Comparison of Two DCCV Algorithms - Rational Versus Maximum Fixed Energy
PROTOCOLENERGY
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable atrial-fibrillation
Started Jan 2022
Shorter than P25 for not_applicable atrial-fibrillation
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2021
CompletedFirst Posted
Study publicly available on registry
December 8, 2021
CompletedStudy Start
First participant enrolled
January 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedAugust 2, 2023
July 1, 2023
12 months
November 25, 2021
July 31, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Heart rhythm after DCCV
sinus rhythm
one minute after DCCV
Incidence of Neurological Adverse Events
neurological complications
two hours after DCCV
Secondary Outcomes (2)
Incidence of skin changes
two hours after DCCV
Chest pain
one day after DCCV
Study Arms (2)
Rational energy algorithm
ACTIVE COMPARATOR150 J, 360 J, 360 J biphasic DCCV
Maximum fixed energy algorithm
ACTIVE COMPARATOR3x 360 J biphasic DCCV
Interventions
DCCV is a safe and effective method of treating atrial fibrillation.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nemocnice AGEL Trinec-Podlesi
Třinec, Česká Republika (Česko), 73961, Czechia
Related Publications (1)
Roman M, Lucjan R, Otakar J, Radim S, Jan C, Radek N, Miroslav H, Libor S, Bogna JG, Jan H, Martin F. Optimizing Energy Delivery in Cardioversion: A Randomized PROTOCOLENERGYTrial of 2 Different Algorithms in Patients With Atrial Fibrillation. Can J Cardiol. 2024 Nov;40(11):2130-2141. doi: 10.1016/j.cjca.2024.06.003. Epub 2024 Jun 8.
PMID: 38857688DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lucjan Rucki, MD
Nemocnice AGEL Trinec-Podlesi
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 25, 2021
First Posted
December 8, 2021
Study Start
January 1, 2022
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
August 2, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share