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Comparison of Two DCCV Algorithms - Rational Versus Maximum Fixed Energy

Comparison of Two DCCV Algorithms - Rational Versus Maximum Fixed Energy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05148923
Acronym
PROTOCOLENERGY
Enrollment
300
Registered
2021-12-08
Start date
2022-01-01
Completion date
2022-12-31
Last updated
2023-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

DCCV, atrial fibrillation

Brief summary

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.

Interventions

PROCEDUREDirect current cardioversion (DCCV)

DCCV is a safe and effective method of treating atrial fibrillation.

Sponsors

Nemocnice AGEL Trinec-Podlesi a.s.
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Heart rhythm after DCCVone minute after DCCVsinus rhythm
Incidence of Neurological Adverse Eventstwo hours after DCCVneurological complications

Secondary

MeasureTime frameDescription
Incidence of skin changestwo hours after DCCVnone, skin redness, skin burns
Chest painone day after DCCV0-10 scale of pain severity

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026