Clinical trial NCT00369330: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
early cardioversion
electrical cardioversion
Lead sponsor: Atrial Fibrillation Network
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2006-08-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
measure: Number of electrical cardioversion because of AF
measure: Need to initiate or change medical antiarrhythmic treatment because of recurrence of AF
measure: Number and length of stay of hospitalization because of cardiovascular reasons
measure: Number of thromboembolic events
measure: Number of therapy non-responder and early recurrence of AF
measure: AF burden
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Medizinische Klinik und Poliklinik II, University Hospital of Bonn
Study officials:
affiliation: Medizinische Klinik und Poliklinik II - Universitätsklinikum Bonn, Bonn, Germany
name: Thorsten Lewalter, MD
role: PRINCIPAL_INVESTIGATOR
References: