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

Not Applicable

Recruiting

• Conditions: Atrial Fibrillation; Arrhythmia
• Interventions: Device: Sentinel® Cerebral Protection System; Diagnostic Test: Magnetic Resonance Imaging

• Registration Number: NCT04685317
• Lead Sponsor: Malini Madhavan

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-12-22
• Study First Submitted QC: 2020-12-22
• Study First Posted: 2020-12-28
• Study Start: 2023-03-07
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-21
• Last Update Posted: 2024-05-23
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sentinel® Cerebral Protection System Group	Magnetic Resonance Imaging	Sentinel® Cerebral Protection System in patients undergoing AF catheter ablation
Standard of Care Group	Magnetic Resonance Imaging	Standard of care (no cerebral protection device) in patients undergoing AF catheter ablation
Sentinel® Cerebral Protection System Group	Sentinel® Cerebral Protection System	Sentinel® Cerebral Protection System in patients undergoing AF catheter ablation

Primary Outcome Measures

Name	Time	Method
Incident of overt and covert CNS injury 90 days post AF ablation	90 days post AF ablation	Incidence of overt and covert CNS injury during or within 90 days of the AF ablation
Incident of overt and covert CNS injury 7 days post AF ablation	7 days post AF ablation	Incidence of overt and covert CNS injury confirmed using physical examination and / or brain imaging during or within 7 days of the AF ablation

Secondary Outcome Measures

Name	Time	Method
Change in neurocognitive function score	Baseline, 90 days	Montreal cognitive assessment will administered at baseline and 90 days following ablation. Change in cognitive function score will be compared between the groups. The score ranges from 0 to 30 with higher score indicating better cognitive performance.
New cerebral infarcts	day 1 to 7 after atrial fibrillation ablation	Total number of new cerebral infarcts in the protected territories detected on brain MRI after ablation in the Sentinel device group vs control group

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States