RecruitingNot ApplicableNCT04685317

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

A Pilot Randomized Study of the Use of The Sentinel Device for Cerebral Protection During Atrial Fibrillation Ablation


Sponsor

Malini Madhavan

Enrollment

48 participants

Start Date

Mar 7, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a small device called the Sentinel, which is placed in the bloodstream during atrial fibrillation (AF) ablation procedures to catch any debris that might travel to the brain and cause a stroke. The aim is to see if this protection device reduces the risk of silent brain injury during the procedure. **You may be eligible if...** - You are 18 or older - You have atrial fibrillation (an irregular heartbeat) and are scheduled for a catheter ablation procedure (radiofrequency, pulsed field, or cryo-balloon) - You are having the procedure because medications have not worked or you cannot tolerate them - You are able to give informed consent **You may NOT be eligible if...** - Your anatomy (blood vessel size or shape) is not compatible with the Sentinel device - You have other conditions that make participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESentinel® Cerebral Protection System

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

DIAGNOSTIC_TESTMagnetic 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


Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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NCT04685317


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