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Trial registered on ANZCTR


Registration number
ACTRN12616000302459
Ethics application status
Approved
Date submitted
2/03/2016
Date registered
8/03/2016
Date last updated
4/03/2019
Date data sharing statement initially provided
4/03/2019
Date results provided
4/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating success rates of direct cardioversion for atrial fibrillation in patients with an elevated body mass index: a randomised controlled trial of adhesive patches vs hand-held paddles (DCR-BMI)
Scientific title
Evaluating success rates of direct cardioversion for atrial fibrillation in patients with an elevated body mass index: a randomised controlled trial of adhesive patches vs hand-held paddles (DCR-BMI)
Secondary ID [1] 288672 0
Nil known
Universal Trial Number (UTN)
U1111-1180-2525
Trial acronym
DCR-BMI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial fibrillation 297867 0
Obesity 297868 0
Condition category
Condition code
Cardiovascular 298042 298042 0 0
Other cardiovascular diseases
Diet and Nutrition 298043 298043 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Paddle arms (synchronised cardioversion for atrial fibrillation), delivered by medical practitioner. There will be 2 paddle groups (split up by position of paddle ie. shock vector) with an equal chance of being in either group.

Group 1 (Paddle - antero-apical position with patient supine)
1st shock: 100J via hand-held paddle (antero-apical position).
2nd shock (3 minutes later if 1st shock fails): 200J via hand-held paddle (antero-apical position).
3rd shock (3 minutes later if 2nd shock fails): 200J via self-adhesive patch (antero-apical position).

Additional shocks (up to 360J biphasic) may be delivered at the discretion of the treating clinician.

Group 2 (Paddle - antero-posterior position with patient on their side)
1st shock: 100J via hand-held paddle (antero-posterior).
2nd shock (3 minutes later if 1st shock fails): 200J via hand-held paddle (antero-posterior).
3rd shock (3 minutes later if 2nd shock fails): 200J via self-adhesive patch (antero-posterior).

Additional shocks (up to 360J biphasic) may be delivered at the discretion of the treating clinician.
Intervention code [1] 294091 0
Treatment: Other
Intervention code [2] 294114 0
Treatment: Devices
Comparator / control treatment
Patch arms (synchronised cardioversion for atrial fibrillation), delivered by medical practitioner. There will be 2 patch groups (split up by position of patch ie. shock vector) with an equal chance of being in either group.

Group 3 (Patch - antero-apical position with patient supine)
1st shock: 100J via self-adhesive patch (antero-apical position).
2nd shock (3 minutes later if 1st shock fails): 200J via self-adhesive patch (antero-apical position).
3rd shock (3 minutes later if 2nd shock fails): 200J via hand-held paddle (antero-apical position).

Additional shocks (up to 360J biphasic) may be delivered at the discretion of the treating clinician.

Group 4 (Patch - antero-posterior position with patient on their side)
1st shock: 100J via self-adhesive patch (antero-posterior).
2nd shock (3 minutes later if 1st shock fails): 200J via self-adhesive patch (antero-posterior).
3rd shock (3 minutes later if 2nd shock fails): 200J via hand-held paddle (antero-posterior).

Additional shocks (up to 360J biphasic) may be delivered at the discretion of the treating clinician.
Control group
Active

Outcomes
Primary outcome [1] 297556 0
Rate of successful cardioversion (either 1st or 2nd shock) - as determined by rhythm strip or ECG during the procedure.
Timepoint [1] 297556 0
On day of cardioversion
Primary outcome [2] 297557 0
Rate of successful cardioversion by modality (ie. patch or paddle) - as determined by rhythm strip or ECG during the procedure.
Timepoint [2] 297557 0
On day of cardioversion
Secondary outcome [1] 321400 0
Rate of successful cardioversion with 1st shock - as determined by rhythm strip or ECG during the procedure.
Timepoint [1] 321400 0
On day of cardioversion
Secondary outcome [2] 321401 0
Rate of successful cardioversion (either 3 shocks) per patient - as determined by rhythm strip or ECG during the procedure.
Timepoint [2] 321401 0
On day of cardioversion
Secondary outcome [3] 321402 0
Presence of sinus rhythm at end of procedure (by ECG).
Timepoint [3] 321402 0
On day of cardioversion
Secondary outcome [4] 321403 0
Cumulative energy use (Joules) - assessed by adding total amount of energy used for all shocks per patient.
Timepoint [4] 321403 0
On day of cardioversion
Secondary outcome [5] 321404 0
Maintenance of sinus rhythm at 3 months (by ECG at 3 months and/or review of ECGs and symptoms within 3 months from cardioversion).
Timepoint [5] 321404 0
At 3 months from cardioversion

Eligibility
Key inclusion criteria
- Clinical indication for cardioversion of atrial fibrillation and/or atrial flutter.
- Body Mass Index at least 30.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Critically-ill patients
- Inability to provide informed consent

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)
Patients will be randomised in a 1:1:1:1 fashion at each hospital to either the ‘Patch’ arms (anteroposterior or anteroapical) or ‘Paddle’ arms (anteroposterior or anteroapical). This will be done by central randomisation by computer (hence 50% of patients will be randomised to a Paddle arm & 50% to a patch arm).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will also be stratified with respect to those with a BMI of at least 35 (i.e. randomised in a 1:1 fashion). This will be done by central randomisation by computer.
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
To detect a minimum absolute difference in the primary endpoint of 20% between both groups, we will need to enroll 58 patients in each group to provide a power of 0.8 at an alpha value of 0.05

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/07/2016
Actual
29/07/2016
Date of last participant enrolment
Anticipated
2/07/2018
Actual
15/03/2018
Date of last data collection
Anticipated
15/06/2018
Actual
15/06/2018
Sample size
Target
116
Accrual to date
Final
125
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5369 0
The Alfred - Prahran
Recruitment hospital [2] 5370 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [3] 5371 0
Cabrini Hospital - Prahran - Prahran East
Recruitment hospital [4] 5372 0
Melbourne Private Hospital - Parkville
Recruitment hospital [5] 5373 0
Western Hospital - Footscray
Recruitment hospital [6] 5374 0
Sunshine Hospital - St Albans
Recruitment hospital [7] 5375 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 12824 0
3181 - Prahran
Recruitment postcode(s) [2] 12825 0
3144 - Malvern
Recruitment postcode(s) [3] 12826 0
3052 - Parkville
Recruitment postcode(s) [4] 12827 0
3011 - Footscray
Recruitment postcode(s) [5] 12828 0
3021 - St Albans
Recruitment postcode(s) [6] 12846 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 293029 0
Self funded/Unfunded
Name [1] 293029 0
Prof Peter Kistler
Country [1] 293029 0
Australia
Funding source category [2] 293050 0
Hospital
Name [2] 293050 0
Alfred Hospital
Country [2] 293050 0
Australia
Primary sponsor type
Individual
Name
Professor Peter Kistler
Address
Heart Centre,
Alfred Hospital,
Commercial Rd, Prahran, Vic, 3185
Country
Australia
Secondary sponsor category [1] 291804 0
Individual
Name [1] 291804 0
Dr Aleksandr Voskoboinik
Address [1] 291804 0
Heart Centre, Alfred Hospital, Commercial Rd, Prahran, Vic, 3181
Country [1] 291804 0
Australia
Other collaborator category [1] 278859 0
Individual
Name [1] 278859 0
Prof Jonathan Kalman
Address [1] 278859 0
Department of Cardiology, Royal Melbourne Hospital, Grattan St, Parkville, Vic, 3052
Country [1] 278859 0
Australia
Other collaborator category [2] 278860 0
Individual
Name [2] 278860 0
Dr Michael Wong
Address [2] 278860 0
Department of Cardiology, Western Hospital, Gordon St, Footscray, Vic, 3011
Country [2] 278860 0
Australia
Other collaborator category [3] 278861 0
Individual
Name [3] 278861 0
Dr Emily Kotschet
Address [3] 278861 0
Department of Cardiology, Monash Medical Centre, Clayton Rd, Clayton, Vic, 3168
Country [3] 278861 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294539 0
Alfred Health Human Research Ethics Committee
Ethics committee address [1] 294539 0
Ethics committee country [1] 294539 0
Australia
Date submitted for ethics approval [1] 294539 0
27/01/2016
Approval date [1] 294539 0
02/03/2016
Ethics approval number [1] 294539 0
HREC/16/Alfred/4

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64066 0
Prof Peter Kistler
Address 64066 0
Heart Centre, Alfred Hospital, Commercial Rd, Prahran, Vic, 3181
Country 64066 0
Australia
Phone 64066 0
+61 3 90766525
Fax 64066 0
+61 3 9076 2461
Email 64066 0
[email protected]
Contact person for public queries
Name 64067 0
Aleksandr Voskoboinik
Address 64067 0
Heart Centre, Alfred Hospital, Commercial Rd, Prahran, Vic, 3181
Country 64067 0
Australia
Phone 64067 0
+61 3 90762000
Fax 64067 0
+61 3 80800747
Email 64067 0
[email protected]
Contact person for scientific queries
Name 64068 0
Aleksandr Voskoboinik
Address 64068 0
Heart Centre, Alfred Hospital, Commercial Rd, Prahran, Vic, 3181
Country 64068 0
Australia
Phone 64068 0
+61 3 90762000
Fax 64068 0
+61 3 80800747
Email 64068 0
[email protected]

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

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCardioversion of atrial fibrillation in obese patients: Results from the Cardioversion-BMI randomized controlled trial.2019https://dx.doi.org/10.1111/jce.13786
N.B. These documents automatically identified may not have been verified by the study sponsor.