Ev-AIFIB Preliminary Evaluation of the AIFib Software

Software Performance Evaluation a Posteriori Clinical Trial

Official title:

Preliminary Evaluation of the AIFib Software in Real Time as a Medical Decision Aid for the Detection of Atrial Fibrillation Driver

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03434964
• Other study ID #: HSJ_EvAIFIB_2018
• Status: Completed
• Start date: July 17, 2018
• Est. completion date: July 31, 2020

Study information

• Verified date: April 2020
• Source: Hospital St. Joseph, Marseille, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: July 31, 2020
• Est. primary completion date: January 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Software Performance Evaluation a Posteriori

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
France	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	IHCPS Massy	Paris
France	Centre de cardiologie du Nord	Saint-Denis
France	Clinique Pasteur	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Hospital St. Joseph, Marseille, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Software performance evaluation a posteriori	real-time validation by the second operator of the correct detection of atrial fibrillation driver	during the ablation procedure
Secondary	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	during the ablation procedure