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Trial registered on ANZCTR
Registration number
ACTRN12626001019392
Ethics application status
Approved
Date submitted
14/07/2026
Date registered
18/08/2026
Date last updated
18/08/2026
Date data sharing statement initially provided
18/08/2026
Type of registration
Prospectively registered
Titles & IDs
Public title
Does Catheter Ablation Improve Cognitive Function Over 12 and 24 Months as Compared with Standard Medical Therapy in Patients Aged 67 years and Older with Persistent Atrial Fibrillation (AF)?: A Randomised Clinical Trial
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Scientific title
Cognitive Outcomes Over 12 and 24 Months Following Catheter Ablation Versus Optimised Medical Therapy in Patients Aged 67 Years or older with Persistent Atrial Fibrillation: A Randomised Clinical Trial
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Additional trial identifiers [1]
317380
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RMH 2025.286
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Universal Trial Number (UTN)
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Trial acronym
MIND-AF
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Related trial records
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Health condition
Health condition(s) studied:
Persistent atrial fibrillation (AF)
342042
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Cognitive function
342044
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AF related quality of life
342218
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Depression symptoms
342221
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Condition category
Condition code
Cardiovascular
338129
338129
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0
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Coronary heart disease
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Neurological
338130
338130
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0
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Other neurological disorders
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Mental Health
339138
339138
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0
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Depression
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Intervention/exposure
Study type
Interventional
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Description of the intervention or exposure
This is a prospective multicenter randomised trial of catheter ablation vs. medical therapy in patients aged 67 years or older, referred for management of persistent AF.
During the study period, heart rhythm monitoring will be performed in both arms using implantable loop recorders (ILR) for accurate documentation of AF episodes and AF burden.
Arm 1: Catheter Ablation
Participants randomised to Arm 1 will undergo catheter ablation for persistent atrial fibrillation as part of standard clinical care. A single index ablation procedure will be performed, with repeat procedures during follow-up permitted if clinically indicated according to standard care.
Ablation will be performed within 3 months of randomisation by specialist Electrophysiologists working in the study centres. Ablation will be performed according to standard protocols as per international guidelines and hospital routine practice. All patients will undergo pulmonary vein isolation (PVI) as the primary intervention which will be performed in all patients to achieve antral isolation of all PVs using the Farawave catheter (Boston Scientific). In brief, PVI is a catheter ablation procedure used to treat atrial fibrillation by creating lesions around the pulmonary veins to electrically isolate abnormal signals that trigger the arrhythmia. This helps prevent these abnormal electrical impulses from entering the left atrium and sustaining atrial fibrillation. Demonstration of PVI at completion will be required. Ablation of targets beyond PVI, including posterior left atrial wall isolation and/or cavo-tricuspid isthmus ablation may be performed as per operator discretion. When these are performed, demonstration of isolation and/or linear block will be required.
Total procedure duration is typically 45-75 minutes.
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Intervention code [1]
334170
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Treatment: Surgery
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Intervention code [2]
334171
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Treatment: Devices
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Intervention code [3]
334172
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Treatment: Drugs
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Description of the comparator or control
Arm 2: Optimised Medical Therapy
Patients randomised to Arm 2 optimised medical therapy will receive either rate or rhythm control with standard medications as recommended by international guidelines and at the physician’s discretion. These medications might include: Anti-arrhythmic medication including flecainide, sotalol or amiodarone or rate control agents such as beta-blockers, calcium channel blockers or digoxin. In addition, patients will be screened and treated for medical conditions associated with AF (eg sleep apnoea, hypertension, diabetes) and will receive advice regarding lifestyle modifications by their treating physician in accordance with international guidelines. Patients will be actively followed at 3, 6, 12, 18 and 24 months to ensure adequate response to medical therapy for the duration of the study.
See reference Guidelines:
1. 2024 ESC Guidelines for the management of atrial fibrillation
2. The Heart Foundation - Australian clinical guidelines for the diagnosis and management of atrial fibrillation
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Control group
Active
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Outcomes
Primary outcome [1]
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The primary outcome will be the difference in cognitive function between patients treated with AF catheter ablation and patients treated medically at the 12 month time-point. Analyses will be on the basis of intention to treat.
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Assessment method [1]
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For the purpose of primary outcome assessment, the Addenbrooke’s Cognitive Examination III (ACE III) will be utilized.
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Timepoint [1]
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The 12 month time point will represent the primary outcome measure. Cognitive function will be assessed at 6, 12, 18, and 24 months post randomisation.
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Secondary outcome [1]
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Cognitive function at 12 months post randomisation using a computerised Cognitive Assessment Battery - Intention to treat analysis
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Assessment method [1]
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This will be assessed as a composite outcome and will be a secondary outcome measure. At each of the key time points, we will perform a Cognitive Assessment Battery (CAB), performed on the validated CogniFit platform. The computerised battery comprises 17 cognitive tests together yielding a score on 22 narrow cognitive abilities, five broader cognitive domains (Attention, Perception, Memory, Reasoning, and Coordination), and a Global Cognition Score.
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Timepoint [1]
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6-, 12-, 18- and 24-months post randomisation
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Secondary outcome [2]
462001
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Cognitive function at 18 and 24 months post randomisation. Intention to treat analysis.
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Assessment method [2]
462001
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ACE-III evaluation
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Timepoint [2]
462001
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18- and 24-months post randomisation
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Secondary outcome [3]
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Quality of Life (QoL) assessment:
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Assessment method [3]
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We will assess AF-specific and general QoL improvements (AFEQT and SF-36, respectively) including measures of physical activity and independence. This will be achieved using validated patient questionnaires.
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Timepoint [3]
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Baseline, 6, 12, 18 and 24 months post randomisation.
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Secondary outcome [4]
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AF recurrence
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Assessment method [4]
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We will assess AF recurrence rate post randomisation using the Boston Scientific LUX-Dx Insertable Cardiac Monitor (ICM).
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Timepoint [4]
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Duration of the study, up to 24-months post randomisation
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Secondary outcome [5]
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AF-related healthcare utilisation:
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Assessment method [5]
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We will assess the AF-associated healthcare utilisation including Emergency department visits, hospitalisations, cardioversions, repeat ablations and clinic visits. This will be done via review of patient medical records from the hospital and their treating physician.
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Timepoint [5]
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Up to 24-months post randomisation, assessments will be conducted 6 monthly
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Secondary outcome [6]
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Procedural related complications
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Assessment method [6]
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The study will monitor the occurrence of procedural complications to assess safety. A record of all adverse events (AEs), including details of the nature, onset, duration, severity, relationship to technology, relationship to the operative procedure and outcome, will be made on the relevant section(s) of the subject’s Case Report Form (CRF). At each follow-up visit, subjects will be questioned regarding their general health. If it is determined that an AE has occurred, the investigator will obtain all the information required to complete the AE Form of the CRF. In addition, patients will be instructed to contact the investigator, and/or study coordinator to notify any significant adverse event occurring between study evaluation visits. All AEs will be followed until resolution or until a stable clinical state is reached. All required treatments and outcomes of the adverse event must be recorded.
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Timepoint [6]
462785
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Up to 24-months post randomisation, assessments will be conducted 6 monthly
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Secondary outcome [7]
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Drug related complications
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Assessment method [7]
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The study will monitor the occurrence of drug related complications to assess safety. A record of all adverse events (AEs), including details of the nature, onset, duration, severity, relationship to medical treatment, will be made on the relevant section(s) of the subject’s Case Report Form (CRF). At each follow-up visit, subjects will be questioned regarding their general health. If it is determined that an AE has occurred, the investigator will obtain all the information required to complete the AE Form of the CRF. In addition, patients will be instructed to contact the investigator, and/or study coordinator to notify any significant adverse event occurring between study evaluation visits. All AEs will be followed until resolution or until a stable clinical state is reached. All required treatments and outcomes of the adverse event must be recorded.
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Timepoint [7]
465584
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Up to 24-months post randomisation, assessments will be conducted 6 monthly
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Secondary outcome [8]
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AF burden
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Assessment method [8]
465585
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We will assess AF burden post randomisation using the Boston Scientific LUX-Dx Insertable Cardiac Monitor (ICM).
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Timepoint [8]
465585
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Duration of the study, up to 24-months post randomisation
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Secondary outcome [9]
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Cognitive function
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Assessment method [9]
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Computerised comprehensive cognitive assessment battery (Cognifit)
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Timepoint [9]
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6-, 12-, 18- and 24-months post randomisation
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Secondary outcome [10]
466172
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Quality of Life (QoL) assessment:
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Assessment method [10]
466172
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Atrial Fibrillation Effect on QualitTy-of-life (AFEQT) evaluates how AF and its symptoms impact the patient’s daily life, physical functioning, and overall well-being.
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Timepoint [10]
466172
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6-, 12-, 18- and 24-months post randomisation
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Eligibility
Key inclusion criteria
1) Age 67 years or older
2) Persistent or long-lasting persistent AF
3) ACE-III score >82 at baseline to exclude existing cognitive impairment
4) Eligibility for both catheter ablation and medical therapy
5) Ability to provide informed consent
6) Cavo-tricuspid isthmus (CTI) ablation may be performed in these patients as part of the index procedure (History of prior CTI ablation will not be an exclusion criterion as well)
7) Patients who had 1 prior AF ablation procedure with subsequent PersAF recurrence will be eligible to be included in the study
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Minimum age
67
Years
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Maximum age
No limit
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Sex
Both males and females
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Healthy volunteers
No
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Key exclusion criteria
1) Highly symptomatic AF despite medical therapy; patient preference is for ablation
2) More than 1 prior AF ablation procedures (1 prior AF ablation procedure as well as prior ablation of the cavo-tricuspid isthmus alone is not an exclusion if the patient develops subsequent/recurrent AF. Planned atrial flutter ablation in combination with the left atrial ablation is also not an exclusion).
3) History of atypical (left-atrial) flutter
4) Prior left atrial appendage closure
5) AF of continuous duration >5 years
6) Significant cognitive impairment (ACE-III=82).
7) Left ventricular ejection fraction (LVEF)<40% or NYHA Class IV CHF
8) Severe comorbidities limiting life expectancy to <1 year.
9) Contraindications to anticoagulation
10) Significant valvular heart disease
11) Reversible causes of AF including thyroid disorders, acute alcohol intoxication, recent major surgical procedures, or trauma
12) Recent cardiac events including MI, PCI, or valve or bypass surgery in the preceding 3 months
13) Hypertrophic cardiomyopathy
14) Coronary artery disease requiring intervention
15) Other arrhythmias mandating anti-arrhythmic drug therapy (eg VT, VF)
16) Prior surgical interventions for AF such as the MAZE procedure
17) Prior AV nodal ablation
18) Patients with other arrhythmias requiring ablative therapy
19) Renal failure pre-dialysis or requiring dialysis
20) Unable to give informed consent
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central allocation using a secure REDCap randomisation module.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation sequence will be generated using the REDCap randomisation module with a computer-generated random allocation sequence.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
In preparation for data analysis, all raw data will be inspected for completeness and nature
of missing data will be evaluated and if indicated, estimated. Outliers will be identified and
corrected as appropriate.
Categorical variables will be reported as count and percentages, while continuous variables as mean and standard deviations (SD). Continuous outcomes at each endpoint can be analysed using a 2 sample t-test. A p-value <0.05 will be considered significant.
All primary analyses will be based on an intention-to-treat model.
Secondary analyses will include an evaluation of cognitive outcome according to AF burden.
Analysis of the primary and secondary endpoints will be conducted using Mixed Linear Models with assessment time point and group (ablation vs. control) as fixed factors with random intercepts and slopes for participants. Mean treatment differences between groups at baseline and at each follow-up period will be estimated from this model.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/09/2026
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Actual
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Date of last participant enrolment
Anticipated
31/05/2030
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Actual
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Date of last data collection
Anticipated
30/05/2032
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Actual
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Sample size
Target
324
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
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Recruitment hospital [1]
29581
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Royal Melbourne Hospital - City campus - Parkville
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Recruitment hospital [2]
29582
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The Alfred - Melbourne
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Recruitment hospital [3]
29583
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St John of God Hospital, Geelong - Geelong
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Recruitment hospital [4]
29584
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Box Hill Hospital - Box Hill
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Recruitment hospital [5]
29585
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Austin Health - Austin Hospital - Heidelberg
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Recruitment hospital [6]
29586
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The Royal Adelaide Hospital - Adelaide
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Recruitment hospital [7]
29587
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Royal Hobart Hospital - Hobart
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Recruitment hospital [8]
29588
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [9]
29589
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Westmead Hospital - Westmead
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Recruitment hospital [10]
29590
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The Prince Charles Hospital - Chermside
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Recruitment hospital [11]
29591
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Flinders Medical Centre - Bedford Park
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Recruitment hospital [12]
29592
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John Hunter Hospital - New Lambton
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Recruitment postcode(s) [1]
45910
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3050 - Parkville
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Recruitment postcode(s) [2]
45911
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3004 - Melbourne
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Recruitment postcode(s) [3]
45912
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3220 - Geelong
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Recruitment postcode(s) [4]
45913
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3128 - Box Hill
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Recruitment postcode(s) [5]
45914
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3084 - Heidelberg
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Recruitment postcode(s) [6]
45915
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5000 - Adelaide
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Recruitment postcode(s) [7]
45916
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7000 - Hobart
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Recruitment postcode(s) [8]
45917
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2050 - Camperdown
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Recruitment postcode(s) [9]
45918
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2145 - Westmead
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Recruitment postcode(s) [10]
45919
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4032 - Chermside
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Recruitment postcode(s) [11]
45920
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5042 - Bedford Park
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Recruitment postcode(s) [12]
45921
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2305 - New Lambton
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Funding & Sponsors
Funding source category [1]
321954
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Government body
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Name [1]
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National Health and Medical Research Council (NHMRC)
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Address [1]
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Country [1]
321954
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Australia
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Funding source category [2]
321956
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Other Collaborative groups
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Name [2]
321956
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Boston Scientific
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Address [2]
321956
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Country [2]
321956
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Australia
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Primary sponsor type
Hospital
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Name
The Royal Melbourne Hospital
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Address
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Country
Australia
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Secondary sponsor category [1]
324830
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None
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Name [1]
324830
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Address [1]
324830
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Country [1]
324830
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
320491
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The Royal Melbourne Hospital Human Research Ethics Committee
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Ethics committee address [1]
320491
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https://www.thermh.org.au/research/researchers/ethics
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Ethics committee country [1]
320491
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Australia
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Date submitted for ethics approval [1]
320491
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19/10/2025
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Approval date [1]
320491
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29/01/2026
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Ethics approval number [1]
320491
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Summary
Brief summary
This study aims to determine whether catheter ablation improves cognitive function compared with optimised medical therapy in adults aged 67 years and older with persistent atrial fibrillation. Participants will be randomly assigned to receive either catheter ablation or guideline-directed medical therapy and followed for up to 24 months. Cognitive function will be assessed using validated neurocognitive assessments at baseline, 6, 12, 18 and 24 months, with cognitive function at 12 months as the primary outcome. Secondary outcomes include cognitive function at 6, 18 and 24 months, quality of life, atrial fibrillation recurrence and burden, healthcare utilisation, and safety outcomes. The study hypothesis is that catheter ablation will be associated with better cognitive function as compared with medical therapy alone.
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Trial website
https://www.melbourneheartrhythm.com.au/
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Jonathan Kalman
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Address
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Royal Melbourne Hospital - 300 Grattan St, Parkville 3050 VIC
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Country
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Australia
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Phone
150642
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+61 3 9349 5400
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Fax
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Email
150642
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[email protected]
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Contact person for public queries
Name
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Laura Chen
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Address
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Royal Melbourne Hospital - 300 Grattan St, Parkville 3050 VIC
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Country
150643
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Australia
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Phone
150643
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+61 459 869 123
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Fax
150643
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Email
150643
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[email protected]
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Contact person for scientific queries
Name
150644
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Dr. Leonid Maizels
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Address
150644
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Royal Melbourne Hospital - 300 Grattan St, Parkville 3050 VIC
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Country
150644
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Australia
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Phone
150644
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+61 3 9342 7000
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Fax
150644
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Email
150644
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
•
Researchers
Conditions for requesting access:
•
Yes, conditions apply:
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Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
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Requires a scientifically sound proposal or protocol
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Requires approval by an ethics committee
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Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
•
De-identified individual participant data:
•
Published results
•
Primary outcome(s)
•
Safety data
What types of analyses could be done with individual participant data?
•
Systematic reviews and meta-analyses
•
Studies exploring new research questions
•
Health economic analyses
•
Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
•
Email of trial custodian, sponsor or committee:
[email protected]
Are there extra considerations when requesting access to individual participant data?
Yes:
Access to de-identified participant data may be considered after publication of the primary study results, subject to review and approval by the study investigators and relevant ethics and institutional governance processes. Data sharing will require an appropriate data sharing agreement and a scientifically sound research proposal.
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.
Download to PDF