A Study to Assess the Use of The Sentinel Device During Atrial Fibrillation Ablation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-31

Study Completion Date

2024-12-31

Brief Summary

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Researchers are determining whether the use of the Sentinel cerebral protection device during atrial fibrillation ablation will affect the occurrence of new cerebral infarcts in brain MRI. We are also studying if laboratory tests can be used to predict the rate of cerebral infarction and microbleeds in patients undergoing atrial fibrillation (AF) ablation procedures with and without use of the Sentinel Device.

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Detailed Description

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Patients currently participating in the research study titled: "A Pilot Randomized Study of the Use of the Sentinel Device for Cerebral Protection during Atrial Fibrillation Ablation" will be asked to participate in this sub-study to collect additional MRI and laboratory data to support the main study. This study will assess the number, size and volume of new cerebral emboli in protected territories detected using MRI of the brain within 7 days after AF ablation in patients treated with the Sentinel device compared to controls not receiving the Sentinel device, and to assess if change in blood inflammatory markers is associated with silent cerebral lesions.

Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parent Study Design: Patients undergoing clinically indicated catheter ablation for AF in the parent study will be randomized 2:1 to two arms: (1) cerebral protection with the Sentinel device and (2) control group without cerebral protection

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

For both the parent study and the sub-study, participants and investigators will be unblinded.

Study Groups

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Cerebral protection with the Sentinel device

Subjects who received the Sentinel device in the parent study

Group Type EXPERIMENTAL

Magnetic Resonance Imaging (MRI)

Intervention Type DEVICE

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

Laboratory Testing

Intervention Type OTHER

Laboratory blood testing to include high sensitivity CRP (hs-CRP), interleukin-6 (IL-6), NT-proBNP and high sensitivity troponin prior to and post-ablation

Control group without cerebral protection

Subjects who did not received the Sentinel device in the parent study

Group Type ACTIVE_COMPARATOR

Magnetic Resonance Imaging (MRI)

Intervention Type DEVICE

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

Laboratory Testing

Intervention Type OTHER

Laboratory blood testing to include high sensitivity CRP (hs-CRP), interleukin-6 (IL-6), NT-proBNP and high sensitivity troponin prior to and post-ablation

Interventions

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Magnetic Resonance Imaging (MRI)

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

Intervention Type DEVICE

Laboratory Testing

Laboratory blood testing to include high sensitivity CRP (hs-CRP), interleukin-6 (IL-6), NT-proBNP and high sensitivity troponin prior to and post-ablation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients over the age of 18 years undergoing radiofrequency or cryoballoon ablation for AF who provide informed consent will be included

Exclusion Criteria

* Severe peripheral arterial disease that precludes deployment of Sentinel device
* Unable to undergo MRI brain due to the presence of an MRI noncompatible implanted device
* Unable or unwilling to provide informed consent.
* Known history of dementia.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No