None listed
Conditions
Brief summary
The REMEDIAL study aims to better understand the effect of irregular heart rhythm (atrial fibrillation) on human feelings, emotions, clarity of thinking and intellect that impact one's level of functioning and how further management of this condition influences the human mind-heart relationship. Specifically, we intend to study whether management with catheter ablation (a medical procedure for atrial fibrillation) compared with medical therapy (continued treatment with medicines) improves one's level of functioning in these important areas that impact the quality of life. We hypothesise that this common heart rhythm irregularity causes significant psychological distress and impacts one's intellect and quality of life. We also hypothesise that successful management of atrial fibrillation with catheter ablation will result in a significantly greater improvement in markers of psychological distress and neurocognitive function compared to ongoing medical management.
Interventions
Catheter ablation for atrial fibrillation: Patients who are randomly allocated to undergo catheter ablation will undergo this procedure electively in the electrophysiology lab and will be performed by a cardiac electrophysiologist in a public hospital under general anaesthesia. Patients in the interventional arm will also continue to receive standard care in the form of medications including anti-arrhythmic medications, rate controllers and drugs for systemic anticoagulation as deemed appropriat
Catheter ablation for atrial fibrillation: Patients who are randomly allocated to undergo catheter ablation will undergo this procedure electively in the electrophysiology lab and will be performed by a cardiac electrophysiologist in a public hospital under general anaesthesia. Patients in the interventional arm will also continue to receive standard care in the form of medications including anti-arrhythmic medications, rate controllers and drugs for systemic anticoagulation as deemed appropriate by the treating cardiac electrophysiologist for the duration of the study.
Sponsors
Prof Jonathan Kalman
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Paroxysmal and persistent atrial fibrillation Able to give valid consent
Exclusion criteria
Severe valvular heart disease Patients treated for suicidal ideation Patients being treated for severe depression, anxiety or mood disorders Pre-existing neurological or clinically evident neurovascular condition Anticipated difficulty with neurocognitive assessment (deafness, language difficulties) Contraindication for systemic anticoagulation Patients who sustain a new cerebrovascular accident during study period Rheumatic mitral valve disease Pregnancy
Outcome results
None listed