NCT05866640

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Apr 2023

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 29, 2023

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 19, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

2.7 years

First QC Date

May 8, 2023

Last Update Submit

February 24, 2025

Conditions

Aortic Stenosis

Keywords

TAVR

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiac and cerebrovascular events

    Major adverse cardiac and cerebrovascular events

    30 days

Secondary Outcomes (5)

  • New lesions

    8-72 hours

  • Performance

    intra-procedure

  • Modified Rankin Scale

    30 day

  • National Institute of Health Stroke Scale

    30 day

  • Montreal Cognitive Assessment

    30 day

Study Arms (1)

Intervention

EXPERIMENTAL

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

Device: F2 filter and delivery system

Interventions

F2 filter and delivery systemDEVICE

Placement of F2 device in aorta to cover great cerebral vessels

Intervention

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Healthycore

Tbilisi, 0112, Georgia

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Francis Duhay, MD

    Sponsor GmbH

    STUDY DIRECTOR

Central Study Contacts

Kathleen Calderon

CONTACT

307-250-2726kcalderon@encompassf2.com

Francis Duhay, MD

CONTACT

949-285-8170fduhay@encompassf2.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2023

First Posted

May 19, 2023

Study Start

April 29, 2023

Primary Completion

December 30, 2025

Study Completion

January 30, 2026

Last Updated

February 25, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

GE(1)