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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

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.

Conditions

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Atrial Fibrillation

Keywords

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atrial fibrillation early cardioversion electrical cardioversion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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external electrical cardioversion

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Thorsten Lewalter, MD

Role: PRINCIPAL_INVESTIGATOR

Medizinische Klinik und Poliklinik II - Universitätsklinikum Bonn, Bonn, Germany

Locations

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Medizinische Klinik und Poliklinik II, University Hospital of Bonn

Bonn, , Germany

Site Status

Countries

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Germany

Other Identifiers

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AFNET-B03

Identifier Type: -

Identifier Source: org_study_id