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

Mayo Clinic

Status: Withdrawn

Conditions: Atrial Fibrillation

Treatments: Device: Magnetic Resonance Imaging (MRI); Other: Laboratory Testing

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04683692

20-001308

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Cerebral protection with the Sentinel device

Experimental group

Description:

Subjects who received the Sentinel device in the parent study

Treatment:

Device: Magnetic Resonance Imaging (MRI)

Other: Laboratory Testing

Control group without cerebral protection

Active Comparator group

Description:

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

Treatment:

Device: Magnetic Resonance Imaging (MRI)

Other: Laboratory Testing