Atrial Fibrillation Clinical Trial
Official title:
Prospective, Randomized Parallel-group Study for Evaluation of Impact of Early Versus Delayed Cardioversion of Acute Atrial Fibrillation on Further Clinical Course
NCT number | NCT00369330 |
Other study ID # | AFNET-B03 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | August 28, 2006 |
Last updated | August 31, 2012 |
Start date | September 2006 |
Verified date | August 2006 |
Source | German Atrial Fibrillation Network |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Medizinische Klinik und Poliklinik II, University Hospital of Bonn | Bonn |
Lead Sponsor | Collaborator |
---|---|
German Atrial Fibrillation Network | German Federal Ministry of Education and Research |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Secondary | Number of electrical cardioversion because of AF | |||
Secondary | Need to initiate or change medical antiarrhythmic treatment because of recurrence of AF | |||
Secondary | Number and length of stay of hospitalization because of cardiovascular reasons | |||
Secondary | Number of thromboembolic events | |||
Secondary | Number of therapy non-responder and early recurrence of AF | |||
Secondary | AF burden |
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