Skip to main content
OpenTrials
Completed

NCT Number: NCT03434964

Ev-AIFIB Preliminary Evaluation of the AIFib Software

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Software Performance Evaluation a Posteriori

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe Hopitaux Institut Catholique de Lille, Lille, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Software performance evaluation a posteriori

    Time frame: during the ablation procedure

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

Secondary outcomes

  1. Indirect evaluation of the clinical effectiveness of the software

    Time frame: during the ablation procedure

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

Sponsors and collaborators

Lead sponsor

Hospital St. Joseph, Marseille, France

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 15, 2018
Registry last updated
Jun 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.