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RecruitingArrhythmiaAtrial Fibrillation

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

Eligible age

18+ yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

No

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About this study

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.

Sponsor: Malini Madhavan

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.

Where it's recruiting

Minnesota

Rochester

Source: ClinicalTrials.gov · NCT04685317 · last updated 2026-07-21

Safety and Efficacy of the Sentinel Cerebral Protection Device in Atri · TrialPath