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Completed

NCT Number: NCT05084495

The Use of Flecainide for Treatment of Atrial Fibrillation

This prospective observational study will include patients with atrial fibrillation that has indication for treatement with flecainide. Included patients are followed during a 12 month period. During the follow-up period they will have four clinical visits, during which clinical data, advanced echocardiographic data (strain and speckle tracking) and ECGs (Glasgow criteria) will be collected. These data will be analysed in relation to outcome parameters as: maintaining a normal sinus rhythm (arrythmia free health status), number of AF-free months, chances of successful electrical cardioversion, frequency of side effects, risk of pro-arrhythmias and mortality. The importance of these two analyses is to improve the use of flecainide. Hence, today patients with low benefit compared to risk of adverse events are inappropriately treated with flecainide with the "trial and error" approach currently used. On the other hand flecainide is currently underutilized, and patients denied the treatment that could improve their quality of life, prognosis and reduce their risk of cardiovascular adverse events. By investigating novel and promising parameters there is the potential of a better prediction of initiating safe and accurate anti-arrhythmic therapy for patients with atrial fibrillation.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Sciences, Helsingborg Medical Faculty Lund University

Helsingborg, Skåne County, 25187, Sweden

About this study

Study synopsis for the Tambocor Prospective study

Inclusion: Patients with atrial fibrillation that admitted to the ward for prior to start of flecainide initiation.

Ethics: Informed Concent prior to inclusion.

Follow up after baseline: 4 visits during 12 month.

End points : Side effects that lead to discontinuation of flecainide. Persistent AF that lead to discontinuation of flecainide.

Evaluated parameters: 12 lead ECG, ECHO: LA, LV, HV strain , Dynamic Heart model: LV and RV.

The follow up visits:

Baseline: Normal ECHO after the first dose of flecainide, ECG and Questionnaire

4 Weeks: Normal ECHO + Protocol ECHO (LA, LV, HV strain , Dynamic Heart model: LV and RV) and Questionnaire.

6 month: Normal ECHO + Protocol ECHO (LA, LV, HV strain , Dynamic Heart model: LV and RV) and Questionnaire.

12 month: Normal ECHO + Protocol ECHO (LA, LV, HV strain , Dynamic Heart model: LV and RV) and Questionnaire.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients with written informed consent who are eligible for flecainide treatment for atrial fibrillation.
  • The patients must be followed at the Skånes hospitals northwest and Skånes university hospitals.
  • Age >18 years

Exclusion criteria

  • Flecainide treatment with other indication than atrial fibrillation (including atrial flutter).
  • No secure date for treatment start.
  • Age <18 years

Treatment and study plan

Global peak atrial longitudinal strain and ECG

Diagnostic Test

During the follow-up period the patient will have four clinical visits, during which clinical data, advanced echocardiographic data (strain and speckle tracking) and ECGs (Glasgow criteria) will be collected

Primary outcomes

  1. Arrythmia free health status

    Time frame: During the 12 month follow up

    Can we predict who will maintain a normal sinus rhythm prior to initiation of flecainide? treatment start

Secondary outcomes

  1. Number of AF-free months

    Time frame: During the 12 month follow up

    Can we improve the number of AF-free months by a better prediction model

  2. Frequency of side effects

    Time frame: During the 12 month follow up

    Can we improve the diagnostic accuracy to reduce the frequency of side effects

  3. Risk of pro-arrhythmias

    Time frame: During the 12 month follow up

    Can we improve the diagnostic accuracy to reduce risk of pro-arrhythmias

  4. Mortality

    Time frame: During the 12 month follow up

    Can we improve the diagnostic accuracy to reduce risk mortality

Sponsors and collaborators

Lead sponsor

Lund University

Other

Registry information

Official study title

Can Global Peak Longitudinal Strain Measurements in Combination With Non-invasive ECG Parameters Predict the Success or Failure of Flecainide Treatment for Atrial Fibrillation Patients?

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 19, 2021
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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