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

Retrospective Study to Identify Risk Factors for Atrial Fibrillation After Ablation of 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.

Study Overview

• Status: Completed
• Conditions: Flutter
• Intervention / Treatment: Other: Medical Data extraction

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1020
    • CHU Brugmann

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

5

Cohorts 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: José Castro
• Investigators: Principal Investigator: Georges Fayad, MD, CHU Brugmann

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2019
• Primary Completion (Actual): November 20, 2019
• Study Completion (Actual): November 20, 2019

Study Registration Dates

• First Submitted: April 15, 2019
• First Submitted That Met QC Criteria: April 15, 2019
• First Posted (Actual): April 18, 2019

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Atrial Flutter
• Other Study ID Numbers: CHUB-Fayad

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No