Atrial FibrillationPROTOCOLENERGYNCT05148923
Comparison of Two DCCV Algorithms - Rational Versus Maximum Fixed Energy
A study testing Direct current cardioversion (DCCV) in people with Atrial Fibrillation, run by Nemocnice AGEL Trinec-Podlesi a.s. at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Direct current cardioversion (DCCV)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jan 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Nemocnice AGEL Trinec-Podlesi
Třinec, Česká Republika (Česko), 73961
About this study
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.
- Conditions
- Atrial Fibrillation
- Being tested
- Direct current cardioversion (DCCV)
- Keywords
- DCCV, atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct current cardioversion (DCCV)Procedure or surgery
DCCV is a safe and effective method of treating atrial fibrillation.
| Study group | Role | What they receive |
|---|---|---|
| Rational energy algorithm | Active comparator | 150 J, 360 J, 360 J biphasic DCCV Receives: Procedure: Direct current cardioversion (DCCV) |
| Maximum fixed energy algorithm | Active comparator | 3x 360 J biphasic DCCV Receives: Procedure: Direct current cardioversion (DCCV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rhythm after DCCV
sinus rhythm
Measured: one minute after DCCV
Incidence of Neurological Adverse Events
neurological complications
Measured: two hours after DCCV
Secondary outcomes (2)
Incidence of skin changes
none, skin redness, skin burns
Measured: two hours after DCCV
Chest pain
0-10 scale of pain severity
Measured: one day after DCCV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start1 Jan 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemocnice AGEL Trinec-Podlesi a.s.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucjan Rucki, Nemocnice AGEL Trinec-Podlesi a.s.
- Investigators
- Lucjan Rucki, MD, Principal investigator, Nemocnice AGEL Trinec-Podlesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05148923
- Sponsor's protocol ID
- IGS202009
- Acronym
- PROTOCOLENERGY
- Status last verified
- Jul 2023
- First submitted
- 25 Nov 2021
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38857688
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two DCCV Algorithms - Rational Versus Maximum Fixed Energy
- ClinicalTrials.gov ID
- NCT05148923
- Acronym / sponsor ID
- PROTOCOLENERGY / IGS202009
- Conditions
- Atrial Fibrillation
- Keywords
- DCCV, atrial fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Nemocnice AGEL Trinec-Podlesi a.s.University, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rational energy algorithm | Active comparator | Procedure: Direct current cardioversion (DCCV)150 J, 360 J, 360 J biphasic DCCV |
| Maximum fixed energy algorithm | Active comparator | Procedure: Direct current cardioversion (DCCV)3x 360 J biphasic DCCV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct current cardioversion (DCCV)DCCV is a safe and effective method of treating atrial fibrillation. | Procedure or surgery | Maximum fixed energy algorithm, Rational energy algorithm |
Primary outcome
Heart rhythm after DCCV
Time frame: one minute after DCCV
sinus rhythm
Incidence of Neurological Adverse Events
Time frame: two hours after DCCV
neurological complications
2 secondary outcomes
Incidence of skin changes
Time frame: two hours after DCCV
Chest pain
Time frame: one day after DCCV
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Derived from this study: PubMed 38857688Roman 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.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
Atrial Fibrillation
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
Not yet recruitingPhase 4
Sacubitril/Valsartan vs Standard Treatment for Preventing Atrial Fibrillation Recurrence After Catheter Ablation in Persistent Atrial Fibrillation Patients With Without Hypertension
Atrial Fibrillation (Persistent), Catheter Ablation
RecruitingObservational study
A Study of Varipulse Catheter in Participants With Paroxysmal Atrial Fibrillation Under Optimized Sedation
Atrial Fibrillation
RecruitingPhase 3
Thrombolysis in Factor Xa-inhibitors Trial
Stroke, Stroke (in Patients With Atrial Fibrillation)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucjan Rucki, MD principal investigator
Nemocnice AGEL Trinec-Podlesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct current cardioversion (DCCV) in people with Atrial Fibrillation, run by Nemocnice AGEL Trinec-Podlesi a.s. at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rhythm after DCCV (time frame: one minute after DCCV). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05148923, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.