Fibrillation, AtrialAI FibNCT03401931
Artificial Intelligence Use for the Detection of Atrial Fibrillation Drivers
An observational study of Fibrillation, Atrial and To Evaluate the Intraoperative Efficiency of the AIFIB Software in the Detection of Atrial Fibrillation Driver During an Ablation Procedure, run by Hospital St. Joseph, Marseille, France at 3 sites in 2 countries.
Trial summary
pilot clinical study, multicenter, prospective, open, nonrandomized Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibrillation, Atrial, To Evaluate the Intraoperative Efficiency of the AIFIB Software in the Detection of Atrial Fibrillation Driver During an Ablation Procedure
- How many people
- 0 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 9 Jan 2018to 9 Jan 2018
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: major patient with an indication of AF or AT ablation
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
France2 sites
Hopital d'Aix en Provence
Aix-en-Provence, 13100
CHU Nice
Nice, 06000
About this study
pilot clinical study, multicenter, prospective, open, nonrandomized
Read the 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
- Conditions
- Fibrillation, Atrial, To Evaluate the Intraoperative Efficiency of the AIFIB Software in the Detection of Atrial Fibrillation Driver During an Ablation Procedure
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
AF termination
conversion to sinus rhythm or stable atrial tachycardia
Measured: during the ablation procedure
Secondary outcomes (1)
AT termination
conversion to sinus rhythm
Measured: during the ablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start9 Jan 2018
- Primary completion9 Jan 2018
- Study completion9 Jan 2018
Why it stopped: another design of protocole is submitted for approuval before the start date
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibrillation, AtrialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Hospital St. Joseph, Marseille, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SEITZ JULIEN, Hospital St. Joseph, Marseille, France
- Investigators
- Julien SEITZ, MD, Principal investigator, Hopital saint Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03401931
- Sponsor's protocol ID
- HSJ_AIFIB_2017
- Acronym
- AI Fib
- Status last verified
- Apr 2020
- First submitted
- 9 Jan 2018
- Last updated
- 28 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence Use for the Detection of Atrial Fibrillation Drivers
- ClinicalTrials.gov ID
- NCT03401931
- Acronym / sponsor ID
- AI Fib / HSJ_AIFIB_2017
- Conditions
- Fibrillation, Atrial, To Evaluate the Intraoperative Efficiency of the AIFIB Software in the Detection of Atrial Fibrillation Driver During an Ablation Procedure
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: another design of protocole is submitted for approuval before the start date
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospital St. Joseph, Marseille, FranceUniversity, hospital or other
- Study start
- 9 Jan 2018 (actual)
- Primary completion
- 9 Jan 2018 (actual)
- Study completion
- 9 Jan 2018 (actual)
- First posted
- 17 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
pilot clinical study, multicenter, prospective, open, nonrandomized
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- major patient with an indication of AF or AT ablation
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
AF termination
Time frame: during the ablation procedure
conversion to sinus rhythm or stable atrial tachycardia
1 secondary outcome
AT termination
Time frame: during the ablation procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julien SEITZ, MD principal investigator
Hopital saint Joseph
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibrillation, Atrial and To Evaluate the Intraoperative Efficiency of the AIFIB Software in the Detection of Atrial Fibrillation Driver During an Ablation Procedure, run by Hospital St. Joseph, Marseille, France at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AF termination (time frame: during the ablation procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2020.