Status:
UNKNOWN
BTE and Pulsed Waveforms for Cardioversion of Atrial Fibrillation - Escalation Strategy and Manual Pressure
Lead Sponsor:
University National Heart Hospital
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Background: A Danish study raised the question of the usefulness of escalating energy protocols compared to fixed high-energy protocols. Maximal energies are usually the final choice of the physicians...
Detailed Description
Background Commercially available defibrillators generate direct current (DC) shock with various waveforms using distinct technologies. These waveforms are suggested to have different efficacy and saf...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Indications for elective cardioversion of atrial fibrillation
- Patients \> 18 years old and:
- Symptomatic AFIB with a duration of less than 12 months and EHRA score 2-4
- Symptomatic first detected AFIB and EHRA score 2-4
- Persistent AFIB after successful causal therapy
- Rare recurrences of AFIB with long periods of sinus rhythm
- Impossibility to reach a sustained normal ventricular rate in AFIB
- Exclusion Criteria:
- 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
- Pregnant woman
Exclusion
Key Trial Info
Start Date :
January 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2024
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT05316753
Start Date
January 20 2022
End Date
June 30 2024
Last Update
July 25 2022
Active Locations (1)
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1
University National Heart Hospital
Sofia, Bulgaria, 1309