Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001028998
Ethics application status
Approved
Date submitted
12/08/2020
Date registered
9/10/2020
Date last updated
3/04/2024
Date data sharing statement initially provided
9/10/2020
Date results information initially provided
3/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Chest Pressure for Electrical Cardioversion in Atrial Fibrillation.
Scientific title
Investigating the Efficacy of Chest Pressure for Direct Current Cardioversion in Atrial Fibrillation: A Randomised Control Trial (Pressure-AF)
Secondary ID [1] 302011 0
None
Universal Trial Number (UTN)
U1111-1256-6997
Trial acronym
PRESSURE-AF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 318571 0
Condition category
Condition code
Cardiovascular 316586 316586 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised in a 1 to 1 ratio to an initial strategy of chest pressure with direct current cardioversion (intervention) or a strategy of chest pressure only if refractory to direct current cardioversion without pressure (control). Direct current cardioversion pads will be placed in an anterior-posterior position.

The intervention strategy will consist of up to four attempts of direct current cardioversion with increasing energy administered as follows:
- 1 shock – 150 Joules with chest pressure
- 1 shock – 200 Joules with chest pressure
- 2 shocks – 360 Joules with chest pressure
Manual chest pressure will be applied with gloves and a towel by the proceduralist (cardiologist/cardiology trainee) over the anterior pad. A maximum of four shocks will be provided until cardioversion success or failure, with a maximum energy of 360 Joules.

Follow-up will be until hospital discharge, on the day of outpatient cardioversion. Data will be collected at the time of cardioversion by the proceduralist. Adherence to the study design and protocol will be monitored through review of the medical notes.
Intervention code [1] 318300 0
Treatment: Other
Comparator / control treatment
Up to four attempts at electrical cardioversion with increasing energy, with chest pressure applied only on the last shock.
- 1 shock – 150 Joules without chest pressure
- 1 shock – 200 Joules without chest pressure
- 1 shock – 360 Joules without chest pressure
- 1 shock – 360 Joules with chest pressure
A maximum/total of four shocks will be provided until success or failure, with a maximum energy of 360 joules.
Control group
Active

Outcomes
Primary outcome [1] 324718 0
Total joules per encounter.
Documented by the proceduralist performing cardioversion.
Timepoint [1] 324718 0
On the day of cardioversion.
Secondary outcome [1] 385521 0
Success of first shock for reversion to sinus rhythm.
Determined by defibrillator telemetry recording.
Timepoint [1] 385521 0
On the day of cardioversion.
Secondary outcome [2] 385522 0
Transthoracic impedance at the time of shock.
Provided by the defibrillator report printed at the time of cardioversion.

Timepoint [2] 385522 0
On the day of cardioversion.
Secondary outcome [3] 386835 0
Chest pain 30 minutes post cardioversion
Ordinal scale 0-10
Measured through patient questioning by medical staff
Timepoint [3] 386835 0
30 minutes post cardioversion
Secondary outcome [4] 386836 0
Shock sustained by proceduralist.
Documented by the proceduralist at the time of cardioversion.
Timepoint [4] 386836 0
At the time of cardioversion.

Eligibility
Key inclusion criteria
Has atrial fibrillation
Age 18 or older
Referred for direct current cardioversion
Three weeks of therapeutic anti-coagulation prior to cardioversion or trans-oesophageal echocardiography to exclude left atrial appendage thrombus.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy or Breastfeeding
Inability to provide informed consent
Other atrial tachyarrhythmias (atrial flutter of multifocal atrial tachycardia)
Medical comorbidity where anticoagulation is contra-indicated

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2020
Actual
19/04/2021
Date of last participant enrolment
Anticipated
1/12/2023
Actual
25/08/2023
Date of last data collection
Anticipated
31/12/2023
Actual
8/09/2023
Sample size
Target
308
Accrual to date
Final
311
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 306432 0
Hospital
Name [1] 306432 0
Cardiovascular Department, John Hunter Hospital
Country [1] 306432 0
Australia
Primary sponsor type
Hospital
Name
Cardiovascular Department, John Hunter Hospital
Address
Lookout Road, New Lambton Heights, Newcastle, NSW 2305
Country
Australia
Secondary sponsor category [1] 306946 0
Hospital
Name [1] 306946 0
Cardiovascular Department, Gosford Hospital
Address [1] 306946 0
Holden St, Gosford NSW 2250
Country [1] 306946 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306639 0
Hunter New England Research Ethics Committee
Ethics committee address [1] 306639 0
Level 3, Pod, HMRI, Lot 1, Kookaburra Circuit, New Lambton Heights NSW 2305
Ethics committee country [1] 306639 0
Australia
Date submitted for ethics approval [1] 306639 0
28/08/2020
Approval date [1] 306639 0
18/02/2021
Ethics approval number [1] 306639 0

Summary
Brief summary
Chest pressure during direct current cardioversion reduces transthoracic resistance and increases cardiac energy delivery. This may decrease energy requirements, potentially increasing cardioversion success and reducing procedure time. The purpose of this study is to examine the efficacy of an initial strategy of chest pressure for direct current cardioversion for atrial fibrillation. Those enrolled will be randomised in a 1 to 1 ratio to the control or intervention arm.

The intervention strategy will consist of up to three attempts of direct current cardioversion with chest pressure with increasing energy administered as follows:
- 1 shock – 150 Joules with chest pressure
- 1 shock – 200 Joules with chest pressure
- 2 shocks – 360 Joules with chest pressure
Manual chest pressure will be applied with gloves and a towel by the proceduralist (cardiologist/cardiology trainee) over the anterior pad. A maximum of four shocks will be provided until cardioversion success or failure, with a maximum energy of 360 Joules.

The control strategy will consist of up to three attempts of direct current cardioversion with increasing energy administered as follows:
- 1 shock – 150 Joules without chest pressure
- 1 shock – 200 Joules without chest pressure
- 1 shock - 360 Joules without chest pressure
- 1 shock – 360 Joules with chest pressure
A maximum of four shocks will be provided until cardioversion success or failure, with a maximum energy of 360 Joules.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104518 0
Dr David Ferreira
Address 104518 0
Cardiovascular Department, John Hunter Hospital
Lookout Road, New Lambton Heights, Newcastle, NSW 2305
Country 104518 0
Australia
Phone 104518 0
+61 0433870118
Fax 104518 0
Email 104518 0
[email protected]
Contact person for public queries
Name 104519 0
Dr David Ferreira
Address 104519 0
Cardiovascular Department, John Hunter Hospital
Lookout Road, New Lambton Heights, Newcastle, NSW 2305
Country 104519 0
Australia
Phone 104519 0
+61 0433870118
Fax 104519 0
Email 104519 0
[email protected]
Contact person for scientific queries
Name 104520 0
Dr David Ferreira
Address 104520 0
Cardiovascular Department, John Hunter Hospital
Lookout Road, New Lambton Heights, Newcastle, NSW 2305
Country 104520 0
Australia
Phone 104520 0
+61 0433870118
Fax 104520 0
Email 104520 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual patient data collected during the trial.
When will data be available (start and end dates)?
Following publication. No end date.
Available to whom?
For researchers who provide methodologically sound proposals.
Available for what types of analyses?
Case by case basis dependent on aim and design of the analysis.
How or where can data be obtained?
Contacting the Principle Investigators.
[email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8772Study protocol  [email protected]
8773Informed consent form  [email protected]
8775Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseInvestigating the efficacy of chest pressure for direct current cardioversion in atrial fibrillation: A randomised control trial protocol (Pressure-AF).2021https://dx.doi.org/10.1136/openhrt-2021-001739
N.B. These documents automatically identified may not have been verified by the study sponsor.