A Study to Evaluate the Use of The Sentinel Device During Atrial Fibrillation Ablation


About this study

The purpose of this study is to compare the Sentinel® Cerebral Protection System to the standard of care (no cerebral protection) in patients undergoing atrial fibrillation (AF) catheter ablation.


Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Men / women over the age of 18 years undergoing radiofrequency 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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 9/7/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Malini Madhavan, M.B.B.S.

Open for enrollment

Contact information:

Andrew Moscho

(507) 255-7072


More information


Publications are currently not available

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