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Ev-AIFIB Preliminary Evaluation of the AIFib Software

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03434964
Enrollment
300
Registered
2018-02-15
Start date
2018-07-17
Completion date
2020-07-31
Last updated
2021-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Software Performance Evaluation a Posteriori

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.

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

Sponsors

Hospital St. Joseph, Marseille, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Software performance evaluation a posterioriduring the ablation procedurereal-time validation by the second operator of the correct detection of atrial fibrillation driver

Secondary

MeasureTime frameDescription
Indirect evaluation of the clinical effectiveness of the softwareduring the ablation procedureAF stopping rate by removal of the areas detected by the main operator and the software

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026