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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Atrial Fibrillation; Arrhythmia
• Intervention / Treatment: Device: Sentinel® Cerebral Protection System; Diagnostic test: Magnetic Resonance Imaging

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 Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Men / women over the age of 18 years undergoing radiofrequency 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sentinel® Cerebral Protection System Group; Sentinel® Cerebral Protection System in patients undergoing AF catheter ablation	Device: Sentinel® Cerebral Protection System; A percutaneously delivered dual-filter protection device, designed to capture and remove debris dislodged during transcatheter aortic valve replacement procedures.; Diagnostic test: 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; Other Names: MRI
Active Comparator: Standard of Care Group; Standard of care (no cerebral protection device) in patients undergoing AF catheter ablation	Diagnostic test: 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; Other Names: MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incident of stroke / TIA 7 days post AF ablation	Incidence of stroke / TIA confirmed using physical examination and / or brain imaging during or within 7 days of the AF ablation	7 days post AF ablation
Incident of stroke / TIA 90 days post AF ablation	Incidence of stroke / TIA during or within 90 days of the AF ablation	90 days post AF ablation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
New cerebral infarcts	Total number of new cerebral infarcts in the protected territories detected on brain MRI after ablation in the Sentinel device group vs control group	day 1 to 7 after atrial fibrillation ablation
Change in neurocognitive function score	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.	Baseline, 90 days

Collaborators and Investigators

• Sponsor: Malini Madhavan

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2023
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: December 22, 2020
• First Submitted That Met QC Criteria: December 22, 2020
• First Posted (Actual): December 28, 2020

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 19-002836

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes