Atrial Fibrillation (AF)LE-HI-CVNCT07884253
Energy Dose and Cardioversion Outcomes in AF
A study testing Synchronized Electrical Cardioversion With Different Energy Strategies and Conventional Step-Up Energy Cardioversion in people with Atrial Fibrillation (AF), run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
This multicenter, randomized study will compare two electrical cardioversion energy strategies in adults with atrial fibrillation who are scheduled to undergo cardioversion during atrial fibrillation ablation or within 3 months after ablation. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Synchronized Electrical Cardioversion With Different Energy Strategies and Conventional Step-Up Energy Cardioversion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of atrial fibrillation Age 18 to 80 years, inclusive.
Who cannot join
- Severe cardiac disease, such as heart failure or valvular heart disease. Hemodynamically unstable atrial fibrillation. Severe hepatic or renal impairment. Unable to tolerate electrical cardioversion. Untreated hyperthyroidism. Pregnant. Previously enrolled in this study. Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Low- Versus High-Energy Electrical Cardioversion for Atrial Fibrillation: A Clinical Outcome ComparisonEnergy Dose and Cardioversion Outcomes in AF
This multicenter, randomized study will compare two electrical cardioversion energy strategies in adults with atrial fibrillation who are scheduled to undergo cardioversion during atrial fibrillation ablation or within 3 months after ablation. Eligible participants will be 18 to 80 years old, have a body mass index of at least 25 kg/m², and weigh more than 60 kg.
Participants will be randomly assigned to one of two groups. The first group will receive an initial shock of 150 joules, increased to 200 joules if needed. The second group will receive an initial shock based on body weight: 300 joules for participants weighing less than 90 kg and 360 joules for those weighing 90 kg or more. If the initial shock does not restore normal heart rhythm, further shocks will be delivered according to the study protocol.
The study will compare the proportion of participants in each group whose normal heart rhythm is restored shortly after cardioversion and whose rhythm remains stable. The study team will also record complications, changes in selected laboratory measures and quality of life, medication use, and treatment costs.
Read the detailed description
Electrical cardioversion is commonly used to restore normal heart rhythm in patients with atrial fibrillation. The energy level used during cardioversion may affect both the likelihood of restoring normal rhythm and the risk of complications. A lower initial energy may reduce exposure to high-energy shocks but may be less effective and require additional shocks. A higher initial energy selected according to body weight may improve cardioversion success, particularly in patients with higher body mass, but its effects on safety and other clinical outcomes require further evaluation.
This multicenter randomized study will compare a conventional step-up energy strategy with a body weight-based higher-energy strategy in patients with atrial fibrillation who are scheduled to undergo electrical cardioversion. The study will assess cardioversion success and maintenance of normal rhythm, as well as safety outcomes and other measures described in the study record. The results may help inform energy selection for cardioversion in this patient population.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- Synchronized Electrical Cardioversion With Different Energy Strategies, Conventional Step-Up Energy Cardioversion
- Keywords
- Atrial fibrillation, Electrical cardioversion, Cardioversion energy, Weight-based energy, Defibrillator, Randomized controlled trial
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synchronized Electrical Cardioversion With Different Energy StrategiesOther
Participants will undergo synchronized electrical cardioversion using a defibrillator monitor. The study compares two energy strategies: a conventional step-up strategy starting at 150 J and increasing to 200 J if needed, and a body weight-based strategy starting at 300 J for participants weighing less than 90 kg or 360 J for those weighing 90 kg or more. If the initial shock is unsuccessful, additional shocks will be delivered according to the study protocol.
Conventional Step-Up Energy CardioversionOther
Participants will receive synchronized electrical cardioversion starting at 150 J. If unsuccessful, the energy will be increased to 200 J.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Step-Up Energy Group | Other | Participants will undergo synchronized electrical cardioversion starting at 150 J. If the initial shock does not restore sinus rhythm, the energy will be increased to 200 J according to the study protocol. Receives: Other: Conventional Step-Up Energy Cardioversion |
| Body Weight-Based Higher-Energy Group | Experimental | Participants will undergo synchronized electrical cardioversion using an initial energy selected according to body weight: 300 J for participants weighing less than 90 kg and 360 J for participants weighing 90 kg or more. If the initial shock does not restore sinus rhythm, further shocks will be delivered according to the study protocol. Receives: Other: Synchronized Electrical Cardioversion With Different Energy Strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
First-Shock Cardioversion Success Within 1 Minute
Proportion of participants who return to sinus rhythm within 1 minute after the first synchronized electrical shock.
Measured: Within 1 minute after the first shock
Overall Cardioversion Success Within 1 Minute
Proportion of participants who return to sinus rhythm within 1 minute after cardioversion, including any additional shocks given during the procedure.
Measured: Within 1 minute after cardioversion
First-Shock Cardioversion Success Maintained for at Least 30 Minutes
Proportion of participants who return to sinus rhythm after the first shock and maintain sinus rhythm for at least 30 minutes.
Measured: From the first shock through at least 30 minutes after restoration of sinus rhythm
Secondary outcomes (4)
Change in Cardiac Injury Biomarkers
Change from baseline in cardiac troponin and, if collected, creatine kinase and creatine kinase-MB. Baseline samples will be collected within 24 hours before cardioversion; follow-up samples will be collected 24 hours after cardioversion. Actual collection times will be recorded.
Measured: Within 24 hours before and 24 hours after cardioversion
Change in Renal Function Measures
Change from baseline in serum creatinine and blood urea nitrogen, if measured as part of the study or routine clinical care.
Measured: Within 24 hours before and 24 hours after cardioversion
Cardioversion-Related Adverse Events
Number and proportion of participants with arrhythmias, sinus node dysfunction, cardiac arrest, transient bradycardia, atrioventricular block, ventricular arrhythmia, thromboembolic events, or other serious adverse events. Events will be recorded during cardioversion and through 24 hours afterward; serious adverse events will be followed through 30 days.
Measured: During cardioversion through 24 hours after cardioversion; serious adverse events through 30 days
Skin Reaction at Electrode Sites
Skin findings at the anterior and posterior electrode sites, categorized as no redness, mild redness, or skin burn.
Measured: 2 hours after cardioversion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation (AF)Studies 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
- Model description
- Multicenter, randomized, parallel-group study comparing conventional step-up energy cardioversion with body weight-based higher-energy cardioversion.
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Shaoxing People's Hospital, The Second Affiliated Hospital of Jiaxing University, First People's Hospital of Hangzhou
- Responsible party
- Principal investigator, chengjifang, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Investigators
- Ting Yin, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of MedicineXiaoxiao Yin, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884253
- Sponsor's protocol ID
- 2026-1326
- Acronym
- LE-HI-CV
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data collected in this study will not be shared with researchers outside the study team. Data sharing has not been approved under the current study protocol and data governance arrangements.
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 38857688Schmidt AS, Lauridsen KG, Torp P, Bach LF, Rickers H, Lofgren B. Maximum-fixed energy shocks for cardioverting atrial fibrillation. Eur Heart J. 2020 Feb 1;41(5):626-631. doi: 10.1093/eurheartj/ehz585.
PubMed 31504412Nguyen ST, Belley-Cote EP, Ibrahim O, Um KJ, Lengyel A, Adli T, Qiu Y, Wong M, Sibilio S, Benz AP, Wolf A, Whitlock NJ, Gabriel Acosta J, Healey JS, Baranchuk A, McIntyre WF. Techniques improving electrical cardioversion success for patients with atrial fibrillation: a systematic review and meta-analysis. Europace. 2023 Feb 16;25(2):318-330. doi: 10.1093/europace/euac199.
PubMed 36503970
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low- Versus High-Energy Electrical Cardioversion for Atrial Fibrillation: A Clinical Outcome ComparisonEnergy Dose and Cardioversion Outcomes in AF
- ClinicalTrials.gov ID
- NCT07884253
- Acronym / sponsor ID
- LE-HI-CV / 2026-1326
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- Atrial fibrillation, Electrical cardioversion, Cardioversion energy, Weight-based energy, Defibrillator, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Shaoxing People's Hospital, The Second Affiliated Hospital of Jiaxing University, First People's Hospital of Hangzhou
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 20 Oct 2026 (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.
This multicenter, randomized study will compare two electrical cardioversion energy strategies in adults with atrial fibrillation who are scheduled to undergo cardioversion during atrial fibrillation ablation or within 3 months after ablation. Eligible participants will be 18 to 80 years old, have a body mass index of at least 25 kg/m², and weigh more than 60 kg.
Participants will be randomly assigned to one of two groups. The first group will receive an initial shock of 150 joules, increased to 200 joules if needed. The second group will receive an initial shock based on body weight: 300 joules for participants weighing less than 90 kg and 360 joules for those weighing 90 kg or more. If the initial shock does not restore normal heart rhythm, further shocks will be delivered according to the study protocol.
The study will compare the proportion of participants in each group whose normal heart rhythm is restored shortly after cardioversion and whose rhythm remains stable. The study team will also record complications, changes in selected laboratory measures and quality of life, medication use, and treatment costs.
Detailed description
Electrical cardioversion is commonly used to restore normal heart rhythm in patients with atrial fibrillation. The energy level used during cardioversion may affect both the likelihood of restoring normal rhythm and the risk of complications. A lower initial energy may reduce exposure to high-energy shocks but may be less effective and require additional shocks. A higher initial energy selected according to body weight may improve cardioversion success, particularly in patients with higher body mass, but its effects on safety and other clinical outcomes require further evaluation.
This multicenter randomized study will compare a conventional step-up energy strategy with a body weight-based higher-energy strategy in patients with atrial fibrillation who are scheduled to undergo electrical cardioversion. The study will assess cardioversion success and maintenance of normal rhythm, as well as safety outcomes and other measures described in the study record. The results may help inform energy selection for cardioversion in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter, randomized, parallel-group study comparing conventional step-up energy cardioversion with body weight-based higher-energy cardioversion.
| Arm | Type | Receives |
|---|---|---|
| Conventional Step-Up Energy Group | Other | Other: Conventional Step-Up Energy CardioversionParticipants will undergo synchronized electrical cardioversion starting at 150 J. If the initial shock does not restore sinus rhythm, the energy will be increased to 200 J according to the study protocol. |
| Body Weight-Based Higher-Energy Group | Experimental | Other: Synchronized Electrical Cardioversion With Different Energy StrategiesParticipants will undergo synchronized electrical cardioversion using an initial energy selected according to body weight: 300 J for participants weighing less than 90 kg and 360 J for participants weighing 90 kg or more. If the initial shock does not restore sinus rhythm, further shocks will be delivered according to the study protocol. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of atrial fibrillation Age 18 to 80 years, inclusive.
Key exclusion criteria (1 listed)
- Severe cardiac disease, such as heart failure or valvular heart disease. Hemodynamically unstable atrial fibrillation. Severe hepatic or renal impairment. Unable to tolerate electrical cardioversion. Untreated hyperthyroidism. Pregnant. Previously enrolled in this study. Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.
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 |
|---|---|---|
| Synchronized Electrical Cardioversion With Different Energy StrategiesParticipants will undergo synchronized electrical cardioversion using a defibrillator monitor. The study compares two energy strategies: a conventional step-up strategy starting at 150 J and increasing to 200 J if needed, and a body weight-based strategy starting at 300 J for participants weighing less than 90 kg or 360 J for those weighing 90 kg or more. If the initial shock is unsuccessful, additional shocks will be delivered according to the study protocol. | Other | Body Weight-Based Higher-Energy Group |
| Conventional Step-Up Energy CardioversionParticipants will receive synchronized electrical cardioversion starting at 150 J. If unsuccessful, the energy will be increased to 200 J. | Other | Conventional Step-Up Energy Group |
Primary outcome
First-Shock Cardioversion Success Within 1 Minute
Time frame: Within 1 minute after the first shock
Proportion of participants who return to sinus rhythm within 1 minute after the first synchronized electrical shock.
Overall Cardioversion Success Within 1 Minute
Time frame: Within 1 minute after cardioversion
Proportion of participants who return to sinus rhythm within 1 minute after cardioversion, including any additional shocks given during the procedure.
First-Shock Cardioversion Success Maintained for at Least 30 Minutes
Time frame: From the first shock through at least 30 minutes after restoration of sinus rhythm
Proportion of participants who return to sinus rhythm after the first shock and maintain sinus rhythm for at least 30 minutes.
4 secondary outcomes
Change in Cardiac Injury Biomarkers
Time frame: Within 24 hours before and 24 hours after cardioversion
Change in Renal Function Measures
Time frame: Within 24 hours before and 24 hours after cardioversion
Cardioversion-Related Adverse Events
Time frame: During cardioversion through 24 hours after cardioversion; serious adverse events through 30 days
Skin Reaction at Electrode Sites
Time frame: 2 hours after cardioversion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Results publication: 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.
- Results publication: PubMed 31504412Schmidt AS, Lauridsen KG, Torp P, Bach LF, Rickers H, Lofgren B. Maximum-fixed energy shocks for cardioverting atrial fibrillation. Eur Heart J. 2020 Feb 1;41(5):626-631. doi: 10.1093/eurheartj/ehz585.
- Results publication: PubMed 36503970Nguyen ST, Belley-Cote EP, Ibrahim O, Um KJ, Lengyel A, Adli T, Qiu Y, Wong M, Sibilio S, Benz AP, Wolf A, Whitlock NJ, Gabriel Acosta J, Healey JS, Baranchuk A, McIntyre WF. Techniques improving electrical cardioversion success for patients with atrial fibrillation: a systematic review and meta-analysis. Europace. 2023 Feb 16;25(2):318-330. doi: 10.1093/europace/euac199.
- Individual participant dataSharing planned: No. Individual participant data collected in this study will not be shared with researchers outside the study team. Data sharing has not been approved under the current study protocol and data governance arrangements.
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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.
Ting Yin principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
Xiaoxiao Yin principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Synchronized Electrical Cardioversion With Different Energy Strategies and Conventional Step-Up Energy Cardioversion in people with Atrial Fibrillation (AF), run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jifang Cheng (13757118672, 2197018@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First-Shock Cardioversion Success Within 1 Minute (time frame: Within 1 minute after the first shock). The study lists 3 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 NCT07884253, which also lists 3 linked publications.
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 20 Oct 2026.