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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: Recruiting NA study of Atrial Fibrillation and Arrhythmia, sponsored by Malini Madhavan.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Incidence of overt and covert CNS injury confirmed using physical examination and / or brain imaging during or within 7 days of the AF ablation
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Magnetic Resonance Imaging
- DEVICE Sentinel® Cerebral Protection System
Study Locations (1)
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2023-03-07 |
| Est. Completion | 2026-12 |
| Phase | NA |
What NCT04685317 shows while recruiting
NCT04685317 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 2,997-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (98% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT04685317's enrollment target sits among peer trials
48 179th of 202 higher than 24 of 202 other Atrial Fibrillation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atrial Fibrillation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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