Ev-AIFIB Preliminary Evaluation of the AIFib Software
Completed
- Conditions
- Software Performance Evaluation a Posteriori
- Registration Number
- NCT03434964
- Lead Sponsor
- Hospital St. Joseph, Marseille, France
- Brief Summary
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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Software performance evaluation a posteriori during the ablation procedure real-time validation by the second operator of the correct detection of atrial fibrillation driver
- Secondary Outcome Measures
Name Time Method Indirect evaluation of the clinical effectiveness of the software during the ablation procedure AF stopping rate by removal of the areas detected by the main operator and the software
Trial Locations
- 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
CHU NICE Pasteur
🇫🇷Nice, France
Centre de cardiologie du Nord
🇫🇷Saint-Denis, France
Clinique Pasteur
🇫🇷Toulouse, France
IHCPS Massy
🇫🇷Paris, France