Identification of Risk Factors for Atrial Fibrillation After Ablation of an Atrial Flutter by Radiofrequency of the Cavotricuspid Isthmus.

Flutter Clinical Trial

Official title:

Retrospective Study to Identify Risk Factors for Atrial Fibrillation After Ablation of Atrial Flutter by Radiofrequency of the Cavotricuspid Isthmus.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03919097
• Other study ID #: CHUB-Fayad
• Status: Completed
• Start date: January 8, 2019
• Est. completion date: November 20, 2019

Study information

• Verified date: July 2022
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 20, 2019
• Est. primary completion date: November 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

None

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Flutter
• Flutter

Intervention

Other:
• Medical Data extraction
Data extraction from the patient's Medical Files

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
José Castro

Country where clinical trial is conducted

Belgium, 

Outcome

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