Atrial FibrillationNCT05903170
Shock Energy for Electrical Cardioversion of Persistent Atrial Fibrillation
A study testing 360J LifePak Monitor/Defibrillator and 200J Philips HeartStart MRx Monitor/Defibrillator in people with Atrial Fibrillation, run by Wellington Hospital at 1 site in New Zealand.
Trial summary
The goal of this clinical trial is to compare the efficacy of a maximum output shock for cardioverting atrial fibrillation between two commonly used defibrillators in New Zealand . 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?
- 360J LifePak Monitor/Defibrillator and 200J Philips HeartStart MRx Monitor/Defibrillator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNew Zealand
- Study dates
- Aug 2025to Aug 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18
- Patients undergoing either elective outpatient or non-emergent inpatient cardioversion for atrial fibrillation
- Eligible for anticoagulation
- Reliably anticoagulated for ≥three weeks prior to cardioversion, AF onset within 48hrs of cardioversion, or left atrial thrombus excluded on transoesophageal echocardiogram
- Able to consent to cardioversion, and study participation
Who cannot join
- Contraindication to anticoagulation
- Atrial flutter
- Emergent cardioversion
- Implantable cardiac device (PPM or ICD)
- Unable to consent to cardioversion and/or study participation
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Darren Hooks, FRACP contact
New Zealand1 site, 1 recruiting
- Recruiting
Wellington Regional Hospital
Wellington, Wellington Region, 6012
Allan Plant, MBChB, 0274114001, allanmplant@gmail.com
Darren Hooks, MBChB, PhD, darren.hooks@ccdhb.org.nz
About this study
Official title: A Randomised Trial of Shock Energy for Electrical Cardioversion of Persistent Atrial Fibrillation
The goal of this clinical trial is to compare the efficacy of a maximum output shock for cardioverting atrial fibrillation between two commonly used defibrillators in New Zealand . These machines have different maximum energy outputs, and to date no head-to-head comparison cardioverting atrial fibrillation between the two has been undertaken.
The main question it aims to answer is whether either device is more likely to cardiovert patients referred for atrial fibrillation.
Read more
Participants will be randomized to undergo cardioversion with one of two defibrillators at either 200J or 360J. Participants in each arm will undergo up to three shocks at the energy-level to which they have been randomized, using a standardized procedure. For participants randomized to the lower energy level who fail to return to normal rhythm after three shocks, they will be given a fourth shock at the higher energy level.
All participants will then be asked to undertake a blood test the day following the cardioversion, and receive a follow up phone call. These are to ensure there is no difference in the safety of the procedure between the two energy levels. It is worth noting that these two components of the study (the blood test and phone call) are the only additional time commitment that is expected to be involved if you choose to participate in the study.
Read the detailed description
Atrial fibrillation is the world's most common arrhythmia, with an incidence that is increasing in Western countries. One-in-four adults will experience atrial fibrillation at some point in their life.
Strategies for the management of atrial fibrillation include rate control, prophylaxis against stroke, lifestyle modification, and restoration of sinus rhythm through medical or electrical cardioversion. Electrical cardioversion for the restoration of sinus rhythm was first described by Lown and colleagues in 1962, and has undergone a number of procedural advances in the intervening six decades. Chief amongst these was a transition from cardioverting using monophasic to biphasic waveforms, something unequivocally demonstrated to increase cardioversion success, with lower energy, current, and less skin and muscle damage than monophasic devices. Yet the majority of the data which continues to guide cardioversion is derived from the era of monophasic therapy.
Data from cardioversion with monophasic waveforms suggests that the use of higher initial shock energy is associated with higher first shock success, fewer shocks, and lower levels of skeletal muscle injury, with no increase in troponin to suggest greater cardiac injury. Likewise, studies of shock energy using biphasic devices have demonstrated benefit of maximum fixed shock energy. However, whilst the energy of a defibrillator remains entrenched in the descriptive vocabulary of cardioversion for atrial fibrillation, it is the flow of current across the myocardium that achieves cardioversion, and resuscitation guidelines have previously recommended a switch to the more physiologic current-based description.
Different defibrillators deliver different currents at the same energy setting based on the capacitance of the device. As such, manufacturers of defibrillators recommend different energy levels for cardioverting atrial fibrillation with some standard biphasic defibrillators (Philips HeartStart MRx Monitor/Defibrillator) unable to deliver higher than 200J energy, while some (Lifepak 15 Monitor/Defibrillator) extend to 360J. No studies have compared initial 200J vs. 360J shock energies between these devices for cardioverting persistent atrial fibrillation.
This study is a single centre randomized non-blinded study of the effectiveness of 200J vs. 360J fixed output biphasic electrical cardioversion in patients undergoing electrical cardioversion of persistent atrial fibrillation. The study hypothesis is that cardioversion with shock energy fixed to 360J delivered by a LifePak Monitor/Defibrillator is more efficacious than a 200J delivered by a Philips HeartStart MRx Monitor/Defibrillator, without worsening safety outcomes.
- Conditions
- Atrial Fibrillation
- Being tested
- 360J LifePak Monitor/Defibrillator, 200J Philips HeartStart MRx Monitor/Defibrillator
- Keywords
- Atrial fibrillation, Electrical cardioversion
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
360J LifePak Monitor/DefibrillatorDevice
The LifePak Monitor/Defibrillator is a commonly-used defibrillator in New Zealand hospitals for cardioverting atrial fibrillation. It delivers a biphasic waveform shock with a titratable maximum energy of 360J.
200J Philips HeartStart MRx Monitor/DefibrillatorDevice
The Philips HeartStart MRx Monitor/Defibrillator is a commonly-used defibrillator in New Zealand hospitals for cardioverting atrial fibrillation. It delivers a biphasic waveform shock with a titratable maximum energy of 200J.
| Study group | Role | What they receive |
|---|---|---|
| 360J LifePak Monitor/Defibrillator | Active comparator | The standardised cardioversion protocol below performed with a 360J shock from a Lifepak Monitor/Defibrillator.
1. First shock with anteroposterior pad configuration
2. In event of failure of the above, a second shock with anterolateral pad configuration
3. In event of failure of the above, a third shock with anteroposterior pad configuration + manual pad pressure Receives: Device: 360J LifePak Monitor/Defibrillator |
| 200J Philips HeartStart MRx Monitor/Defibrillator | Active comparator | The standardised cardioversion protocol below performed with a 200J shock from a Philips HeartStart MRx Monitor/Defibrillator.
1. First shock with anteroposterior pad configuration
2. In event of failure of the above, a second shock with anterolateral pad configuration
3. In event of failure of the above, a third shock with anteroposterior pad configuration + manual pad pressure
4. The addition of a fourth 'rescue' shock at 360J using the LifePak Monitor/Defibrillator with pads in the anteroposterior configuration in the event of the first three steps failing to cardiovert to sinus rhythm Receives: Device: 200J Philips HeartStart MRx Monitor/Defibrillator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardioversion efficacy
Percentage of patients successfully cardioverted to sinus rhythm
Measured: During Procedure (1 Hour)
Secondary outcomes (2)
Shock number
Number of shocks required to cardiovert to sinus rhythm
Measured: During Procedure (1 Hour)
Cumulative energy
Total energy delivered during procedure
Measured: During Procedure (1 Hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study startAug 2025 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- Model description
- Participants will be randomized to undergo cardioversion with one of two defibrillators at either 200J or 360J. Randomization will occur by a random number generator, and the chance of being in either arm is 50%. Participants in each arm will undergo up to three shocks at the energy-level to which they have been randomized, using a standardized procedure. For participants randomized to the lower energy level who fail to return to normal rhythm after three shocks, they will be given a fourth shock at the higher energy level.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wellington Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Allan Plant, Wellington Hospital
- Investigators
- Allan Plant, FRACP, Principal investigator, Wellington Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05903170
- Sponsor's protocol ID
- WRH DCCV
- Status last verified
- Mar 2025
- First submitted
- 25 May 2023
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boos C, Thomas MD, Jones A, Clarke E, Wilbourne G, More RS. Higher energy monophasic DC cardioversion for persistent atrial fibrillation: is it time to start at 360 joules? Ann Noninvasive Electrocardiol. 2003 Apr;8(2):121-6. doi: 10.1046/j.1542-474x.2003.08205.x.
PubMed 12848792ECC Committee, Subcommittees and Task Forces of the American Heart Association. 2005 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2005 Dec 13;112(24 Suppl):IV1-203. doi: 10.1161/CIRCULATIONAHA.105.166550. Epub 2005 Nov 28. No abstract available.
PubMed 16314375Lippi G, Sanchis-Gomar F, Cervellin G. Global epidemiology of atrial fibrillation: An increasing epidemic and public health challenge. Int J Stroke. 2021 Feb;16(2):217-221. doi: 10.1177/1747493019897870. Epub 2020 Jan 19.
PubMed 31955707Joglar JA, Hamdan MH, Ramaswamy K, Zagrodzky JD, Sheehan CJ, Nelson LL, Andrews TC, Page RL. Initial energy for elective external cardioversion of persistent atrial fibrillation. Am J Cardiol. 2000 Aug 1;86(3):348-50. doi: 10.1016/s0002-9149(00)00932-2.
PubMed 10922451Koster RW, Dorian P, Chapman FW, Schmitt PW, O'Grady SG, Walker RG. A randomized trial comparing monophasic and biphasic waveform shocks for external cardioversion of atrial fibrillation. Am Heart J. 2004 May;147(5):e20. doi: 10.1016/j.ahj.2003.10.049.
PubMed 15131555Page RL, Kerber RE, Russell JK, Trouton T, Waktare J, Gallik D, Olgin JE, Ricard P, Dalzell GW, Reddy R, Lazzara R, Lee K, Carlson M, Halperin B, Bardy GH; BiCard Investigators. Biphasic versus monophasic shock waveform for conversion of atrial fibrillation: the results of an international randomized, double-blind multicenter trial. J Am Coll Cardiol. 2002 Jun 19;39(12):1956-63. doi: 10.1016/s0735-1097(02)01898-3.
PubMed 12084594Schmidt 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 31504412Staerk L, Wang B, Preis SR, Larson MG, Lubitz SA, Ellinor PT, McManus DD, Ko D, Weng LC, Lunetta KL, Frost L, Benjamin EJ, Trinquart L. Lifetime risk of atrial fibrillation according to optimal, borderline, or elevated levels of risk factors: cohort study based on longitudinal data from the Framingham Heart Study. BMJ. 2018 Apr 26;361:k1453. doi: 10.1136/bmj.k1453.
PubMed 29699974
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Trial of Shock Energy for Electrical Cardioversion of Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT05903170
- Acronym / sponsor ID
- WRH DCCV
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Electrical cardioversion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wellington HospitalOther government
- Study start
- Aug 2025 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 15 Jun 2023 (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.
The goal of this clinical trial is to compare the efficacy of a maximum output shock for cardioverting atrial fibrillation between two commonly used defibrillators in New Zealand . These machines have different maximum energy outputs, and to date no head-to-head comparison cardioverting atrial fibrillation between the two has been undertaken.
The main question it aims to answer is whether either device is more likely to cardiovert patients referred for atrial fibrillation.
Participants will be randomized to undergo cardioversion with one of two defibrillators at either 200J or 360J. Participants in each arm will undergo up to three shocks at the energy-level to which they have been randomized, using a standardized procedure. For participants randomized to the lower energy level who fail to return to normal rhythm after three shocks, they will be given a fourth shock at the higher energy level.
All participants will then be asked to undertake a blood test the day following the cardioversion, and receive a follow up phone call. These are to ensure there is no difference in the safety of the procedure between the two energy levels. It is worth noting that these two components of the study (the blood test and phone call) are the only additional time commitment that is expected to be involved if you choose to participate in the study.
Detailed description
Atrial fibrillation is the world's most common arrhythmia, with an incidence that is increasing in Western countries. One-in-four adults will experience atrial fibrillation at some point in their life.
Strategies for the management of atrial fibrillation include rate control, prophylaxis against stroke, lifestyle modification, and restoration of sinus rhythm through medical or electrical cardioversion. Electrical cardioversion for the restoration of sinus rhythm was first described by Lown and colleagues in 1962, and has undergone a number of procedural advances in the intervening six decades. Chief amongst these was a transition from cardioverting using monophasic to biphasic waveforms, something unequivocally demonstrated to increase cardioversion success, with lower energy, current, and less skin and muscle damage than monophasic devices. Yet the majority of the data which continues to guide cardioversion is derived from the era of monophasic therapy.
Data from cardioversion with monophasic waveforms suggests that the use of higher initial shock energy is associated with higher first shock success, fewer shocks, and lower levels of skeletal muscle injury, with no increase in troponin to suggest greater cardiac injury. Likewise, studies of shock energy using biphasic devices have demonstrated benefit of maximum fixed shock energy. However, whilst the energy of a defibrillator remains entrenched in the descriptive vocabulary of cardioversion for atrial fibrillation, it is the flow of current across the myocardium that achieves cardioversion, and resuscitation guidelines have previously recommended a switch to the more physiologic current-based description.
Different defibrillators deliver different currents at the same energy setting based on the capacitance of the device. As such, manufacturers of defibrillators recommend different energy levels for cardioverting atrial fibrillation with some standard biphasic defibrillators (Philips HeartStart MRx Monitor/Defibrillator) unable to deliver higher than 200J energy, while some (Lifepak 15 Monitor/Defibrillator) extend to 360J. No studies have compared initial 200J vs. 360J shock energies between these devices for cardioverting persistent atrial fibrillation.
This study is a single centre randomized non-blinded study of the effectiveness of 200J vs. 360J fixed output biphasic electrical cardioversion in patients undergoing electrical cardioversion of persistent atrial fibrillation. The study hypothesis is that cardioversion with shock energy fixed to 360J delivered by a LifePak Monitor/Defibrillator is more efficacious than a 200J delivered by a Philips HeartStart MRx Monitor/Defibrillator, without worsening safety outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to undergo cardioversion with one of two defibrillators at either 200J or 360J. Randomization will occur by a random number generator, and the chance of being in either arm is 50%. Participants in each arm will undergo up to three shocks at the energy-level to which they have been randomized, using a standardized procedure. For participants randomized to the lower energy level who fail to return to normal rhythm after three shocks, they will be given a fourth shock at the higher energy level.
| Arm | Type | Receives |
|---|---|---|
| 360J LifePak Monitor/Defibrillator | Active comparator | Device: 360J LifePak Monitor/DefibrillatorThe standardised cardioversion protocol below performed with a 360J shock from a Lifepak Monitor/Defibrillator. 1. First shock with anteroposterior pad configuration 2. In event of failure of the above, a second shock with anterolateral pad configuration 3. In event of failure of the above, a third shock with anteroposterior pad configuration + manual pad pressure |
| 200J Philips HeartStart MRx Monitor/Defibrillator | Active comparator | Device: 200J Philips HeartStart MRx Monitor/DefibrillatorThe standardised cardioversion protocol below performed with a 200J shock from a Philips HeartStart MRx Monitor/Defibrillator. 1. First shock with anteroposterior pad configuration 2. In event of failure of the above, a second shock with anterolateral pad configuration 3. In event of failure of the above, a third shock with anteroposterior pad configuration + manual pad pressure 4. The addition of a fourth 'rescue' shock at 360J using the LifePak Monitor/Defibrillator with pads in the anteroposterior configuration in the event of the first three steps failing to cardiovert to sinus rhythm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >18
- Patients undergoing either elective outpatient or non-emergent inpatient cardioversion for atrial fibrillation
- Eligible for anticoagulation
- Reliably anticoagulated for ≥three weeks prior to cardioversion, AF onset within 48hrs of cardioversion, or left atrial thrombus excluded on transoesophageal echocardiogram
- Able to consent to cardioversion, and study participation
Key exclusion criteria (6 listed)
- Contraindication to anticoagulation
- Atrial flutter
- Emergent cardioversion
- Implantable cardiac device (PPM or ICD)
- Unable to consent to cardioversion and/or study participation
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 |
|---|---|---|
| 360J LifePak Monitor/DefibrillatorThe LifePak Monitor/Defibrillator is a commonly-used defibrillator in New Zealand hospitals for cardioverting atrial fibrillation. It delivers a biphasic waveform shock with a titratable maximum energy of 360J. | Device | 360J LifePak Monitor/Defibrillator |
| 200J Philips HeartStart MRx Monitor/DefibrillatorThe Philips HeartStart MRx Monitor/Defibrillator is a commonly-used defibrillator in New Zealand hospitals for cardioverting atrial fibrillation. It delivers a biphasic waveform shock with a titratable maximum energy of 200J. | Device | 200J Philips HeartStart MRx Monitor/Defibrillator |
Primary outcome
Cardioversion efficacy
Time frame: During Procedure (1 Hour)
Percentage of patients successfully cardioverted to sinus rhythm
2 secondary outcomes
Shock number
Time frame: During Procedure (1 Hour)
Cumulative energy
Time frame: During Procedure (1 Hour)
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 1 Apr 2025.
- Background: PubMed 12848792Boos C, Thomas MD, Jones A, Clarke E, Wilbourne G, More RS. Higher energy monophasic DC cardioversion for persistent atrial fibrillation: is it time to start at 360 joules? Ann Noninvasive Electrocardiol. 2003 Apr;8(2):121-6. doi: 10.1046/j.1542-474x.2003.08205.x.
- Background: PubMed 16314375ECC Committee, Subcommittees and Task Forces of the American Heart Association. 2005 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2005 Dec 13;112(24 Suppl):IV1-203. doi: 10.1161/CIRCULATIONAHA.105.166550. Epub 2005 Nov 28. No abstract available.
- Background: PubMed 31955707Lippi G, Sanchis-Gomar F, Cervellin G. Global epidemiology of atrial fibrillation: An increasing epidemic and public health challenge. Int J Stroke. 2021 Feb;16(2):217-221. doi: 10.1177/1747493019897870. Epub 2020 Jan 19.
- Background: PubMed 10922451Joglar JA, Hamdan MH, Ramaswamy K, Zagrodzky JD, Sheehan CJ, Nelson LL, Andrews TC, Page RL. Initial energy for elective external cardioversion of persistent atrial fibrillation. Am J Cardiol. 2000 Aug 1;86(3):348-50. doi: 10.1016/s0002-9149(00)00932-2.
- Background: PubMed 15131555Koster RW, Dorian P, Chapman FW, Schmitt PW, O'Grady SG, Walker RG. A randomized trial comparing monophasic and biphasic waveform shocks for external cardioversion of atrial fibrillation. Am Heart J. 2004 May;147(5):e20. doi: 10.1016/j.ahj.2003.10.049.
- Background: PubMed 12084594Page RL, Kerber RE, Russell JK, Trouton T, Waktare J, Gallik D, Olgin JE, Ricard P, Dalzell GW, Reddy R, Lazzara R, Lee K, Carlson M, Halperin B, Bardy GH; BiCard Investigators. Biphasic versus monophasic shock waveform for conversion of atrial fibrillation: the results of an international randomized, double-blind multicenter trial. J Am Coll Cardiol. 2002 Jun 19;39(12):1956-63. doi: 10.1016/s0735-1097(02)01898-3.
- Background: 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.
- Background: PubMed 29699974Staerk L, Wang B, Preis SR, Larson MG, Lubitz SA, Ellinor PT, McManus DD, Ko D, Weng LC, Lunetta KL, Frost L, Benjamin EJ, Trinquart L. Lifetime risk of atrial fibrillation according to optimal, borderline, or elevated levels of risk factors: cohort study based on longitudinal data from the Framingham Heart Study. BMJ. 2018 Apr 26;361:k1453. doi: 10.1136/bmj.k1453.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
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.
Darren Hooks, FRACP contact
Allan Plant, FRACP principal investigator
Wellington Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 360J LifePak Monitor/Defibrillator and 200J Philips HeartStart MRx Monitor/Defibrillator in people with Atrial Fibrillation, run by Wellington Hospital at 1 site in New Zealand.
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 6 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: looking for participants now, as of the sponsor's last update on 1 Apr 2025. 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 New Zealand. 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?
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 Allan M Plant, FRACP (+64274114001, allanmplant@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardioversion efficacy (time frame: During Procedure (1 Hour)). 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 NCT05903170, which also lists 8 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 1 Apr 2025.