CHU Brugmann
Brussels, 1020, Belgium
Completed
NCT Number: NCT03919097
Identification of Risk Factors for Atrial Fibrillation After Ablation of an 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.
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients treated at the CHU Brugmann Hospital for flutter ablation by radiofrequency between 1996 and 2018.
Exclusion criteria
None
Treatment and study plan
Medical Data extraction
OtherData extraction from the patient's Medical Files
Primary outcomes
-
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)
Sponsors and collaborators
Lead sponsor
José Castro
Other
Registry information
Official study title
Retrospective Study to Identify Risk Factors for Atrial Fibrillation After Ablation of Atrial Flutter by Radiofrequency of the Cavotricuspid Isthmus.
Important dates
- Study start
- 2019
- Primary completion
- 2019
- Study completion
- 2019
- First posted
- Apr 18, 2019
- Registry last updated
- Jul 19, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.