Comparison of Two DCCV Algorithms - Rational Versus Maximum Fixed Energy (PROTOCOLENERGY)

Nemocnice AGEL Trinec-Podlesi a.s.

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Procedure: Direct current cardioversion (DCCV)

Study type: Interventional

Funder types: Other

Identifiers

NCT05148923

IGS202009

Details and patient eligibility

About

Direct current cardioversion (DCCV) is a widespread method to restore sinus rhythm in patients with atrial fibrillation. It is a safe and effective method of treating atrial fibrillation. In this study, the investigators want to compare two algorithms. The rational one, with lower initial energy and the second one with the maximum possible shock energy.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients must have atrial fibrillation or atrial tachycardia.
2. Patients must be on therapeutic anticoagulation at least three weeks prior to DCCV or undergo esophageal echocardiography to rule out intracardiac thrombus.
3. Patients come on an empty stomach.
4. Patients must be over 18 years of age.
5. Patients must provide verbal and written informed consent to participate in the study.

Exclusion criteria

1. Omitting oral anticoagulant treatment in the last three weeks.
2. Unclear time of onset of palpitations in acute patients without anticoagulation therapy.
3. A different type of arrhythmia than atrial fibrillation or atrial tachycardia.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

Rational energy algorithm

Active Comparator group

Description:

150 J, 360 J, 360 J biphasic DCCV

Treatment:

Procedure: Direct current cardioversion (DCCV)

Maximum fixed energy algorithm

Active Comparator group

Description:

3x 360 J biphasic DCCV

Treatment:

Procedure: Direct current cardioversion (DCCV)