Safety and Efficacy of the Sentinel Cerebral Protection Device in Atrial Fibrillation Ablation
NCT ID: NCT04685317
Last Updated: 2025-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
48 participants
INTERVENTIONAL
2023-03-07
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Acute Cerebrovascular Events in Patients Undergoing Catheter Ablation
NCT05694273
Irrigated Ablation System Evaluation for Atrial Fibrillation (AF)
NCT01056328
Implanted Loop Recorder Post Atrial Fibrillation Ablation
NCT00915720
Cryoballoon vs. Rhythmia Guided Ablation for Recurrent AFib
NCT03811795
Assessing the Neurological Outcomes After Atrial Fibrillation Ablation for Rhythm Control
NCT06783868
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Sentinel® Cerebral Protection System Group
Sentinel® Cerebral Protection System in patients undergoing AF catheter ablation
Sentinel® Cerebral Protection System
A percutaneously delivered dual-filter protection device, designed to capture and remove debris dislodged during transcatheter aortic valve replacement procedures.
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
Standard of Care Group
Standard of care (no cerebral protection device) in patients undergoing AF catheter ablation
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sentinel® Cerebral Protection System
A percutaneously delivered dual-filter protection device, designed to capture and remove debris dislodged during transcatheter aortic valve replacement procedures.
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Malini Madhavan
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Malini Madhavan
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Malini Madhavan, MBBS
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Related Links
Access external resources that provide additional context or updates about the study.
Mayo Clinic Clinical Trials
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
19-002836
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.