None listed
Conditions
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.
Interventions
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 clinica
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.
Sponsors
The Royal Melbourne Hospital
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
67 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed