Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000546459p
Ethics application status
Submitted, not yet approved
Date submitted
4/05/2025
Date registered
29/05/2025
Date last updated
29/05/2025
Date data sharing statement initially provided
29/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
PACEmaker AUGMENTed AF ablation in participants with atrial fibrillation (AF) and sinus node disease – the PACE AUGMENT-AF Study.
Scientific title
Effectiveness of PACEmaker AUGMENTed AF ablation for Improved Outcomes in participants with AF and sinus node disease – the PACE AUGMENT-AF Study.
Secondary ID [1] 314349 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
atrial fibrillation 337331 0
Condition category
Condition code
Cardiovascular 333714 333714 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomised control trial for older patients with both atrial fibrillation (AF) and sinus node dysfunction to expore whether pacemaker programming can decrease the risk of AF recurrence following catheter ablation. All patients will recieve catheter ablation for AF. Patients in the intervention arm will have their pacemaker programmed to a higher atrial pacing rate - termed "increased atrial pacing" (Dual-chamber rate-modulated (DDDR) at 70bpm for all patients in the intervention arm) which will be reprogrammed by the study investigators at the randomisation visit. Patients will be followed up at 3, 6, 9 and 12 months post randomisation, where data from the pacemaker can be reviewed to check adherence to the intervention
Intervention code [1] 330962 0
Treatment: Other
Intervention code [2] 331046 0
Treatment: Devices
Comparator / control treatment
All patients with undergo catheter ablation for AF. The comparator arm will have their pacemaker programmed to a lower atrial pacing rate - termed "back-up atrial pacing" (lower rate of 30). Patients will be followed up at 3, 6, 9 and 12 months post randomisation.
Control group
Active

Outcomes
Primary outcome [1] 341307 0
The primary endpoint will be AF burden at 12 months
Timepoint [1] 341307 0
12 months post randomisation
Secondary outcome [1] 447087 0
Time to first AF recurrence
Timepoint [1] 447087 0
up to 12 months post randomisation, assessed every 3 months
Secondary outcome [2] 447088 0
Syncopal episodes
Timepoint [2] 447088 0
3, 6, 9, 12 months post randomisation
Secondary outcome [3] 447089 0
Atrial ectopic burden
Timepoint [3] 447089 0
12 months post randomisation
Secondary outcome [4] 447090 0
Quality of life through Atrial Fibrillation Effect on QualiTy-of-life (AFEQT)
Timepoint [4] 447090 0
Baseline, 6 month and 12 months post randomisation
Secondary outcome [5] 447108 0
Change in functional status from baseline
Timepoint [5] 447108 0
Baseline and 12 months post randomisation
Secondary outcome [6] 447109 0
Change in echocardiographic characteristics from baseline
Timepoint [6] 447109 0
Baseline and 12 months post randomisation
Secondary outcome [7] 447110 0
Health carer utilisation
Timepoint [7] 447110 0
12 months post randomisation
Secondary outcome [8] 447111 0
Procedure related complications
Timepoint [8] 447111 0
12 months post randomisation
Secondary outcome [9] 447112 0
Mortality
Timepoint [9] 447112 0
12 months post randomisation
Secondary outcome [10] 448027 0
Quality of life
Timepoint [10] 448027 0
Baseline, 6 months and 12 months post randomisation
Secondary outcome [11] 448028 0
Cardiovascular mortality
Timepoint [11] 448028 0
12 months post randomisation

Eligibility
Key inclusion criteria
Age greater than or equal to 65
Persistent AF, undergoing AF catheter ablation
Ongoing documented sinus node disease at least 1 month following catheter ablation, defined as:
- Fatigue, presyncope, dyspnoea, reduced exercise tolerance, or other symptoms that can correlate with slower heart rate, and at least one of the following: Mean sinus rhythm heart rate 80% max predicted heart rate on exercise stress test OR Mean sinus rhythm heart rate <60bpm on Holter monitor
Medicare eligible, able to consent, and able to adhere to follow-up requirements
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindication to catheter ablation or pacemaker implantation.

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)
Allocation concealment: clinicians referring participants for inclusion in the trial will not be aware, when this decision was made, to which group the subject will be allocated. Allocation concealment will occur through central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patient meeting eligibility following baseline screening will undergo baseline assessments and will subsequently be computer randomised in a 1:1 fashion through simple randomisation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed according to treatment allocation (increased atrial pacing or no increased atrial pacing) on an intention-to-treat basis. Normally distributed continuous data will be summarized as mean ± standard deviation and analysed by the Student’s t-test. Skewed continuous data will be presented as median with interquartile range and were analysed using the Mann-Whitney U test. Categorical variables will be presented as frequency (%) and were analysed using the Chi-squared test. A two-sided P-value of <0.05 will be considered statistically significant. Time-to-event outcomes will be analysed using Kaplan-Meier survival curves in an intention-to-treat analysis, utilising the log-rank test with 1 degree of freedom. Hazard ratios (HR) and 95% confidence intervals (CI) for time to event outcomes will be estimated using univariate Cox’s proportional hazards modelling.

The power calculation is based on the DISCERN-AF study, which investigated atrial fibrillation burden after catheter ablation through continuous monitoring (n=50, mean atrial fibrillation burden post ablation 1.39%+/-0.83%). We expect a 30% further reduction in atrial fibrillation burden in the intervention arm, requiring a final sample size of 150 participants (75 participants per arm), for statistical power of 80% and alpha of 0.05, which includes accounting for a 10% dropout rate and 10% crossover rate.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/06/2025
Actual
Date of last participant enrolment
Anticipated
31/07/2026
Actual
Date of last data collection
Anticipated
31/07/2027
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318868 0
Self funded/Unfunded
Name [1] 318868 0
Country [1] 318868 0
Primary sponsor type
Hospital
Name
Alfred Health
Address
Country
Australia
Secondary sponsor category [1] 321327 0
None
Name [1] 321327 0
Address [1] 321327 0
Country [1] 321327 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317482 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 317482 0
Ethics committee country [1] 317482 0
Australia
Date submitted for ethics approval [1] 317482 0
19/12/2024
Approval date [1] 317482 0
Ethics approval number [1] 317482 0

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

Contacts
Principal investigator
Name 141194 0
A/Prof Sandeep Prabhu
Address 141194 0
The Heart Centre at the Alfred, Commercial Rd, Melbourne, Victoria, 3004
Country 141194 0
Australia
Phone 141194 0
+61 390763522
Fax 141194 0
Email 141194 0
[email protected]
Contact person for public queries
Name 141195 0
Dr Kenneth Cho
Address 141195 0
Department of Cardiology Alfred Hospital 55 Commercial Rd, Melbourne VIC 3004
Country 141195 0
Australia
Phone 141195 0
+61 390762000
Fax 141195 0
Email 141195 0
[email protected]
Contact person for scientific queries
Name 141196 0
Dr Kenneth Cho
Address 141196 0
Department of Cardiology Alfred Hospital 55 Commercial Rd, Melbourne VIC 3004
Country 141196 0
Australia
Phone 141196 0
+61 390762000
Fax 141196 0
Email 141196 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Data collected will be deidentified for data analysis and aggregation purposes. This is to maintain the integrity of the data collected.



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
No additional documents have been identified.