Back to resultsComparison of Two DCCV Algorithms - Rational Versus Maximum Fixed Energy (PROTOCOLENERGY)
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Direct current cardioversion (DCCV)
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring DCCV, atrial fibrillation
Eligibility Criteria
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.
Sites / Locations
- Nemocnice AGEL Trinec-Podlesi
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Rational energy algorithm
Maximum fixed energy algorithm
Arm Description
150 J, 360 J, 360 J biphasic DCCV
3x 360 J biphasic DCCV
Outcomes
Primary Outcome Measures
Heart rhythm after DCCV
sinus rhythm
Incidence of Neurological Adverse Events
neurological complications
Secondary Outcome Measures
Incidence of skin changes
none, skin redness, skin burns
Chest pain
0-10 scale of pain severity
Full Information
NCT ID
NCT05148923
First Posted
November 25, 2021
Last Updated
July 31, 2023
Sponsor
Nemocnice AGEL Trinec-Podlesi a.s.
1. Study Identification
Unique Protocol Identification Number
NCT05148923
Brief Title
Comparison of Two DCCV Algorithms - Rational Versus Maximum Fixed Energy
Acronym
PROTOCOLENERGY
Official Title
Comparison of Two DCCV Algorithms - Rational Versus Maximum Fixed Energy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nemocnice AGEL Trinec-Podlesi a.s.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
DCCV, atrial fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rational energy algorithm
Arm Type
Active Comparator
Arm Description
150 J, 360 J, 360 J biphasic DCCV
Arm Title
Maximum fixed energy algorithm
Arm Type
Active Comparator
Arm Description
3x 360 J biphasic DCCV
Intervention Type
Procedure
Intervention Name(s)
Direct current cardioversion (DCCV)
Intervention Description
DCCV is a safe and effective method of treating atrial fibrillation.
Primary Outcome Measure Information:
Title
Heart rhythm after DCCV
Description
sinus rhythm
Time Frame
one minute after DCCV
Title
Incidence of Neurological Adverse Events
Description
neurological complications
Time Frame
two hours after DCCV
Secondary Outcome Measure Information:
Title
Incidence of skin changes
Description
none, skin redness, skin burns
Time Frame
two hours after DCCV
Title
Chest pain
Description
0-10 scale of pain severity
Time Frame
one day after DCCV
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucjan Rucki, MD
Organizational Affiliation
Nemocnice AGEL Trinec-Podlesi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nemocnice AGEL Trinec-Podlesi
City
Trinec
State/Province
Česká Republika (Česko)
ZIP/Postal Code
73961
Country
Czechia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Two DCCV Algorithms - Rational Versus Maximum Fixed Energy
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