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RECRUITING NA

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

NCT04685317 · View on ClinicalTrials.gov ↗

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

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04685317

The ClinicalTrials.gov registry entry for NCT04685317 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Malini Madhavan, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04685317 reports 1 study location spanning 1 distinct geographic area — top geographies include Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04685317?

The interventions under investigation include: Magnetic Resonance Imaging (DIAGNOSTIC_TEST), Sentinel® Cerebral Protection System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04685317?

This trial is sponsored by Malini Madhavan, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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