Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05903170




Registration number
NCT05903170
Ethics application status
Date submitted
25/05/2023
Date registered
15/06/2023
Date last updated
24/04/2024

Titles & IDs
Public title
Shock Energy for Electrical Cardioversion of Persistent Atrial Fibrillation
Scientific title
A Randomised Trial of Shock Energy for Electrical Cardioversion of Persistent Atrial Fibrillation
Secondary ID [1] 0 0
WRH DCCV
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - 360J LifePak Monitor/Defibrillator
Treatment: Devices - 200J Philips HeartStart MRx Monitor/Defibrillator

Active Comparator: 360J LifePak Monitor/Defibrillator - The standardised cardioversion protocol below performed with a 360J shock from a Lifepak Monitor/Defibrillator.
First shock with anteroposterior pad configuration
In event of failure of the above, a second shock with anterolateral pad configuration
In event of failure of the above, a third shock with anteroposterior pad configuration + manual pad pressure

Active Comparator: 200J Philips HeartStart MRx Monitor/Defibrillator - The standardised cardioversion protocol below performed with a 200J shock from a Philips HeartStart MRx Monitor/Defibrillator.
First shock with anteroposterior pad configuration
In event of failure of the above, a second shock with anterolateral pad configuration
In event of failure of the above, a third shock with anteroposterior pad configuration + manual pad pressure
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


Treatment: Devices: 360J LifePak Monitor/Defibrillator
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.

Treatment: Devices: 200J Philips HeartStart MRx Monitor/Defibrillator
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cardioversion efficacy
Timepoint [1] 0 0
During Procedure (1 Hour)
Secondary outcome [1] 0 0
Shock number
Timepoint [1] 0 0
During Procedure (1 Hour)
Secondary outcome [2] 0 0
Cumulative energy
Timepoint [2] 0 0
During Procedure (1 Hour)

Eligibility
Key inclusion criteria
- 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Contraindication to anticoagulation

- Atrial flutter

- Emergent cardioversion

- Implantable cardiac device (PPM or ICD)

- Unable to consent to cardioversion and/or study participation

- Pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/05/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2026
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Other
Name
Wellington Hospital
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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 .
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05903170
Trial related presentations / 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.
ECC 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.
Lippi 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. Erratum In: Int J Stroke. 2020 Jan 28;:1747493020905964.
Joglar 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.
Koster 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.
Page 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.
Schmidt 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.
Staerk 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.
Public notes

Contacts
Principal investigator
Name 0 0
Allan Plant, FRACP
Address 0 0
Wellington Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Allan M Plant, FRACP
Address 0 0
Country 0 0
Phone 0 0
+64274114001
Fax 0 0
Email 0 0
allanmplant@gmail.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05903170