Safety and Efficacy of the Sentinel Cerebral Protection Device in Atrial Fibrillation Ablation

Официальное название

A Pilot Randomized Study of the Use of The Sentinel Device for Cerebral Protection During Atrial Fibrillation Ablation

Обзор

The purpose of the study is to see if the Sentinel® Cerebral Protection System may prevent occurrence of stroke during an ablation procedure for atrial fibrillation (AF). The secondary purpose of this study is to study if cognitive function after AF ablation differs between those treated with the Sentinel cerebral protection device and those who do not receive the device.

Подробное описание

If assigned to receive the device, the Sentinel® Cerebral Protection System will be placed in your heart at the beginning of your ablation procedure, and then removed along with any collected blood debris upon completion of your procedure. The study team will then call you 30 days after your procedure to assess any neurological events. Your final visit will be 90 days after your procedure to complete a second 30 minute session of cognitive testing.

Вмешательства

• Устройство Sentinel® Cerebral Protection System
  A percutaneously delivered dual-filter protection device, designed to capture and remove debris dislodged during transcatheter aortic valve replacement procedures.
• Диагностический тест Magnetic Resonance Imaging
  Cerebral MRI will be performed without gadolinium contrast using a 3 Tesla scanner prior to and 1 to 7 days after catheter ablation

Первичные конечные точки

• Incident of overt and covert CNS injury 7 days post AF ablation [Срок оценки: 7 days post AF ablation]
• Incident of overt and covert CNS injury 90 days post AF ablation [Срок оценки: 90 days post AF ablation]

Вторичные конечные точки (2)

• Change in neurocognitive function score [Срок оценки: Baseline, 90 days]
• New cerebral infarcts [Срок оценки: day 1 to 7 after atrial fibrillation ablation]

Критерии участия

Критерии включения

• Men / women over the age of 18 years undergoing radiofrequency, pulsed field or cryo-balloon ablation for AF in accordance with the current AHA/ACC/HRS guideline for management of patients with atrial fibrillation. This includes patients with symptomatic paroxysmal, persistent or long-standing persistent AF not responsive to or intolerant of a Class I or III anti-arrhythmic drug or patients with symptomatic paroxysmal or persistent AF prior to the initiation of a Class I or Class III antiarrhythmic drug). The decision to perform catheter ablation for AF will be made by the treating provider and the patient in accordance with the guidelines noted above. (January et al. J Am Coll Cardiol vol. 64, No. 21, 2014, page e1)
• Able to provide informed consent.
• Patients should have acceptable aortic arch anatomy and vessel diameters without significant stenosis as assessed using pre-procedure CT angiogram.

Критерии исключения

• Anatomy unsuitable for use of Sentinel device:

• Right extremity vasculature not suitable due to compromised arterial blood flow.
• Brachiocephalic, left carotid or aortic arch not suitable due to excessive tortuosity, significant ectasia, stenosis (>70%), dissection or aneurysm.
• Cerebrovascular accident or transient ischemic attack within six months
• Carotid disease requiring treatment within six weeks
• Unable or unwilling to provide informed consent.
• Pregnant women
• Known history of dementia.
• Known hypersensitivity to nickel-titanium.
• Presence of MRI non-compatible implanted devices including cardiac implantable electronic devices.
• The presence of left atrial thrombus. All patients routinely undergo transesophageal echocardiogram prior to ablation and / or intra-cardiac echocardiogram at the beginning of the ablation procedure to rule out the presence of left atrial thrombus.
• Patients with a reversible cause for AF such as hyperthyroidism.

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

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Mayo Clinic in Rochester — Rochester

Идентификаторы

NCT: NCT04685317 · 19-002836

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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