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NCT04964440 · ClinicalTrials.gov registry record

Redo AF Sub Study (of the Pure EP 2.0 Main Study)

A clinical trial of Atrial Fibrillation Recurrent, sponsored by BioSig Technologies.

Completed
Registry status
20
Enrollment target
1
Study location

NCT04964440: Completed study of Atrial Fibrillation Recurrent, sponsored by BioSig Technologies.

NCT04964440 is a study of Atrial Fibrillation Recurrent that has completed, run by BioSig Technologies. The registered enrollment target is 20 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04964440, a study of Atrial Fibrillation Recurrent, has completed, sponsored by BioSig Technologies.

COMPLETED
Registry status
20 participants
Enrollment target
1
Study location

Study Summary

This study is a sub study of the Pure EP 2.0 trial. In a redo atrial fibrillation population, this study is designed to collect pulmonary vein signals pre and post ablation therapy, along with other non-pulmonary vein signals of interest during a redo ablation procedure. These signals are later evaluated for clinical relevance and impact on the procedure.

Primary Outcome

The signals of interest will undergo a homogenization process to remove all identifiers of the system used. At a later time, a blinded electrophysiologist reviewer will evaluate the signals for clinical relevance and procedural impact from both systems using the same Blinded Signal Assessment Form. The Blinded Assessment Form results will be compared to both each other and what was done at the procedure.

Interventions

  • DEVICE Pure-EP

Study Locations (1)

Texas

  • St. David's Medical Center - Austin

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2021-03-03
Est. Completion 2022-01-29
BioSig Technologies

2 total trials

What the finished NCT04964440 record still lists

NCT04964440 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target.

The record links to 1 condition, with Atrial Fibrillation Recurrent appearing as the primary indexed condition, and to 1 intervention - of which Pure-EP is the first listed.

NCT04964440 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT04964440 about?

NCT04964440 is a clinical study titled "Redo AF Sub Study (of the Pure EP 2.0 Main Study)". This study is a sub study of the Pure EP 2.0 trial. In a redo atrial fibrillation population, this study is designed to collect pulmonary vein signals pre and post ablation therapy, along with other non-pulmonary vein signals of interest during a redo ablation procedure. These signals are later eval...

What is the current status of trial NCT04964440?

This trial is currently completed. The enrollment target is 20 participants. The study started on 2021-03-03. Estimated completion is 2022-01-29.

What conditions does trial NCT04964440 study?

This clinical trial studies the following conditions: Atrial Fibrillation Recurrent.

What interventions are being tested in trial NCT04964440?

The interventions under investigation include: Pure-EP (DEVICE).

Who is sponsoring clinical trial NCT04964440?

This trial is sponsored by BioSig Technologies, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04964440 being conducted?

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

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Source: ClinicalTrials.gov NCT04964440, the US trial registry maintained by the National Library of Medicine. NCT04964440 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.