FlutterNCT03919097
Identification of Risk Factors for Atrial Fibrillation After Ablation of an Atrial Flutter by Radiofrequency of the Cavotricuspid Isthmus.
An observational study of Flutter, run by José Castro at 1 site in Belgium.
Trial summary
Atrial flutter is a common condition that is effectively treated by ablation using radiofrequency. Due to its feasibility, effectiveness and low procedural risk, radiofrequency ablation is a first-line treatment of atrial flutter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Flutter
- What is being tested?
- Medical Data extraction
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Jan 2019to 20 Nov 2019
- 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 treated at the CHU Brugmann Hospital for flutter ablation by radiofrequency between 1996 and 2018.
Who may be able to join
- Patients treated at the CHU Brugmann Hospital for flutter ablation by radiofrequency between 1996 and 2018.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Study to Identify Risk Factors for Atrial Fibrillation After Ablation of Atrial Flutter by Radiofrequency of the Cavotricuspid Isthmus.
Atrial flutter is a common condition that is effectively treated by ablation using radiofrequency. Due to its feasibility, effectiveness and low procedural risk, radiofrequency ablation is a first-line treatment of atrial flutter.
Several studies have been published concerning the factors associated with the occurrence of atrial fibrillation during or after flutter ablation, in patients with and without clinical history of atrial fibrillation. 26 to 46% of patients are likely to develop it, according to ECG or Holter diagnoses. The figure rises to more than 50% with a diagnosis with an implantable loop recorder.
Read more
In patients without a prior history of atrial fibrillation before ablation, anticoagulants are routinely administered 4-6 weeks after flutter removal by most cardiologists.
Although there are no specific guidelines for anticoagulation after flutter ablation, it is currently recommended to treat the patient as for atrial fibrillation. It is therefore crucial to identify in advance patients at high risk of atrial fibrillation after flutter ablation, in order to assess the appropriateness of maintaining oral anticoagulant therapy.
The objectives of this study are:
- to evaluate the frequency and identify the factors predicting the occurrence of atrial fibrillation after flutter ablation
- to determine the risk of a stroke occurring in patients with atrial fibrillation after flutter ablation.
The database consists in patients of the CHU Brugmann Hospital treated between 1996 and 2018.
- Conditions
- Flutter
- Being tested
- Medical Data extraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Data extractionOther
Data extraction from the patient's Medical Files
| Study group | Role | What they receive |
|---|---|---|
| Control | No atrial arrhythmia post-ablation of a flutter by radiofrequency of the isthmus of the cavotricuspid valva. Receives: Other: Medical Data extraction | |
| Atrial fibrillation post ablation | Atrial arrhythmia (Atrial Fibrillation) post-ablation of a flutter by radiofrequency of the isthmus of the cavotricuspid valva. Receives: Other: Medical Data extraction | |
| Flutter recidive | Recidive of the flutter after ablation. Receives: Other: Medical Data extraction | |
| Atrial Fibrillation antecedents | Patients with atrial fibrillation after flutter ablation, with previous antecedents of atrial fibrillation. Receives: Other: Medical Data extraction | |
| No Atrial Fibrillation antecedents | Patients with atrial fibrillation after flutter ablation, without antecedents of atrial fibrillation. Receives: Other: Medical Data extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age at ablation
Age of the patient at the date of the flutter ablation
Measured: One day
Gender
Gender of the patient at the date of the flutter ablation
Measured: One day
Antecedents of ischemic cardiomyopathy
Antecedents of ischemic cardiomyopathy (yes/no) at the date of flutter ablation
Measured: One day
Antecedents of cardiomyopathy
Antecedents of cardiomyopathy (yes/no) at the date of flutter ablation
Measured: One day
Antecedents of dilated cardiomyopathy
Antecedents of dilated cardiomyopathy (yes/no) at the date of flutter ablation
Measured: One day
Diabetes
Diabetes diagnosis (yes/no) at the date of flutter ablation
Measured: One day
Chronic pulmonal disease
Chronic pulmonal disease diagnosed at the date of flutter ablation
Measured: One day
Cardiac surgery antecedents
Presence of cardiac surgery antecedents at the date of flutter ablation
Measured: One day
Atrial fibrillation antecedents
Antecedents of Atrial fibrillation at the date of flutter ablation
Measured: One day
Beta-blockers post-ablation
Prescription of Beta-Blockers after the flutter ablation (yes/no)
Measured: One day
Amiodarone post-ablation
Prescription of amiodarone after the flutter ablation (yes/no)
Measured: One year
Class I antiarrhythmic drugs post-ablation
Prescription of Class I antiarrhythmic drugs post-ablation
Measured: One year
Arterial hypertension
Presence of arterial hypertension on the day of flutter ablation
Measured: One day
Antecedents of stroke
Antecedents of stroke
Measured: One day
Stroke after flutter ablation
Occurence of stroke after the flutter ablation
Measured: One year
Antecedents of peripheric thromboembolic events
Antecedents of thromboembolic events on the day of flutter ablation
Measured: One day
Peripheric thromboembolic events after flutter ablation
Thromboembolic events after flutter ablation
Measured: One year
Atrial Fibrillation apparition delay
Delay of apparition of atrial fibrillation after flutter removal
Measured: Up to one year
Left ventricular ejection fraction of the heart
Left ventricular ejection fraction of the heart at the day of flutter removal (echographic data)
Measured: One day
Left atrium size of the heart
Left atrium size of the heart at the day of flutter removal (echographic data)
Measured: One day
Pulmonary arterial pressure
Pulmonary arterial pressure at the day of flutter removal (echographic data)
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start8 Jan 2019
- Primary completion20 Nov 2019
- Study completion20 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FlutterStudies 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
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- José Castro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, José Castro, Brugmann University Hospital
- Investigators
- Georges Fayad, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03919097
- Sponsor's protocol ID
- CHUB-Fayad
- Status last verified
- Jul 2022
- First submitted
- 15 Apr 2019
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study to Identify Risk Factors for Atrial Fibrillation After Ablation of Atrial Flutter by Radiofrequency of the Cavotricuspid Isthmus.
- ClinicalTrials.gov ID
- NCT03919097
- Acronym / sponsor ID
- CHUB-Fayad
- Conditions
- Flutter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- José CastroUniversity, hospital or other
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 20 Nov 2019 (actual)
- Study completion
- 20 Nov 2019 (actual)
- First posted
- 18 Apr 2019 (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.
Atrial flutter is a common condition that is effectively treated by ablation using radiofrequency. Due to its feasibility, effectiveness and low procedural risk, radiofrequency ablation is a first-line treatment of atrial flutter.
Several studies have been published concerning the factors associated with the occurrence of atrial fibrillation during or after flutter ablation, in patients with and without clinical history of atrial fibrillation. 26 to 46% of patients are likely to develop it, according to ECG or Holter diagnoses. The figure rises to more than 50% with a diagnosis with an implantable loop recorder.
In patients without a prior history of atrial fibrillation before ablation, anticoagulants are routinely administered 4-6 weeks after flutter removal by most cardiologists.
Although there are no specific guidelines for anticoagulation after flutter ablation, it is currently recommended to treat the patient as for atrial fibrillation. It is therefore crucial to identify in advance patients at high risk of atrial fibrillation after flutter ablation, in order to assess the appropriateness of maintaining oral anticoagulant therapy.
The objectives of this study are:
- to evaluate the frequency and identify the factors predicting the occurrence of atrial fibrillation after flutter ablation
- to determine the risk of a stroke occurring in patients with atrial fibrillation after flutter ablation.
The database consists in patients of the CHU Brugmann Hospital treated between 1996 and 2018.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control | – | Other: Medical Data extractionNo atrial arrhythmia post-ablation of a flutter by radiofrequency of the isthmus of the cavotricuspid valva. |
| Atrial fibrillation post ablation | – | Other: Medical Data extractionAtrial arrhythmia (Atrial Fibrillation) post-ablation of a flutter by radiofrequency of the isthmus of the cavotricuspid valva. |
| Flutter recidive | – | Other: Medical Data extractionRecidive of the flutter after ablation. |
| Atrial Fibrillation antecedents | – | Other: Medical Data extractionPatients with atrial fibrillation after flutter ablation, with previous antecedents of atrial fibrillation. |
| No Atrial Fibrillation antecedents | – | Other: Medical Data extractionPatients with atrial fibrillation after flutter ablation, without antecedents of atrial fibrillation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated at the CHU Brugmann Hospital for flutter ablation by radiofrequency between 1996 and 2018.
Key inclusion criteria (1 listed)
- Patients treated at the CHU Brugmann Hospital for flutter ablation by radiofrequency between 1996 and 2018.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Medical Data extractionData extraction from the patient's Medical Files | Other | Atrial Fibrillation antecedents, Atrial fibrillation post ablation, Control, Flutter recidive, No Atrial Fibrillation antecedents |
Primary outcome
Age at ablation
Time frame: One day
Age of the patient at the date of the flutter ablation
Gender
Time frame: One day
Gender of the patient at the date of the flutter ablation
Antecedents of ischemic cardiomyopathy
Time frame: One day
Antecedents of ischemic cardiomyopathy (yes/no) at the date of flutter ablation
Antecedents of cardiomyopathy
Time frame: One day
Antecedents of cardiomyopathy (yes/no) at the date of flutter ablation
Antecedents of dilated cardiomyopathy
Time frame: One day
Antecedents of dilated cardiomyopathy (yes/no) at the date of flutter ablation
Diabetes
Time frame: One day
Diabetes diagnosis (yes/no) at the date of flutter ablation
Chronic pulmonal disease
Time frame: One day
Chronic pulmonal disease diagnosed at the date of flutter ablation
Cardiac surgery antecedents
Time frame: One day
Presence of cardiac surgery antecedents at the date of flutter ablation
Atrial fibrillation antecedents
Time frame: One day
Antecedents of Atrial fibrillation at the date of flutter ablation
Beta-blockers post-ablation
Time frame: One day
Prescription of Beta-Blockers after the flutter ablation (yes/no)
Amiodarone post-ablation
Time frame: One year
Prescription of amiodarone after the flutter ablation (yes/no)
Class I antiarrhythmic drugs post-ablation
Time frame: One year
Prescription of Class I antiarrhythmic drugs post-ablation
Arterial hypertension
Time frame: One day
Presence of arterial hypertension on the day of flutter ablation
Antecedents of stroke
Time frame: One day
Antecedents of stroke
Stroke after flutter ablation
Time frame: One year
Occurence of stroke after the flutter ablation
Antecedents of peripheric thromboembolic events
Time frame: One day
Antecedents of thromboembolic events on the day of flutter ablation
Peripheric thromboembolic events after flutter ablation
Time frame: One year
Thromboembolic events after flutter ablation
Atrial Fibrillation apparition delay
Time frame: Up to one year
Delay of apparition of atrial fibrillation after flutter removal
Left ventricular ejection fraction of the heart
Time frame: One day
Left ventricular ejection fraction of the heart at the day of flutter removal (echographic data)
Left atrium size of the heart
Time frame: One day
Left atrium size of the heart at the day of flutter removal (echographic data)
Pulmonary arterial pressure
Time frame: One day
Pulmonary arterial pressure at the day of flutter removal (echographic data)
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 19 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Georges Fayad, MD principal investigator
CHU Brugmann
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 Flutter, run by José Castro at 1 site in Belgium.
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: finished, as of the sponsor's last update on 19 Jul 2022. 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 Belgium. 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?
Age at ablation (time frame: One day). The study lists 21 primary outcomes in all. 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 19 Jul 2022.