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OpenTrials
Completed

NCT Number: NCT05148923

Comparison of Two DCCV Algorithms - Rational Versus Maximum Fixed Energy

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nemocnice AGEL Trinec-Podlesi

Třinec, Česká Republika (Česko), 73961, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Direct current cardioversion (DCCV)

Procedure

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

Primary outcomes

  1. Heart rhythm after DCCV

    Time frame: one minute after DCCV

    sinus rhythm

  2. Incidence of Neurological Adverse Events

    Time frame: two hours after DCCV

    neurological complications

Secondary outcomes

  1. Incidence of skin changes

    Time frame: two hours after DCCV

    none, skin redness, skin burns

  2. Chest pain

    Time frame: one day after DCCV

    0-10 scale of pain severity

Sponsors and collaborators

Lead sponsor

Nemocnice AGEL Trinec-Podlesi a.s.

Other

Registry information

Acronym: PROTOCOLENERGY

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 8, 2021
Registry last updated
Aug 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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