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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]

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

Obesity

Condition category

Condition code

Cardiovascular

Other cardiovascular diseases

Diet and Nutrition

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]

Treatment: Other

Intervention code [2]

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]

Rate of successful cardioversion (either 1st or 2nd shock) - as determined by rhythm strip or ECG during the procedure.

Timepoint [1]

On day of cardioversion

Primary outcome [2]

Rate of successful cardioversion by modality (ie. patch or paddle) - as determined by rhythm strip or ECG during the procedure.

Timepoint [2]

On day of cardioversion

Secondary outcome [1]

Rate of successful cardioversion with 1st shock - as determined by rhythm strip or ECG during the procedure.

Timepoint [1]

On day of cardioversion

Secondary outcome [2]

Rate of successful cardioversion (either 3 shocks) per patient - as determined by rhythm strip or ECG during the procedure.

Timepoint [2]

On day of cardioversion

Secondary outcome [3]

Presence of sinus rhythm at end of procedure (by ECG).

Timepoint [3]

On day of cardioversion

Secondary outcome [4]

Cumulative energy use (Joules) - assessed by adding total amount of energy used for all shocks per patient.

Timepoint [4]

On day of cardioversion

Secondary outcome [5]

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]

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?

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]

The Alfred - Prahran

Recruitment hospital [2]

Royal Melbourne Hospital - City campus - Parkville

Recruitment hospital [3]

Cabrini Hospital - Prahran - Prahran East

Recruitment hospital [4]

Melbourne Private Hospital - Parkville

Recruitment hospital [5]

Western Hospital - Footscray

Recruitment hospital [6]

Sunshine Hospital - St Albans

Recruitment hospital [7]

Monash Medical Centre - Clayton campus - Clayton

Recruitment postcode(s) [1]

3181 - Prahran

Recruitment postcode(s) [2]

3144 - Malvern

Recruitment postcode(s) [3]

3052 - Parkville

Recruitment postcode(s) [4]

3011 - Footscray

Recruitment postcode(s) [5]

3021 - St Albans

Recruitment postcode(s) [6]

3168 - Clayton

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Prof Peter Kistler

Address [1]

Heart Centre, Alfred Hospital, Commercial Rd, Prahran, Vic, 3185

Country [1]

Australia

Funding source category [2]

Hospital

Name [2]

Alfred Hospital

Address [2]

Commercial Rd, Prahran, Vic, 3181

Country [2]

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]

Individual

Name [1]

Dr Aleksandr Voskoboinik

Address [1]

Heart Centre, Alfred Hospital, Commercial Rd, Prahran, Vic, 3181

Country [1]

Australia

Other collaborator category [1]

Individual

Name [1]

Prof Jonathan Kalman

Address [1]

Department of Cardiology, Royal Melbourne Hospital, Grattan St, Parkville, Vic, 3052

Country [1]

Australia

Other collaborator category [2]

Individual

Name [2]

Dr Michael Wong

Address [2]

Department of Cardiology, Western Hospital, Gordon St, Footscray, Vic, 3011

Country [2]

Australia

Other collaborator category [3]

Individual

Name [3]

Dr Emily Kotschet

Address [3]

Department of Cardiology, Monash Medical Centre, Clayton Rd, Clayton, Vic, 3168

Country [3]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Health Human Research Ethics Committee

Ethics committee address [1]

Alfred Hospital, Commercial Rd, Prahran, Vic, 3181

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

27/01/2016

Approval date [1]

02/03/2016

Ethics approval number [1]

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

Prof Peter Kistler

Address

Heart Centre, Alfred Hospital, Commercial Rd, Prahran, Vic, 3181

Country

Australia

Phone

+61 3 90766525

Fax

+61 3 9076 2461

[email protected]

Contact person for public queries

Name

Aleksandr Voskoboinik

Address

Heart Centre, Alfred Hospital, Commercial Rd, Prahran, Vic, 3181

Country

Australia

Phone

+61 3 90762000

Fax

+61 3 80800747

[email protected]

Contact person for scientific queries

Name

Aleksandr Voskoboinik

Address

Heart Centre, Alfred Hospital, Commercial Rd, Prahran, Vic, 3181

Country

Australia

Phone

+61 3 90762000

Fax

+61 3 80800747

[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

Source	Title	Year of Publication	DOI
Embase	Cardioversion of atrial fibrillation in obese patients: Results from the Cardioversion-BMI randomized controlled trial.	2019	https://dx.doi.org/10.1111/jce.13786

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically