- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03401931
Artificial Intelligence Use for the Detection of Atrial Fibrillation Drivers (AI Fib)
April 24, 2020 updated by: SEITZ JULIEN, Hospital St. Joseph, Marseille, France
pilot clinical study, multicenter, prospective, open, nonrandomized
Study Overview
Status
Withdrawn
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 Type
Observational
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
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Aix-en-Provence, France, 13100
- Hopital d'Aix en Provence
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Nice, France, 06000
- CHU Nice
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Netherland
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Zwolle, Netherland, Netherlands
- Isala Hospital
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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
Non-Probability Sample
Study Population
major patient with an indication of AF or AT ablation
Description
Inclusion Criteria: major patient with an indication of AF or AT ablation -
Exclusion Criteria:
-
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 |
|---|---|---|
|
AF termination
Time Frame: during the ablation procedure
|
conversion to sinus rhythm or stable atrial tachycardia
|
during the ablation procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
AT termination
Time Frame: during the ablation procedure
|
conversion to sinus rhythm
|
during the ablation procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Julien SEITZ, MD, Hopital Saint Joseph
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)
January 9, 2018
Primary Completion (Actual)
January 9, 2018
Study Completion (Actual)
January 9, 2018
Study Registration Dates
First Submitted
January 9, 2018
First Submitted That Met QC Criteria
January 9, 2018
First Posted (Actual)
January 17, 2018
Study Record Updates
Last Update Posted (Actual)
April 28, 2020
Last Update Submitted That Met QC Criteria
April 24, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSJ_AIFIB_2017
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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