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CompletedNCT03434964Updated Jun 23, 2021

Ev-AIFIB Preliminary Evaluation of the AIFib Software

An observational study in Software Performance Evaluation a Posteriori, sponsored by Hospital St. Joseph, Marseille, France. Completed at 8 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-23.

Sponsored by Hospital St. Joseph, Marseille, France · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Software Performance Evaluation a Posteriori
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

Exclusion Criteria:

  • Contraindication to AF ablation
  • Major bleeding disorder
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testthe 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

05

What researchers measure

Primary outcomes

  1. 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

  1. 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

06

Study locations

8 sites
  • Groupe Hopitaux Institut Catholique de Lille
    Lille, France
  • Clinique de l'Infirmerie Protestante
    Lyon, France
  • Saint Joseph Hospital
    Marseille, 13008, 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, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03434964
Lead sponsor
Hospital St. Joseph, Marseille, France
Responsible party
Sponsor
First posted
Feb 15, 2018
Start date
Jul 17, 2018
Primary completion
Jan 13, 2020
Completion
Jul 31, 2020
Last update
Jun 23, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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