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

Overview

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. Patients with MRI conditioned cardiac implantable electronic devices will also be excluded. This is done in light of concerns regarding patient safety in MRI scanner.
  • Inability to undergo MRI due to claustrophobia.
  • 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. 

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 B.S.

(507) 255-7072

Moscho.Andrew@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available