Sentinel Device to Prevent Stroke in Atrial Fibrillation

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

Recruiting N/A Interventional Study
Arrhythmia Atrial Fibrillation
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
48 (estimated)
Sponsor
Malini Madhavan · Other
Who this trial is looking for

This trial is looking for adults who are having a procedure called ablation for a heart condition known as atrial fibrillation. Participants will be monitored to see if using the Sentinel device can help prevent strokes during the procedure and how it affects thinking skills afterward.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am over 18 years old.
  • I am having an ablation procedure for atrial fibrillation.
  • I can provide informed consent.
  • I have acceptable blood vessel anatomy.

You may not be able to join if

  • I have had a stroke or mini-stroke in the past six months.
  • I have carotid disease needing treatment within six weeks.
  • I am pregnant.
  • I have a history of dementia.
  • I am allergic to nickel-titanium.
  • I have devices inside my body that are not compatible with MRI.
  • I have a blood clot in my heart.
  • I have a reversible cause for atrial fibrillation.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

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About This Trial

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.

Trial Locations
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Eligibility Criteria
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…
Contacts

Joseph Abdel Messih

507-422-3967

mansour.joseph@mayo.edu

CONTACT