Trial Review

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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 information initially 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
Alfred Hospital, Commercial Rd, Prahran, Vic, 3181
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
Direct electrical cardioversion (DCR) is an important aspect of atrial fibrillation and/or atrial flutter (AF) management, and is routinely performed to restore normal sinus rhythm. Success rates range from 50 – 93% , depending on left atrial size, AF duration and transthoracic impedance. Total body weight is a key factor in determining transthoracic impedance and therefore cardioversion failure is more frequent in obese patients .

In a randomised trial of 201 patients, hand-held paddle electrodes successfully cardioverted 98% patients,compared to 86% with self-adhesive patches (p = 0.001) . This is likely related to the fact that handheld paddles convey a lower transthoracic impedence and hence enable more efficient delivery of energy to the left atrium . The mean body mass index (BMI) in this trial was 28. It is likely that an even greater difference would be observed with paddles in patients with higher BMIs. While a recent large meta-analysis did not demonstrate a difference in cardioversion success rates for different electrode positions / shock vectors (anterior-posterior vs antero-apical, this may not be the case for obese patients.

Currently, self-adhesive patches remain more widely utilized in Australian hospitals, due to their ease of use. However with the emerging obesity epidemic, we believe this practice is contributing to an increasing failure of DCR in this patient group.

Our study is a multi-centre randomised controlled trial comparing hand-held paddle electrodes and self-adhesive patch electrodes in obese patients (BMI at least 30). We hope to determine whether rates of successful cardioversion for AF are higher in obese patients using hand-held paddle electrodes compared with self-adhesive patch electrodes. We hypothesise that handheld paddle electrodes have a significantly higher efficacy at restoring sinus rhythm in obese patients. Our 2 x 2 design will comprehensively evaluate the best way to cardiovert obese patients (patch vs paddle AND anteroapical vs anteroposterior).

Patients will be randomised to one of four arms (2 paddle arms - 1 antero-posterior, 1 antero-apical shock vector & 2 patch arms - 1 antero-posterior, 1 antero-apical shock vector). Cardioversion will proceed until sinus rhythm is restored. Patients in each group will receive up to 2 shocks with the modality they are assigned to (patch or paddle), with the 3rd (final) shock being a cross-over to the alternative modality (patch or paddle). Additional shocks up to 360J may be delivered at the discretion of the clinician, and all patients with failed cardioversions will be offered a referral for an attempted shock up to 360J on a different date. Patients with successful cardioversions will also be contacted at 3 months to determine if they have had a recurrence of AF, and if not, will be asked to have an ECG performed.
Trial website
N/A
Trial related presentations / publications
Nil to date.
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
Dr 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
Dr 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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Voskoboinik A, Moskovitch J, Plunkett G, et al. Ca... [More Details]
Plain language summaryNo Paddles were superior to adhesive patches for card... [More Details]

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.