Clinical Trials

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.