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

NCT04683692 | Withdrawn FDA Device

• 1 other identifier: 20-001308
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (5)

• 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

  day 1 to 7 after atrial fibrillation ablation

• Change in high sensitivity CRP (hs-CRP)

  High sensitivity CRP (hs-CRP) measured in mg/L to detect changes in peripheral markers of inflammation

  baseline 1 - 30 days prior to ablation, days 1 - 7 after atrial fibrillation ablation

• Change in interleukin-6 (IL-6)

  Interleukin-6 measured in pg/ml to detect changes in peripheral markers of inflammation

  baseline 1 - 30 days prior to ablation, days 1 - 7 after atrial fibrillation ablation

• Change in NT-proBNP

  NT-proBNP measured in pg/ml to detect changes in tissue damage

  baseline 1 - 30 days prior to ablation, days 1 - 7 after atrial fibrillation ablation

• Change in high sensitivity troponin

  High sensitivity troponin measure in ng/mL to detect changes in tissue damage

  baseline 1 - 30 days prior to ablation, days 1 - 7 after atrial fibrillation ablation

Study Arms (2)

Cerebral protection with the Sentinel device

EXPERIMENTAL

Subjects who received the Sentinel device in the parent study

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

Control group without cerebral protection

ACTIVE COMPARATOR

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

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

Interventions

Magnetic Resonance Imaging (MRI) DEVICE

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

Cerebral protection with the Sentinel device; Control group without cerebral protection

Laboratory Testing 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

Cerebral protection with the Sentinel device; Control group without cerebral protection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Ammar Killu, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: For both the parent study and the sub-study, participants and investigators will be unblinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: September 25, 2020
• First Posted: December 24, 2020
• Study Start: March 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 14, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)