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

Not Applicable

Withdrawn

• Conditions: Atrial Fibrillation

• Registration Number: NCT00369330
• Lead Sponsor: Atrial Fibrillation Network

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.

Study Timeline

• Status Verified: 2006-08
• Study First Submitted: 2006-08-28
• Study First Submitted QC: 2006-08-28
• Study First Posted: 2006-08-29
• Study Start: 2006-09
• Last Update Submitted: 2012-08-31
• Last Update Posted: 2012-09-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

Medizinische Klinik und Poliklinik II, University Hospital of Bonn; 🇩🇪 Bonn, Germany