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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for all trials

Timeline

Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

11 months study duration

Study Start

First participant enrolled

January 8, 2019

Completed

3 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2019

Completed

3 days until next milestone

First Posted

Study publicly available on registry

April 18, 2019

Completed

7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2019

Completed

Last Updated

July 19, 2022

Status Verified

July 1, 2022

Enrollment Period

11 months

First QC Date

April 15, 2019

Last Update Submit

July 18, 2022

Conditions

Flutter

Outcome Measures

Primary Outcomes (21)

Age at ablation
Age of the patient at the date of the flutter ablation
One day
Gender
Gender of the patient at the date of the flutter ablation
One day
Antecedents of ischemic cardiomyopathy
Antecedents of ischemic cardiomyopathy (yes/no) at the date of flutter ablation
One day
Antecedents of cardiomyopathy
Antecedents of cardiomyopathy (yes/no) at the date of flutter ablation
One day
Antecedents of dilated cardiomyopathy
Antecedents of dilated cardiomyopathy (yes/no) at the date of flutter ablation
One day
Diabetes
Diabetes diagnosis (yes/no) at the date of flutter ablation
One day
Chronic pulmonal disease
Chronic pulmonal disease diagnosed at the date of flutter ablation
One day
Cardiac surgery antecedents
Presence of cardiac surgery antecedents at the date of flutter ablation
One day
Atrial fibrillation antecedents
Antecedents of Atrial fibrillation at the date of flutter ablation
One day
Beta-blockers post-ablation
Prescription of Beta-Blockers after the flutter ablation (yes/no)
One day
Amiodarone post-ablation
Prescription of amiodarone after the flutter ablation (yes/no)
One year
Class I antiarrhythmic drugs post-ablation
Prescription of Class I antiarrhythmic drugs post-ablation
One year
Arterial hypertension
Presence of arterial hypertension on the day of flutter ablation
One day
Antecedents of stroke
Antecedents of stroke
One day
Stroke after flutter ablation
Occurence of stroke after the flutter ablation
One year
Antecedents of peripheric thromboembolic events
Antecedents of thromboembolic events on the day of flutter ablation
One day
Peripheric thromboembolic events after flutter ablation
Thromboembolic events after flutter ablation
One year
Atrial Fibrillation apparition delay
Delay of apparition of atrial fibrillation after flutter removal
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)
One day
Left atrium size of the heart
Left atrium size of the heart at the day of flutter removal (echographic data)
One day
Pulmonary arterial pressure
Pulmonary arterial pressure at the day of flutter removal (echographic data)
One day

Study Arms (5)

Control

No atrial arrhythmia post-ablation of a flutter by radiofrequency of the isthmus of the cavotricuspid valva.