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

August 31, 2012 updated by: Atrial Fibrillation Network

Prospective, Randomized Parallel-group Study for Evaluation of Impact of Early Versus Delayed Cardioversion of Acute Atrial Fibrillation on Further Clinical Course

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bonn, Germany, 53105
        • Medizinische Klinik und Poliklinik II, University Hospital of Bonn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Secondary Outcome Measures

Outcome Measure
AF burden
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atrial Fibrillation Network

Collaborators

German Federal Ministry of Education and Research

Investigators

  • Principal Investigator: Thorsten Lewalter, MD, Medizinische Klinik und Poliklinik II - Universitätsklinikum Bonn, Bonn, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Study Registration Dates

First Submitted

August 28, 2006

First Submitted That Met QC Criteria

August 28, 2006

First Posted (Estimate)

August 29, 2006

Study Record Updates

Last Update Posted (Estimate)

September 3, 2012

Last Update Submitted That Met QC Criteria

August 31, 2012

Last Verified

August 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFNET-B03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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