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

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ClinicalTrials.gov Identifier: NCT03919097
Recruitment Status : Unknown
Verified April 2019 by José Castro, Brugmann University Hospital.
Recruitment status was:  Recruiting
First Posted : April 18, 2019
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
José Castro, Brugmann University Hospital

Study Description
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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.


Condition or disease Intervention/treatment
Flutter Other: Medical Data extraction

Study Design
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Study Type : Observational
Estimated Enrollment : 987 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Study to Identify Risk Factors for Atrial Fibrillation After Ablation of Atrial Flutter by Radiofrequency of the Cavotricuspid Isthmus.
Actual Study Start Date : January 8, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Age at ablation [ Time Frame: One day ]
    Age of the patient at the date of the flutter ablation

  2. Gender [ Time Frame: One day ]
    Gender of the patient at the date of the flutter ablation

  3. Antecedents of ischemic cardiomyopathy [ Time Frame: One day ]
    Antecedents of ischemic cardiomyopathy (yes/no) at the date of flutter ablation

  4. Antecedents of cardiomyopathy [ Time Frame: One day ]
    Antecedents of cardiomyopathy (yes/no) at the date of flutter ablation

  5. Antecedents of dilated cardiomyopathy [ Time Frame: One day ]
    Antecedents of dilated cardiomyopathy (yes/no) at the date of flutter ablation

  6. Diabetes [ Time Frame: One day ]
    Diabetes diagnosis (yes/no) at the date of flutter ablation

  7. Chronic pulmonal disease [ Time Frame: One day ]
    Chronic pulmonal disease diagnosed at the date of flutter ablation

  8. Cardiac surgery antecedents [ Time Frame: One day ]
    Presence of cardiac surgery antecedents at the date of flutter ablation

  9. Atrial fibrillation antecedents [ Time Frame: One day ]
    Antecedents of Atrial fibrillation at the date of flutter ablation

  10. Beta-blockers post-ablation [ Time Frame: One day ]
    Prescription of Beta-Blockers after the flutter ablation (yes/no)

  11. Amiodarone post-ablation [ Time Frame: One year ]
    Prescription of amiodarone after the flutter ablation (yes/no)

  12. Class I antiarrhythmic drugs post-ablation [ Time Frame: One year ]
    Prescription of Class I antiarrhythmic drugs post-ablation

  13. Arterial hypertension [ Time Frame: One day ]
    Presence of arterial hypertension on the day of flutter ablation

  14. Antecedents of stroke [ Time Frame: One day ]
    Antecedents of stroke

  15. Stroke after flutter ablation [ Time Frame: One year ]
    Occurence of stroke after the flutter ablation

  16. Antecedents of peripheric thromboembolic events [ Time Frame: One day ]
    Antecedents of thromboembolic events on the day of flutter ablation

  17. Peripheric thromboembolic events after flutter ablation [ Time Frame: One year ]
    Thromboembolic events after flutter ablation

  18. Atrial Fibrillation apparition delay [ Time Frame: Up to one year ]
    Delay of apparition of atrial fibrillation after flutter removal

  19. 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)

  20. Left atrium size of the heart [ Time Frame: One day ]
    Left atrium size of the heart at the day of flutter removal (echographic data)

  21. Pulmonary arterial pressure [ Time Frame: One day ]
    Pulmonary arterial pressure at the day of flutter removal (echographic data)


Eligibility Criteria
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Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated at the CHU Brugmann Hospital for flutter ablation by radiofrequency between 1996 and 2018.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

None

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03919097


Contacts
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Contact: Georges Fayad, MD 3224772679 Georges.FAYAD@chu-brugmann.be

Locations
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Belgium
CHU Brugmann Recruiting
Brussels, Belgium, 1020
Contact: Georges Fayad, MD       Georges.FAYAD@chu-brugmann.be   
Principal Investigator: Gerges Fayad         
Sponsors and Collaborators
José Castro
Investigators
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Principal Investigator: Georges Fayad, MD CHU Brugmann
More Information
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Responsible Party: José Castro, Head of cardiology clinic, Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT03919097    
Other Study ID Numbers: CHUB-Fayad
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Atrial Flutter
Arrhythmias, Cardiac
 Heart Diseases
Cardiovascular Diseases
Pathologic Processes