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Sentinel Device for Stroke Prevention During Atrial Fibrillation Ablation

This study is testing if a device called the Sentinel® Cerebral Protection System can help prevent strokes during a procedure called atrial fibrillation (AF) ablation. AF ablation is a treatment for an irregular heartbeat (arrhythmia). The Sentinel device is designed to catch and remove small pieces of debris that might break off during the procedure and travel to the brain. Researchers also want to see if this device affects your thinking and memory after the ablation. You may be able to join if you are over 18 and are having an AF ablation for symptomatic paroxysmal, persistent, or long-standing persistent AF that hasn't responded to other treatments. The study aims to enroll 48 participants. The study's success will be measured by how many participants experience brain injury, both noticeable and hidden, 7 and 90 days after the AF ablation. The current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 48 participants.
What's involved
If you receive the device, it will be placed in your heart at the start of your ablation and removed afterward. You will have a brain MRI before and 1 to 7 days after the ablation, a phone call 30 days after, and a final visit 90 days after for cognitive testing.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for 90 days after the ablation procedure to assess brain injury and cognitive function.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04685317

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

Recruiting
NAAges 18+InterventionalPrevention
Malini Madhavan
~48 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:Sentinel® Cerebral Protection SystemMagnetic Resonance Imaging

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incident of overt and covert CNS injury 7 days post AF ablation
Measured over 7 days post AF ablation
+1 more outcome measured

Conditions

Arrhythmia
Atrial Fibrillation

Explore related trials

Atrial Fibrillation

NCT04685317

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Mayo Clinic in Rochester

    Rochester, Minnesotastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Malini Madhavan, MBBS · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Joseph Abdel Messih
[email protected]
507-422-3967
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Incident of overt and covert CNS injury 7 days post AF ablation7 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

  • Incident of overt and covert CNS injury 90 days post AF ablation90 days post AF ablation

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