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NCT04685317 · ClinicalTrials.gov registry record · NA

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

A NA study of Atrial Fibrillation and Arrhythmia, sponsored by Malini Madhavan.

Recruiting
Registry status
NA
Development phase
48
Enrollment target
1
Study location

NCT04685317 is a NA study of Atrial Fibrillation and Arrhythmia that is actively recruiting participants, run by Malini Madhavan. The registered enrollment target is 48 participants, below the 2,997-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04685317, a NA study of Atrial Fibrillation and Arrhythmia, is actively recruiting participants, sponsored by Malini Madhavan.

RECRUITING
Registry status
NA
Development phase
48 participants
Enrollment target
1
Study location

Study 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.

Interventions

  • DIAGNOSTIC_TEST Magnetic Resonance Imaging
  • DEVICE Sentinel® Cerebral Protection System

Study Locations (1)

Minnesota

  • Mayo Clinic in Rochester - Rochester

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2023-03-07
Est. Completion 2026-12
Phase NA

Sponsor

Malini Madhavan

1 total trials

What the Registry Record Tells You About NCT04685317

The ClinicalTrials.gov registry entry for NCT04685317 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,997-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (98% lower). The listed sponsor is Malini Madhavan, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Atrial Fibrillation appearing as the primary indexed condition, and to 2 interventions - of which Magnetic Resonance Imaging is the first listed.

NCT04685317 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.

Frequently Asked Questions

What is clinical trial NCT04685317 about?

NCT04685317 is a clinical study titled "Safety and Efficacy of the Sentinel Cerebral Protection Device in Atrial Fibrillation Ablation". 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 Se...

What is the current status of trial NCT04685317?

This trial is currently recruiting. It is a NA study. The enrollment target is 48 participants. The study started on 2023-03-07. Estimated completion is 2026-12.

What conditions does trial NCT04685317 study?

This clinical trial studies the following conditions: Atrial Fibrillation, Arrhythmia.

What interventions are being tested in trial NCT04685317?

The interventions under investigation include: Magnetic Resonance Imaging (DIAGNOSTIC_TEST), Sentinel® Cerebral Protection System (DEVICE).

Who is sponsoring clinical trial NCT04685317?

This trial is sponsored by Malini Madhavan, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04685317 being conducted?

This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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