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

Официальное название

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

Обзор

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)

Подробное описание

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).

Вмешательства

• Устройство F2 Filter and Delivery System
  Use of the F2 Filter and Delivery System in conjunction with a Transcatheter Aortic Valve Replacement (TAVR) procedure
• Процедура Transcatheter Aortic Valve Replacement (TAVR)
  Transcatheter Aortic Valve Replacement (TAVR) with commercially available Transcatheter Aortic Valve Replacement (TAVR) device

Первичные конечные точки

• Major Adverse Cardiac and Cerebrovascular Events (MACCE) [Срок оценки: 30 days post procedure]
• Total New Lesion Volume [Срок оценки: 8-72 hours post procedure]

Вторичные конечные точки (1)

• Stroke [Срок оценки: 30 days post procedure]

Критерии участия

Критерии включения

• 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).

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 8 центров

• NCH Baker Hospital-Naples Heart Institute — Naples
• St. Vincent Hospital — Indianappolis
• Henry Ford Hospital — Detroit
• St. Lukes Hospital Of Kansas City — Kansas City
• Cumc/Nyph — New York
• Cleveland Clinic Foundation — Cleveland
• Ohio Health Research Institute (aka Riverside Methodist Hospital) — Columbus
• University of Virginia Medical Center — Charlottesville

Австралия · 2 центра

• St Andrews War Memorial Hospital — Spring Hill
• Monash Health Public — Clayton

Идентификаторы

NCT: NCT06689839 · ET03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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