KONVERT-AF - Relevance of Point in Time for Conversion of Acute Atrial Fibrillation

Study Overview
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Brief Summary
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To investigate if in acute symptomatic atrial fibrillation (AF) the early (>2 hrs but within 12 hrs of the beginning of the arrhythmia) electrical cardioversion leads to a longer recurrence-free interval than the delayed cardioversion (> 36 hrs but < 48 hrs after the beginning of the arrhythmia) within the first 3 months after cardioversion.

Detailed Description
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So far it is unknown if early or delayed cardioversion is most beneficial for patient outcome and which strategy is best to prevent recurrence of AF. The KONVERT-AF trial investigates if in acute symptomatic AF the early (>2 hrs but within 12 hrs of the beginning of the arrhythmia) electrical cardioversion leads to a longer recurrence-free interval than the delayed cardioversion (> 36 hrs but < 48 hrs after the beginning of the arrhythmia) within the first 3 months after cardioversion. Primary endpoint is the time to the first recurrence of AF. The KONVERT-AF trial will be conducted as prospective, randomized, non-blinded multicentre study. It is planned to include 380 patients in 10-20 recruitment centres.

Official Title
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Prospective, Randomized Parallel-group Study for Evaluation of Impact of Early Versus Delayed Cardioversion of Acute Atrial Fibrillation on Further Clinical Course

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: external electrical cardioversion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: documented AF that began between 2 and 8 hrs before randomization indication for electrical cardioversion. age above 18 yrs written informed consent Exclusion Criteria: AF caused by not adequately treated reversible conditions(e.g. myocardial infarction, thyrotoxicosis, ethanol intoxication, infection, pericarditis, surgery) newly initiated (i.e. within 7 days before randomization) antiarrhythmic agents of class I, II and/or III catheter ablation of AF within 3 months before randomization pacemaker or icd myocardial infarction within 3 months before randomization urgent need to cardioversion of AF because of associated potentially dangerous symptoms such as chest pain, syncope, dyspnea contraindications for therapy with vitamin k-antagonists intracardial thrombus primary indication for pharmacological cardioversion in females: pregnancy, lactation period or no sufficient contraception within last 3 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: external electrical cardioversion|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of electrical cardioversion because of AF |  |  | 
| Need to initiate or change medical antiarrhythmic treatment because of recurrence of AF |  |  | 
| Number and length of stay of hospitalization because of cardiovascular reasons |  |  | 
| Number of thromboembolic events |  |  | 
| Number of therapy non-responder and early recurrence of AF |  |  | 
| AF burden |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, early cardioversion, electrical cardioversion