Ev-AIFIB Preliminary Evaluation of the AIFib Software

Hospital St. Joseph, Marseille, France300 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Software Performance Evaluation a Posteriori

Interventions

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

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

Groupe Hopitaux Institut Catholique de Lille

Lille, France

Clinique de l'Infirmerie Protestante

Lyon, France

Saint Joseph Hospital

Marseille, France

Clinique Ambroise Paré, Neuilly

Neuilly-sur-Seine, France

Outcomes

Primary Outcomes

Software performance evaluation a posteriori

real-time validation by the second operator of the correct detection of atrial fibrillation driver

Time frame: during the ablation procedure

Secondary Outcomes

Indirect evaluation of the clinical effectiveness of the software

AF stopping rate by removal of the areas detected by the main operator and the software

Time frame: during the ablation procedure

Data from ClinicalTrials.gov

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