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

ConditionsArrhythmiaAtrial Fibrillation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMalini Madhavan

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sentinel® Cerebral Protection System

    Device

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

  • Magnetic Resonance Imaging

    Diagnostic test

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

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Sentinel® Cerebral Protection System GroupExperimental treatment 2 interventions
Group B: Standard of Care GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incident of overt and covert CNS injury 7 days post AF ablation

Incidence of overt and covert CNS injury confirmed using physical examination and / or brain imaging during or within 7 days of the AF ablation

Time frame
7 days post AF ablation
2

Incident of overt and covert CNS injury 90 days post AF ablation

Incidence of overt and covert CNS injury during or within 90 days of the AF ablation

Time frame
90 days post AF ablation

Secondary outcomes

1

Change in neurocognitive function score

Montreal cognitive assessment will administered at baseline and 90 days following ablation. Change in cognitive function score will be compared between the groups. The score ranges from 0 to 30 with higher score indicating better cognitive performance.

Time frame
Baseline, 90 days
2

New cerebral infarcts

Total number of new cerebral infarcts in the protected territories detected on brain MRI after ablation in the Sentinel device group vs control group

Time frame
day 1 to 7 after atrial fibrillation ablation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Malini Madhavan

Lead sponsor

Mayo Clinic

Sponsor institution

Source ClinicalTrials.gov
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