Ev-AIFIB Preliminary Evaluation of the AIFib Software

NCT ID: NCT03434964

Last Updated: 2021-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-17

Study Completion Date

2020-07-31

Brief Summary

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To evaluate the intraoperative effectiveness of the AIFIB software in real time in the detection of atrial fibrillation drivers during an ablation procedure.

Detailed Description

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Conditions

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Software Performance Evaluation a Posteriori

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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the intraoperative effectiveness of the AIFIB software in real time in the detection of atrial fibrillation drivers during an ablation procedure.

Real-time validation by an expert operator of the correct detection of atrial fibrillation driver

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients 18 years of age or older
* Etiology in the following list:
* Atrial fibrillation for which a conventional anatomical approach alone (pulmonary vein isolation) is not performed: persistent AF, long standing persistent AF paroxysmal AF (redo), paroxysmal AF
* Atrial tachycardia de novo or secondary to AF ablation.

Exclusion Criteria

* Contraindication to AF ablation
* Major bleeding disorder
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital St. Joseph, Marseille, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Groupe Hopitaux Institut Catholique de Lille

Lille, , France

Site Status

Clinique de l'Infirmerie Protestante

Lyon, , France

Site Status

Saint Joseph Hospital

Marseille, , France

Site Status

Clinique Ambroise Paré, Neuilly

Neuilly-sur-Seine, , France

Site Status

CHU NICE Pasteur

Nice, , France

Site Status

IHCPS Massy

Paris, , France

Site Status

Centre de cardiologie du Nord

Saint-Denis, , France

Site Status

Clinique Pasteur

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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HSJ_EvAIFIB_2018

Identifier Type: -

Identifier Source: org_study_id

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