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

Atrial Fibrillation Network (AFNET)

Status

Withdrawn

Conditions

Atrial Fibrillation

Treatments

Device: external electrical cardioversion

Study type

Interventional

Funder types

Other

Identifiers

NCT00369330

AFNET-B03

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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