Register a trial

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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] 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.

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] 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
NA
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] 0 0
New Zealand
State/province [1] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Government body
Name
Wellington Hospital
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
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
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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