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

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00369330
• Other study ID #: AFNET-B03
• Status: Withdrawn
• Phase: N/A
• First received: August 28, 2006
• Last updated: August 31, 2012
• Start date: September 2006

Study information

• Verified date: August 2006
• Source: German Atrial Fibrillation Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• external electrical cardioversion

Locations

Country	Name	City	State
Germany	Medizinische Klinik und Poliklinik II, University Hospital of Bonn	Bonn

Sponsors (2)

Lead Sponsor	Collaborator
German Atrial Fibrillation Network	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

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

External Links

•   Homepage of german atrial fibrillation network