS	Through 30 days
Index Hospitalization ICU Length of Stay (LOS)	Measure Index hospitalization ICU length of stay	Through 30 days
Kansas City Cardiomyopathy Questionnaire (KCCQ)	The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a self-reported questionnaire that measures physical function, symptoms, social function, and quality of life, on a scale from 0 to 100 (higher score is better outcome).	30 days post procedure
Short Form (SF-12) Questionnaire	The Short Form (SF-12) Questionnaire is a self-reported questionnaire that assess the impact of health on an individual's everyday life, on a scale from 0 to 100 (higher score is better health).	30 days post procedure
Neurological Outcomes-National Institute of Health Stroke Scale (NIHSS)	Use National Institute of Health Stroke Scale (NIHSS) to measure stroke severity on a scale of 0-41 (low score is better outcome).	30 days post procedure

Collaborators and Investigators

• Sponsor: EnCompass Technologies, Inc.
• Collaborators: Avania; Insight Medical Consulting

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: November 1, 2024
• First Submitted That Met QC Criteria: November 8, 2024
• First Posted (Actual): November 15, 2024

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Aortic Valve Stenosis; Transcatheter Aortic Valve Replacement; TAVR; Embolic Protection; Aortic Valve Diseases
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Disease; Aortic Valve Stenosis; Aortic Diseases; Surgical Procedures, Operative; Cardiovascular Surgical Procedures; Cardiac Surgical Procedures; Thoracic Surgical Procedures; Prosthesis Implantation; Heart Valve Prosthesis Implantation; Transcatheter Aortic Valve Replacement
• Other Study ID Numbers: ET03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes