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

This study has been withdrawn prior to enrollment.
(withdrawn because of insufficient financial capacities)
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by:
German Atrial Fibrillation Network
ClinicalTrials.gov Identifier:
NCT00369330
First received: August 28, 2006
Last updated: August 31, 2012
Last verified: August 2006
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Device: external electrical cardioversion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective, Randomized Parallel-group Study for Evaluation of Impact of Early Versus Delayed Cardioversion of Acute Atrial Fibrillation on Further Clinical Course

Resource links provided by NLM:


Further study details as provided by German Atrial Fibrillation Network:

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

Enrollment: 0
Study Start Date: September 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00369330

Locations
Germany
Medizinische Klinik und Poliklinik II, University Hospital of Bonn
Bonn, Germany, 53105
Sponsors and Collaborators
German Atrial Fibrillation Network
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Thorsten Lewalter, MD Medizinische Klinik und Poliklinik II - Universitätsklinikum Bonn, Bonn, Germany
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00369330     History of Changes
Other Study ID Numbers: AFNET-B03
Study First Received: August 28, 2006
Last Updated: August 31, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by German Atrial Fibrillation Network:
atrial fibrillation
early cardioversion
electrical cardioversion

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 27, 2014