Status:
COMPLETED
Comparison of Efficacy and Safety of Two Biphasic Defibrillators in Cardioversion of Atrial Fibrillation
Lead Sponsor:
University National Heart Hospital
Conditions:
Atrial Fibrillation
Arrythmia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Background: Biphasic truncated exponential (BTE) waveforms are standard for cardiac defibrillation and synchronized cardioversion up to date. BTE waveforms differ by design characteristics and technol...
Detailed Description
Background: External defibrillators are routinely used for treatment of lethal ventricular arrhythmias (defibrillation) as well as atrial and non-lethal ventricular arrhythmias (synchronized CVS). Co...
Eligibility Criteria
Inclusion
- (indications for elective cardioversion of atrial fibrillation):
- Patients \> 18 years old and:
- Symptomatic AFIB with a duration of less than 12 months - EHRA score 2-4
- Symptomatic first detected AFIB - EHRA score 2-4
- Persistent AFIB after successful causal therapy
Exclusion
- The patients are excluded if one of these conditions is present:
- Patients with atrial flutter
- Spontaneous HR \<60/min
- Digitalis intoxication
- Impossibility to maintain sinus rhythm irrespective to antiarrhythmic therapy and frequent cardioversions
- Conduction disturbances (without fascicular block and AV block 1 degree) in patients without pacemaker
- Asymptomatic patients with AFIB for \> 1 year
- Thyroid dysfunction: euthyroid status of at least one month is required (TSH is measured).
- Thrombosis in cardiac cavities, assessment performed using Transesophageal echocardiography (TEE)
- Spontaneous echo contrast \> 2 degree (TEE)
- Patients with planned cardiac operation in the next three months
- Patients with embolic event in the last three months
- Patients \<18 years of age
- Pregnancy
Key Trial Info
Start Date :
February 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 6 2020
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04032678
Start Date
February 5 2019
End Date
August 6 2020
Last Update
August 25 2020
Active Locations (1)
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1
University National Heart Hospital
Sofia, Bulgaria, 1309