NCT04685317 Safety and Efficacy of the Sentinel Cerebral Protection Device in Atrial Fibrillation Ablation
| NCT ID | NCT04685317 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Malini Madhavan |
| Condition | Arrhythmia |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2023-03-07 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 48 participants in total. It began in 2023-03-07 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Malini Madhavan, MBBS
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT04685317 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Arrhythmia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04685317 currently recruiting?
Yes, NCT04685317 is actively recruiting participants. Contact the research team at Purkey.Grace@mayo.edu for enrollment information.
Where is the NCT04685317 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT04685317 clinical trial?
NCT04685317 is sponsored by Malini Madhavan. The principal investigator is Malini Madhavan, MBBS at Mayo Clinic. The trial plans to enroll 48 participants.