NCT04685317Recruiting
Safety and Efficacy of the Sentinel Cerebral Protection Device in Atrial Fibrillation Ablation
A Pilot Randomized Study of the Use of The Sentinel Device for Cerebral Protection During Atrial Fibrillation Ablation
Source: ClinicalTrials.gov · Last updated 21 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- First submitted
- 22 Dec 2020
- Start date
- 7 Mar 2023
- Primary completion date
- Jun 2027
- Lead sponsor
- Malini Madhavan
- Diseases
- Atrial fibrillation
- NCT number
- NCT04685317
What you commit to
- Study type: Interventional
- Planned participants: 48
- From 7 Mar 2023 to the primary completion date, Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Carotid disease requiring treatment within six weeks
- Known history of dementia.
- Known hypersensitivity to nickel-titanium.
- Presence of MRI non-compatible implanted devices including cardiac implantable electronic devices.
Other
- 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
- Unable or unwilling to provide informed consent.
- Pregnant women
- Patients with a reversible cause for AF such as hyperthyroidism.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.