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

Primary Purpose

Atrial Fibrillation

Status
Withdrawn
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
external electrical cardioversion
Sponsored by
Atrial Fibrillation Network
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, early cardioversion, electrical cardioversion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Medizinische Klinik und Poliklinik II, University Hospital of Bonn

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

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

Full Information

First Posted
August 28, 2006
Last Updated
August 31, 2012
Sponsor
Atrial Fibrillation Network
Collaborators
German Federal Ministry of Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT00369330
Brief Title
KONVERT-AF - Relevance of Point in Time for Conversion of Acute Atrial Fibrillation
Official Title
Prospective, Randomized Parallel-group Study for Evaluation of Impact of Early Versus Delayed Cardioversion of Acute Atrial Fibrillation on Further Clinical Course
Study Type
Interventional

2. Study Status

Record Verification Date
August 2006
Overall Recruitment Status
Withdrawn
Why Stopped
withdrawn because of insufficient financial capacities
Study Start Date
September 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Atrial Fibrillation Network
Collaborators
German Federal Ministry of Education and Research

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation, early cardioversion, electrical cardioversion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
external electrical cardioversion
Secondary Outcome Measure Information:
Title
Number of electrical cardioversion because of AF
Title
Need to initiate or change medical antiarrhythmic treatment because of recurrence of AF
Title
Number and length of stay of hospitalization because of cardiovascular reasons
Title
Number of thromboembolic events
Title
Number of therapy non-responder and early recurrence of AF
Title
AF burden

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thorsten Lewalter, MD
Organizational Affiliation
Medizinische Klinik und Poliklinik II - Universitätsklinikum Bonn, Bonn, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medizinische Klinik und Poliklinik II, University Hospital of Bonn
City
Bonn
ZIP/Postal Code
53105
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://www.kompetenznetz-vorhofflimmern.de
Description
Homepage of german atrial fibrillation network

Learn more about this trial

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

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