Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00369330
Recruitment Status : Withdrawn (withdrawn because of insufficient financial capacities)
First Posted : August 29, 2006
Last Update Posted : September 3, 2012
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by:
Atrial Fibrillation Network

Tracking Information
First Submitted Date  ICMJE August 28, 2006
First Posted Date  ICMJE August 29, 2006
Last Update Posted Date September 3, 2012
Study Start Date  ICMJE September 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE
 (submitted: August 28, 2006)
Time to first recurrence of AF
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2006)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE KONVERT-AF - Relevance of Point in Time for Conversion of Acute Atrial Fibrillation
Official Title  ICMJE Prospective, Randomized Parallel-group Study for Evaluation of Impact of Early Versus Delayed Cardioversion of Acute Atrial Fibrillation on Further Clinical Course
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE Device: external electrical cardioversion
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: August 31, 2012)
0
Original Enrollment  ICMJE
 (submitted: August 28, 2006)
380
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00369330
Other Study ID Numbers  ICMJE AFNET-B03
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Atrial Fibrillation Network
Collaborators  ICMJE German Federal Ministry of Education and Research
Investigators  ICMJE
Principal Investigator: Thorsten Lewalter, MD Medizinische Klinik und Poliklinik II - Universitätsklinikum Bonn, Bonn, Germany
PRS Account Atrial Fibrillation Network
Verification Date August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP