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

Launched by ENCOMPASS TECHNOLOGIES, INC. · Nov 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the F2 Cerebral Protection System, which is designed to help protect the brain during a procedure known as Transcatheter Aortic Valve Replacement (TAVR). TAVR is a minimally invasive surgery used to treat a heart condition called aortic stenosis, where the aortic valve becomes narrowed and restricts blood flow. The trial aims to compare the safety and effectiveness of the F2 device to standard care, helping doctors understand if it can provide better protection for patients during the procedure.

To participate in the trial, potential candidates should be at least 50 years old and scheduled to undergo TAVR. They must be able to follow study guidelines and provide written consent. However, some individuals may not qualify if they need urgent surgery, have certain heart conditions, or have had other recent procedures that could affect their safety during TAVR. If you or a loved one are considering this trial, you can expect close monitoring and follow-up evaluations to ensure safety and gather important information about the device's performance. The trial is not yet recruiting participants, but it represents an important step in improving care for patients undergoing TAVR.

Gender

ALL

Eligibility criteria

• 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.