Recruiting

Sentinel Device

Sponsor:

Malini Madhavan

Code:

NCT04685317

Conditions

Arrhythmia

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sentinel® Cerebral Protection System

Magnetic Resonance Imaging

Study Details

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.

Conditions

Arrhythmia

Atrial Fibrillation

Study ID

NCT04685317

Start date

Mar 7, 2023

Status verified date

Jun, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Sentinel® Cerebral Protection System Group

Sentinel® Cerebral Protection System in patients undergoing AF catheter ablation

active comparator: Standard of Care Group

Standard of care (no cerebral protection device) in patients undergoing AF catheter ablation

Interventions

Sentinel® Cerebral Protection System

A percutaneously delivered dual-filter protection device, designed to capture and remove debris dislodged during transcatheter aortic valve replacement procedures.

Magnetic Resonance Imaging

Cerebral MRI will be performed without gadolinium contrast using a 3 Tesla scanner prior to and 1 to 7 days after catheter ablation

Primary outcome measure

  • Incident of overt and covert CNS injury 7 days post AF ablation [ Time Frame: 7 days post AF ablation ]
  • Incident of overt and covert CNS injury 90 days post AF ablation [ Time Frame: 90 days post AF ablation ]

Central Contacts and Locations

Central contacts

Joseph Abdel Messih

507-422-3967mansour.joseph@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Grace Purkey

(507) 255-0774Purkey.Grace@mayo.edu

Principal Investigator:

Malini Madhavan, MBBS

More Information

Sponsor

Malini Madhavan

Last update posted

Jul 21, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Malini Madhavan on 2026-07-21.