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Ev-AIFIB Preliminary Evaluation of the AIFib Software

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03434964
Recruitment Status : Active, not recruiting
First Posted : February 15, 2018
Last Update Posted : April 29, 2020
Sponsor:
Information provided by (Responsible Party):
Hospital St. Joseph, Marseille, France

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.

Condition or disease Intervention/treatment
Software Performance Evaluation a Posteriori Diagnostic Test: the intraoperative effectiveness of the AIFIB software in real time in the detection of atrial fibrillation drivers during an ablation procedure.

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Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Preliminary Evaluation of the AIFib Software in Real Time as a Medical Decision Aid for the Detection of Atrial Fibrillation Driver
Actual Study Start Date : July 17, 2018
Actual Primary Completion Date : January 13, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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


Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients ≥ 18 years with an indication of ablation of FA or TA
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03434964


Locations
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France
Groupe Hopitaux Institut Catholique de Lille
Lille, France
Clinique de l'Infirmerie Protestante
Lyon, France
Saint Joseph Hospital
Marseille, France, 13008
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
Sponsors and Collaborators
Hospital St. Joseph, Marseille, France
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Responsible Party: Hospital St. Joseph, Marseille, France
ClinicalTrials.gov Identifier: NCT03434964    
Other Study ID Numbers: HSJ_EvAIFIB_2018
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No