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Recruiting NCT04685317

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

No phase Interventional Arrhythmia Atrial Fibrillation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sentinel® Cerebral Protection System, Magnetic Resonance Imaging.
Who it may be relevant to
Registry conditions: Arrhythmia, Atrial Fibrillation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Pilot Randomized Study of the Use of The Sentinel Device for Cerebral Protection During Atrial Fibrillation Ablation

Overview

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.

Detailed description

If assigned to receive the device, the Sentinel® Cerebral Protection System will be placed in your heart at the beginning of your ablation procedure, and then removed along with any collected blood debris upon completion of your procedure. The study team will then call you 30 days after your procedure to assess any neurological events. Your final visit will be 90 days after your procedure to complete a second 30 minute session of cognitive testing.

Interventions

  • Device Sentinel® Cerebral Protection System
    A percutaneously delivered dual-filter protection device, designed to capture and remove debris dislodged during transcatheter aortic valve replacement procedures.
  • Diagnostic test 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 measures

  • 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]
Secondary outcome measures (2)
  • Change in neurocognitive function score [Time frame: Baseline, 90 days]
  • New cerebral infarcts [Time frame: day 1 to 7 after atrial fibrillation ablation]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT04685317 · 19-002836

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗