Clinical trial NCT03919097: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Flutter
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2019-04-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated at the CHU Brugmann Hospital for flutter ablation by radiofrequency between 1996 and 2018.

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.


Eligibility criteria: Inclusion Criteria:

Patients treated at the CHU Brugmann Hospital for flutter ablation by radiofrequency between 1996 and 2018.

Exclusion Criteria:

None

Primary outcomes:
measure: Age at ablation
timeFrame: One day
measure: Gender
timeFrame: One day
measure: Antecedents of ischemic cardiomyopathy
timeFrame: One day
measure: Antecedents of cardiomyopathy
timeFrame: One day
measure: Antecedents of dilated cardiomyopathy
timeFrame: One day
measure: Diabetes
timeFrame: One day
measure: Chronic pulmonal disease
timeFrame: One day
measure: Cardiac surgery antecedents
timeFrame: One day
measure: Atrial fibrillation antecedents
timeFrame: One day
measure: Beta-blockers post-ablation
timeFrame: One day
measure: Amiodarone post-ablation
timeFrame: One year
measure: Class I antiarrhythmic drugs post-ablation
timeFrame: One year
measure: Arterial hypertension
timeFrame: One day
measure: Antecedents of stroke
timeFrame: One day
measure: Stroke after flutter ablation
timeFrame: One year
measure: Antecedents of peripheric thromboembolic events
timeFrame: One day
measure: Peripheric thromboembolic events after flutter ablation
timeFrame: One year
measure: Atrial Fibrillation apparition delay
timeFrame: Up to one year
measure: Left ventricular ejection fraction of the heart
timeFrame: One day
measure: Left atrium size of the heart
timeFrame: One day
measure: Pulmonary arterial pressure
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
affiliation: CHU Brugmann
name: Georges Fayad, MD
role: PRINCIPAL_INVESTIGATOR
References: