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

July 31, 2023 updated by: Lucjan Rucki, Nemocnice AGEL Trinec-Podlesi a.s.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Czechia
    • Česká Republika (Česko)
      • Trinec, Česká Republika (Česko), Czechia, 73961
        • Nemocnice AGEL Trinec-Podlesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Rational energy algorithm
150 J, 360 J, 360 J biphasic DCCV
Procedure: Direct current cardioversion (DCCV)
DCCV is a safe and effective method of treating atrial fibrillation.
Active Comparator: Maximum fixed energy algorithm
3x 360 J biphasic DCCV
Procedure: Direct current cardioversion (DCCV)
DCCV is a safe and effective method of treating atrial fibrillation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rhythm after DCCV
Time Frame: one minute after DCCV
sinus rhythm
one minute after DCCV
Incidence of Neurological Adverse Events
Time Frame: two hours after DCCV
neurological complications
two hours after DCCV

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of skin changes
Time Frame: two hours after DCCV
none, skin redness, skin burns
two hours after DCCV
Chest pain
Time Frame: one day after DCCV
0-10 scale of pain severity
one day after DCCV

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nemocnice AGEL Trinec-Podlesi a.s.

Investigators

  • Principal Investigator: Lucjan Rucki, MD, Nemocnice AGEL Trinec-Podlesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

November 25, 2021

First Submitted That Met QC Criteria

November 25, 2021

First Posted (Actual)

December 8, 2021

Study Record Updates

Last Update Posted (Actual)

August 2, 2023

Last Update Submitted That Met QC Criteria

July 31, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IGS202009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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