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Artificial Intelligence Use for the Detection of Atrial Fibrillation Drivers (AI Fib)

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: NCT03401931
Recruitment Status : Withdrawn (another design of protocole is submitted for approuval before the start date)
First Posted : January 17, 2018
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
SEITZ JULIEN, Hospital St. Joseph, Marseille, France

Study Description
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Brief Summary:
pilot clinical study, multicenter, prospective, open, nonrandomized

Condition or disease
Fibrillation, Atrial To Evaluate the Intraoperative Efficiency of the AIFIB Software in the Detection of Atrial Fibrillation Driver During an Ablation Procedure

Detailed Description:
The hypothesis is that ablation targeting PVI alone for the treatment of persistent AF is less efficient that ablation targeting electrophysiologic areas with spatio-temporal-dispersion with or without PVI
Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Artificial Intelligence Use for the Detection of Atrial Fibrillation Drivers
Actual Study Start Date : January 9, 2018
Actual Primary Completion Date : January 9, 2018
Actual Study Completion Date : January 9, 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. AF termination [ Time Frame: during the ablation procedure ]
    conversion to sinus rhythm or stable atrial tachycardia


Secondary Outcome Measures :
  1. AT termination [ Time Frame: during the ablation procedure ]
    conversion to sinus rhythm


Eligibility Criteria
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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:   Non-Probability Sample
Study Population
major patient with an indication of AF or AT ablation
Criteria

Inclusion Criteria: major patient with an indication of AF or AT ablation -

Exclusion Criteria:

-

Contacts and Locations
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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): NCT03401931


Locations
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France
Hopital d'Aix en Provence
Aix-en-Provence, France, 13100
CHU Nice
Nice, France, 06000
Netherlands
Isala Hospital
Zwolle, Netherland, Netherlands
Sponsors and Collaborators
Hospital St. Joseph, Marseille, France
Investigators
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Principal Investigator: Julien SEITZ, MD Hopital saint Joseph
More Information
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Additional Information:

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Responsible Party: SEITZ JULIEN, Cardiologist, Electrophysiology specialist, Hospital St. Joseph, Marseille, France
ClinicalTrials.gov Identifier: NCT03401931    
Other Study ID Numbers: HSJ_AIFIB_2017
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes