Safety and Efficacy of the Sentinel Cerebral Protection Device in Atrial Fibrillation Ablation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMalini Madhavan
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Sentinel® Cerebral Protection System
- Magnetic Resonance Imaging
Treatment groups
48 Participants
are divided into 2 treatment groupsSponsors and collaborators
Malini Madhavan
Lead sponsor
Mayo Clinic
Sponsor institution
Source ClinicalTrials.gov