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

NCT04685317 | Recruiting DMC FDA Device

• 1 other identifier: 19-002836
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Arrhythmia; Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Incident of overt and covert CNS injury 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

  7 days post AF ablation

• Incident of overt and covert CNS injury 90 days post AF ablation

  Incidence of overt and covert CNS injury during or within 90 days of the AF ablation

  90 days post AF ablation

Secondary Outcomes (2)

• Change in neurocognitive function score

  Baseline, 90 days

• New cerebral infarcts

  day 1 to 7 after atrial fibrillation ablation

Study Arms (2)

Sentinel® Cerebral Protection System Group

EXPERIMENTAL

Sentinel® Cerebral Protection System in patients undergoing AF catheter ablation

Device: Sentinel® Cerebral Protection System; Diagnostic Test: Magnetic Resonance Imaging

Standard of Care Group

ACTIVE COMPARATOR

Standard of care (no cerebral protection device) in patients undergoing AF catheter ablation

Diagnostic Test: Magnetic Resonance Imaging

Interventions

Sentinel® Cerebral Protection System DEVICE

A percutaneously delivered dual-filter protection device, designed to capture and remove debris dislodged during transcatheter aortic valve replacement procedures.

Sentinel® Cerebral Protection System Group

Magnetic Resonance Imaging DIAGNOSTIC_TEST

Cerebral MRI will be performed without gadolinium contrast using a 3 Tesla scanner prior to and 1 to 7 days after catheter ablation

Also known as: MRI

Sentinel® Cerebral Protection System Group; Standard of Care Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Malini Madhavan: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Arrhythmias, Cardiac; Atrial Fibrillation

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Malini Madhavan, MBBS

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Grace Purkey

CONTACT

(507) 255-0774; Purkey.Grace@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized study of Sentinel cerebral protection device vs no cerebral protection device in patients undergoing atrial fibrillation ablation.

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 28, 2020
• Study Start: March 7, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 11, 2025

Record last verified: 2025-06

Locations

US (1)