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Trial details imported from ClinicalTrials.gov

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

Registration number

NCT05903170

Ethics application status

Date submitted

25/05/2023

Date registered

15/06/2023

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]

WRH DCCV

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Atrial Fibrillation

Condition category

Condition code

Cardiovascular

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.

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

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.

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

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]

Treatment: Devices

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Cardioversion efficacy

Timepoint [1]

During Procedure (1 Hour)

Secondary outcome [1]

Shock number

Timepoint [1]

During Procedure (1 Hour)

Secondary outcome [2]

Cumulative energy

Timepoint [2]

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?

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

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

1/08/2024

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]

New Zealand

State/province [1]

Wellington

Funding & Sponsors

Primary sponsor type

Government body

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/study/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 Dec;15(9):NP11-NP12. doi: 10.1177/1747493020905964.
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

Allan Plant, FRACP

Address

Wellington Hospital

Country

Phone

Fax

Contact person for public queries

Name

Allan M Plant, FRACP

Address

Country

Phone

+64274114001

Fax

[email protected]

Contact person for scientific queries

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05903170

Register a trial

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