Ev-AIFIB Preliminary Evaluation of the AIFib Software

June 22, 2021 updated by: Hospital St. Joseph, Marseille, France

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France
        • Groupe Hopitaux Institut Catholique de Lille
      • Lyon, France
        • Clinique de L'Infirmerie Protestante
      • Marseille, France, 13008
        • Saint Joseph Hospital
      • Neuilly-sur-Seine, France
        • Clinique Ambroise Paré, Neuilly
      • Nice, France
        • CHU NICE Pasteur
      • Paris, France
        • IHCPS Massy
      • Saint-Denis, France
        • Centre de cardiologie du Nord
      • Toulouse, France
        • Clinique Pasteur

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients ≥ 18 years with an indication of ablation of FA or TA

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
during the ablation procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
during the ablation procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital St. Joseph, Marseille, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2018

Primary Completion (Actual)

January 13, 2020

Study Completion (Actual)

July 31, 2020

Study Registration Dates

First Submitted

February 7, 2018

First Submitted That Met QC Criteria

February 14, 2018

First Posted (Actual)

February 15, 2018

Study Record Updates

Last Update Posted (Actual)

June 23, 2021

Last Update Submitted That Met QC Criteria

June 22, 2021

Last Verified

April 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • HSJ_EvAIFIB_2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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