Atrial Fibrilation Termination EndpointNCT02099643
Crucial Areas on AF Termination
An observational study of Atrial Fibrilation Termination Endpoint, run by Hospital St. Joseph, Marseille, France at 4 sites in 2 countries.
Trial summary
Recent data has demonstrated that focal sources are determinant in human atrial fibrillation (AF) perpetuation. The investigators sought to identify crucial areas for AF perpetuation during our routine electrogram (EGM)-based substrate ablation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrilation Termination Endpoint
- How many people
- 113 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Dec 2008to Mar 2014
- How long will I take part?
- 5 Days
- 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 with symptomatic Atrial Fibrilation undergoing EGM-based substrate ablation were included.
Who may be able to join
- Atrial Fibrilation
- Undergoing EGM-based substrate ablation
Who cannot join
- Age < 18
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
France3 sites
Hopital Saint Joseph
Marseille, 13008
Hôpital Privé Jacques Cartier;
Massy
Institut Mutualiste Montsouris;
Paris
About this study
Official title: Crucial Areas on Atrial Fibrillation Termination by Substrate Ablation: Relevance to Anatomy
Recent data has demonstrated that focal sources are determinant in human atrial fibrillation (AF) perpetuation.
The investigators sought to identify crucial areas for AF perpetuation during our routine electrogram (EGM)-based substrate ablation.
- Conditions
- Atrial Fibrilation Termination Endpoint
What is being measured
The primary outcome is the main question the study is designed to answer.
Atria fibrillation termination during procedure
conversion to atrial tachycardia (AT) or sinus rhythm
Measured: 240 min
Secondary outcomes (1)
Crucial points
Crucial points were defined by areas where ablation immediately extended the cycle length> 20% of AF CL, or regularized Atrial Fibrilation (AF) into Atrial Tachycardia (AT) or converted AF (or AT) into Sinus Rythm
Measured: 240 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2014 (estimated)
- Study startDec 2008
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrilation Termination EndpointStudies 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
- 113 participants (actual)
- Target duration
- 5 Days
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02099643
- Sponsor's protocol ID
- HSJ-2013-03
- Status last verified
- Mar 2014
- First submitted
- 26 Mar 2014
- Last updated
- 31 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crucial Areas on Atrial Fibrillation Termination by Substrate Ablation: Relevance to Anatomy
- ClinicalTrials.gov ID
- NCT02099643
- Acronym / sponsor ID
- HSJ-2013-03
- Conditions
- Atrial Fibrilation Termination Endpoint
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Hospital St. Joseph, Marseille, FranceUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 31 Mar 2014 (estimated)
- 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.
Recent data has demonstrated that focal sources are determinant in human atrial fibrillation (AF) perpetuation.
The investigators sought to identify crucial areas for AF perpetuation during our routine electrogram (EGM)-based substrate ablation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with symptomatic Atrial Fibrilation undergoing EGM-based substrate ablation were included.
Key inclusion criteria (2 listed)
- Atrial Fibrilation
- Undergoing EGM-based substrate ablation
Key exclusion criteria (1 listed)
- Age < 18
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
Atria fibrillation termination during procedure
Time frame: 240 min
conversion to atrial tachycardia (AT) or sinus rhythm
1 secondary outcome
Crucial points
Time frame: 240 min
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 31 Mar 2014.
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.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrilation Termination Endpoint, run by Hospital St. Joseph, Marseille, France at 4 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 2 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: finished, as of the sponsor's last update on 31 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, United Kingdom. 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?
Atria fibrillation termination during procedure (time frame: 240 min). 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 31 Mar 2014.