Observation of Outcome After Catheter Ablation of Atrial FibrillationFrenchAFNCT01918670
A French Multi-centric Atrial Fibrillation Catheter Ablation Survey
An observational study of Observation of Outcome After Catheter Ablation of Atrial Fibrillation, run by Clinique Pasteur at 1 site in France.
Trial summary
Atrial fibrillation is the most frequent sustained arrhythmia. Catheter ablation is a procedure that is currently used for the treatment of symptomatic atrial fibrillation patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Observation of Outcome After Catheter Ablation of Atrial Fibrillation
- What is being tested?
- catheter ablation of atrial fibrillation
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteFrance
- Study dates
- Nov 2010to Dec 2013
- How long will I take part?
- 18 Months
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing catheter ablation in one of the registry centers
Who may be able to join
- all patients undergoing catheter ablation of atrial fibrillation or left atrial flutter
Who cannot join
- patients undergoing catheter ablation of other types of arrhythmia
Trial locations and contacts
1 site in 1 country.
About this study
Atrial fibrillation is the most frequent sustained arrhythmia. Catheter ablation is a procedure that is currently used for the treatment of symptomatic atrial fibrillation patients.
We have organized a multi-centric national survey of catheter ablation of atrial fibrillation in order to have a feedback on the type of procedures being performed and the overall results (freedom of atrial fibrillation) over an average follow-up of 18 months.
- Being tested
- catheter ablation of atrial fibrillation
- Keywords
- atrial fibrillation; catheter ablation; relapse; stroke; death
- Medical subject headings
- Atrial Fibrillation, Recurrence, Stroke, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
catheter ablation of atrial fibrillationProcedure or surgery
electric pulmonary vein disconnection
| Study group | Role | What they receive |
|---|---|---|
| Pasteur | Not described Receives: Procedure: catheter ablation of atrial fibrillation | |
| Grenoble | Not described Receives: Procedure: catheter ablation of atrial fibrillation | |
| Nantes | Not described Receives: Procedure: catheter ablation of atrial fibrillation | |
| Parly | Not described Receives: Procedure: catheter ablation of atrial fibrillation | |
| Rennes | Not described Receives: Procedure: catheter ablation of atrial fibrillation | |
| Rouen | Not described Receives: Procedure: catheter ablation of atrial fibrillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial fibrillation relapse
Documentation of atrial fibrillation relapse (symptomatic or asymptomatic) after the first 3 months after the index procedure
Measured: starting 3 months after the procedure till an average of 18months follow-up
Secondary outcomes (1)
Early atrial fibrillation relapse
Documented atrial fibrillation relapse (symptomatic or asymptomatic) in the first 3 months after the index procedure
Measured: first 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2013 (estimated)
- Study startNov 2010
- Primary completionJul 2013
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Observation of Outcome After Catheter Ablation of Atrial FibrillationStudies 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
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Clinique Pasteur
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Grenoble, Nouvelle Clinique Nantaise, Nantes, France, Hôpital Privé de Parly II - Le Chesnay, Rennes University Hospital, University Hospital, Rouen
- Responsible party
- Principal investigator, Serge Boveda, Clinique Pasteur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918670
- Sponsor's protocol ID
- FrenchAFAblationSurvey
- Acronym
- FrenchAF
- Status last verified
- Aug 2013
- First submitted
- 6 Aug 2013
- Last updated
- 8 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A French Multi-centric Atrial Fibrillation Catheter Ablation Survey
- ClinicalTrials.gov ID
- NCT01918670
- Acronym / sponsor ID
- FrenchAF / FrenchAFAblationSurvey
- Keywords
- atrial fibrillation; catheter ablation; relapse; stroke; death
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- Clinique PasteurUniversity, hospital or other
- Collaborators
- University Hospital, Grenoble, Nouvelle Clinique Nantaise, Nantes, France, Hôpital Privé de Parly II - Le Chesnay, Rennes University Hospital, University Hospital, Rouen
- Study start
- Nov 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Dec 2013 (estimated)
- First posted
- 8 Aug 2013 (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.
Atrial fibrillation is the most frequent sustained arrhythmia. Catheter ablation is a procedure that is currently used for the treatment of symptomatic atrial fibrillation patients.
We have organized a multi-centric national survey of catheter ablation of atrial fibrillation in order to have a feedback on the type of procedures being performed and the overall results (freedom of atrial fibrillation) over an average follow-up of 18 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Pasteur | – | Procedure: catheter ablation of atrial fibrillation |
| Grenoble | – | Procedure: catheter ablation of atrial fibrillation |
| Nantes | – | Procedure: catheter ablation of atrial fibrillation |
| Parly | – | Procedure: catheter ablation of atrial fibrillation |
| Rennes | – | Procedure: catheter ablation of atrial fibrillation |
| Rouen | – | Procedure: catheter ablation of atrial fibrillation |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing catheter ablation in one of the registry centers
Key inclusion criteria (1 listed)
- all patients undergoing catheter ablation of atrial fibrillation or left atrial flutter
Key exclusion criteria (1 listed)
- patients undergoing catheter ablation of other types of arrhythmia
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 |
|---|---|---|
| catheter ablation of atrial fibrillationelectric pulmonary vein disconnection | Procedure or surgery | Grenoble, Nantes, Parly, Pasteur, Rennes, Rouen |
Primary outcome
Atrial fibrillation relapse
Time frame: starting 3 months after the procedure till an average of 18months follow-up
Documentation of atrial fibrillation relapse (symptomatic or asymptomatic) after the first 3 months after the index procedure
1 secondary outcome
Early atrial fibrillation relapse
Time frame: first 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2013.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Observation of Outcome After Catheter Ablation of Atrial Fibrillation, run by Clinique Pasteur at 1 site 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 1 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: status not confirmed, as of the sponsor's last update on 8 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
Atrial fibrillation relapse (time frame: starting 3 months after the procedure till an average of 18months follow-up). 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 8 Aug 2013.