Using a device to prevent strokes during heart procedures for atrial fibrillation
A Pilot Randomized Study of the Use of The Sentinel Device for Cerebral Protection During Atrial Fibrillation Ablation
This study tests whether a special device can help prevent strokes during heart procedures for people with atrial fibrillation and see if it improves their thinking skills afterward.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT04685317 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of the Sentinel® Cerebral Protection System in preventing strokes during ablation procedures for atrial fibrillation (AF). Participants will either receive the device or not during their procedure, and their cognitive function will be assessed 30 and 90 days post-procedure. The study aims to determine if the device reduces the occurrence of neurological events and improves cognitive outcomes compared to those who do not receive it.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 undergoing ablation for symptomatic atrial fibrillation who can provide informed consent.
Not a fit: Patients with unsuitable anatomy for the Sentinel device or those not undergoing ablation for atrial fibrillation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of stroke during atrial fibrillation ablation procedures.
How similar studies have performed: Other studies have explored similar protective devices in cardiac procedures, showing promising results, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Malini Madhavan, MBBS — Mayo Clinic
- Study coordinator: Grace Purkey
- Email: Purkey.Grace@mayo.edu
- Phone: (507) 255-0774
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.