Software Performance Evaluation a PosterioriNCT03434964
Ev-AIFIB Preliminary Evaluation of the AIFib Software
An observational study of Software Performance Evaluation a Posteriori, run by Hospital St. Joseph, Marseille, France at 8 sites in France.
Trial summary
To evaluate the intraoperative effectiveness of the AIFIB software in real time in the detection of atrial fibrillation drivers during an ablation procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Software Performance Evaluation a Posteriori
- What is being tested?
- the intraoperative effectiveness of the AIFIB software in real time in the detection of atrial fibrillation drivers during an ablation procedure.
- How many people
- 300 participants
- Where
- 8 sitesFrance
- Study dates
- 17 Jul 2018to 31 Jul 2020
- 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: Patients ≥ 18 years with an indication of ablation of FA or TA
Who may be able to join
- 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.
Who cannot join
- Contraindication to AF ablation
- Major bleeding disorder
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Groupe Hopitaux Institut Catholique de Lille
Lille
Clinique de l'Infirmerie Protestante
Lyon
Saint Joseph Hospital
Marseille, 13008
Clinique Ambroise Paré, Neuilly
Neuilly-sur-Seine
CHU NICE Pasteur
Nice
IHCPS Massy
Paris
Centre de cardiologie du Nord
Saint-Denis
Clinique Pasteur
Toulouse
About this study
Official title: Preliminary Evaluation of the AIFib Software in Real Time as a Medical Decision Aid for the Detection of Atrial Fibrillation Driver
To evaluate the intraoperative effectiveness of the AIFIB software in real time in the detection of atrial fibrillation drivers during an ablation procedure.
- Being tested
- the intraoperative effectiveness of the AIFIB software in real time in the detection of atrial fibrillation drivers during an ablation procedure.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the intraoperative effectiveness of the AIFIB software in real time in the detection of atrial fibrillation drivers during an ablation procedure.Diagnostic test
Real-time validation by an expert operator of the correct detection of atrial fibrillation driver
What is being measured
The primary outcome is the main question the study is designed to answer.
Software performance evaluation a posteriori
real-time validation by the second operator of the correct detection of atrial fibrillation driver
Measured: during the ablation procedure
Secondary outcomes (1)
Indirect evaluation of the clinical effectiveness of the software
AF stopping rate by removal of the areas detected by the main operator and the software
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 posted15 Feb 2018
- Study start17 Jul 2018
- Primary completion13 Jan 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Software Performance Evaluation a PosterioriStudies 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital St. Joseph, Marseille, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03434964
- Sponsor's protocol ID
- HSJ_EvAIFIB_2018
- Status last verified
- Apr 2020
- First submitted
- 7 Feb 2018
- Last updated
- 23 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Evaluation of the AIFib Software in Real Time as a Medical Decision Aid for the Detection of Atrial Fibrillation Driver
- ClinicalTrials.gov ID
- NCT03434964
- Acronym / sponsor ID
- HSJ_EvAIFIB_2018
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Hospital St. Joseph, Marseille, FranceUniversity, hospital or other
- Study start
- 17 Jul 2018 (actual)
- Primary completion
- 13 Jan 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 15 Feb 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.
To evaluate the intraoperative effectiveness of the AIFIB software in real time in the detection of atrial fibrillation drivers during an ablation procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients ≥ 18 years with an indication of ablation of FA or TA
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Contraindication to AF ablation
- Major bleeding disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Diagnostic test | – |
Primary outcome
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
1 secondary outcome
Indirect evaluation of the clinical effectiveness of the software
Time frame: during the ablation procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Software Performance Evaluation a Posteriori, run by Hospital St. Joseph, Marseille, France at 8 sites in France.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Software performance evaluation a posteriori (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 23 Jun 2021.