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出境医 / 临床实验 / Identification of Risk Factors for Atrial Fibrillation After Ablation of an Atrial Flutter by Radiofrequency of the Cavotricuspid Isthmus.
Identification of Risk Factors for Atrial Fibrillation After Ablation of an Atrial Flutter by Radiofrequency of the Cavotricuspid Isthmus.
Study Description
Brief 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.
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Flutter | Other: Medical Data extraction |
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 987 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Retrospective Study to Identify Risk Factors for Atrial Fibrillation After Ablation of Atrial Flutter by Radiofrequency of the Cavotricuspid Isthmus. |
| Actual Study Start Date : | January 8, 2019 |
| Estimated Primary Completion Date : | December 2019 |
| Estimated Study Completion Date : | December 2019 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
Control
No atrial arrhythmia post-ablation of a flutter by radiofrequency of the isthmus of the cavotricuspid valva.
|
Other: Medical Data extraction
Data extraction from the patient's Medical Files
|
|
Atrial fibrillation post ablation
Atrial arrhythmia (Atrial Fibrillation) post-ablation of a flutter by radiofrequency of the isthmus of the cavotricuspid valva.
|
Other: Medical Data extraction
Data extraction from the patient's Medical Files
|
|
Flutter recidive
Recidive of the flutter after ablation.
|
Other: Medical Data extraction
Data extraction from the patient's Medical Files
|
|
Atrial Fibrillation antecedents
Patients with atrial fibrillation after flutter ablation, with previous antecedents of atrial fibrillation.
|
Other: Medical Data extraction
Data extraction from the patient's Medical Files
|
|
No Atrial Fibrillation antecedents
Patients with atrial fibrillation after flutter ablation, without antecedents of atrial fibrillation.
|
Other: Medical Data extraction
Data extraction from the patient's Medical Files
|
Outcome Measures
Primary Outcome Measures :
- 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)
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients treated at the CHU Brugmann Hospital for flutter ablation by radiofrequency between 1996 and 2018.
Criteria
Inclusion Criteria:
Patients treated at the CHU Brugmann Hospital for flutter ablation by radiofrequency between 1996 and 2018.
Exclusion Criteria:
None
Contacts and Locations
Contacts
| Contact: Georges Fayad, MD | 3224772679 | Georges.FAYAD@chu-brugmann.be |
Locations
| Belgium | |
| CHU Brugmann | Recruiting |
| Brussels, Belgium, 1020 | |
| Contact: Georges Fayad, MD Georges.FAYAD@chu-brugmann.be | |
| Principal Investigator: Gerges Fayad | |
Sponsors and Collaborators
José Castro
Investigators
| Principal Investigator: | Georges Fayad, MD | CHU Brugmann |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | April 15, 2019 | ||||
| First Posted Date | April 18, 2019 | ||||
| Last Update Posted Date | April 18, 2019 | ||||
| Actual Study Start Date | January 8, 2019 | ||||
| Estimated Primary Completion Date | December 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
|
||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Identification of Risk Factors for Atrial Fibrillation After Ablation of an Atrial Flutter by Radiofrequency of the Cavotricuspid Isthmus. | ||||
| Official Title | Retrospective Study to Identify Risk Factors for Atrial Fibrillation After Ablation of Atrial Flutter by Radiofrequency of the Cavotricuspid Isthmus. | ||||
| Brief 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. 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:
The database consists in patients of the CHU Brugmann Hospital treated between 1996 and 2018. |
||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients treated at the CHU Brugmann Hospital for flutter ablation by radiofrequency between 1996 and 2018. | ||||
| Condition | Flutter | ||||
| Intervention | Other: Medical Data extraction
Data extraction from the patient's Medical Files
|
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| Study Groups/Cohorts |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Unknown status | ||||
| Estimated Enrollment |
987 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | December 2019 | ||||
| Estimated Primary Completion Date | December 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria: Patients treated at the CHU Brugmann Hospital for flutter ablation by radiofrequency between 1996 and 2018. Exclusion Criteria: None |
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| Sex/Gender |
|
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Belgium | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03919097 | ||||
| Other Study ID Numbers | CHUB-Fayad | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement |
|
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| Responsible Party | José Castro, Brugmann University Hospital | ||||
| Study Sponsor | José Castro | ||||
| Collaborators | Not Provided | ||||
| Investigators |
|
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| PRS Account | Brugmann University Hospital | ||||
| Verification Date | April 2019 | ||||
