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

Launched by MALINI MADHAVAN · Dec 22, 2020

Keywords

ClinConnect Summary

This clinical trial is studying whether the Sentinel® Cerebral Protection System can help prevent strokes during a specific heart procedure called ablation for atrial fibrillation (AF), which is an irregular heartbeat. The trial also aims to see if using this device affects how well a person's thinking and memory function after the procedure compared to those who don’t use the device.

To join the study, participants need to be over 18 years old and scheduled for an ablation procedure for AF. They should be able to understand and agree to participate in the trial. Participants will undergo tests to ensure their blood vessels are suitable for the device. Throughout the trial, they will receive regular care and monitoring to ensure their safety. It's important to note that certain individuals, such as those with specific heart or brain conditions, or who are pregnant, may not be eligible to participate. This trial is currently looking for volunteers to help answer these important questions about improving safety during heart procedures.

Gender

ALL

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 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.