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

Atrial Fibrillation Network

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Atrial Fibrillation

Interventions

external electrical cardioversionDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Medizinische Klinik und Poliklinik II, University Hospital of Bonn

Bonn, Germany

Outcomes

Secondary Outcomes

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

Data from ClinicalTrials.gov

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