Atrial Fibrillation
Conditions
Keywords
atrial fibrillation, early cardioversion, electrical cardioversion
Brief summary
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
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.
Interventions
DEVICEexternal electrical cardioversion
Sponsors
German Federal Ministry of Education and Research
Atrial Fibrillation Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Secondary
| Measure | 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 | — |
Countries
Germany
Outcome results
None listed