Using a device to prevent strokes during heart procedures for atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and efficacy of the Sentinel® Cerebral Protection System in preventing strokes during ablation procedures for atrial fibrillation (AF). Participants will either receive the device or not during their procedure, and their cognitive function will be assessed 30 and 90 days post-procedure. The study aims to determine if the device reduces the occurrence of neurological events and improves cognitive outcomes compared to those who do not receive it.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Malini Madhavan, MBBS — Mayo Clinic
• Study coordinator: Joseph Abdel Messih
• Email: mansour.joseph@mayo.edu
• Phone: 507-422-3967

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.