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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] 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
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
1/08/2024
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
allanmplant@gmail.com
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