NCT05866640 Feasibility Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
| NCT ID | NCT05866640 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | EnCompass Technologies, Inc. |
| Condition | Aortic Stenosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2023-04-29 |
| Primary Completion | 2025-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2023-04-29 with a primary completion date of 2025-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: criteria: 1. Age ≥ 22 years. 2. The patient meets the established criteria and indications for commercially available TAVR (Edwards/Medtronic) for transfemoral access. 3. Montreal Cognitive Assessment (MoCA) score ≥ 26 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. 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. \-
Contact & Investigator
Francis Duhay, MD
STUDY DIRECTOR
Sponsor GmbH
Frequently Asked Questions
Who can join the NCT05866640 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Aortic Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05866640 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05866640 currently recruiting?
Yes, NCT05866640 is actively recruiting participants. Contact the research team at kcalderon@encompassf2.com for enrollment information.
Where is the NCT05866640 trial being conducted?
This trial is being conducted at Tbilisi, Georgia.
Who is sponsoring the NCT05866640 clinical trial?
NCT05866640 is sponsored by EnCompass Technologies, Inc.. The principal investigator is Francis Duhay, MD at Sponsor GmbH. The trial plans to enroll 10 participants.