Australian Clinical Trials

Broad Health Condition Mental Health
Mental Health
Mental Health

Specific Health ConditionAnxiety
Depression
Other mental health disorders

Trial FocusTreatment

Recruitment Details

Recruitment status
Completed

Recruitment State
VIC

Hospital
Royal Melbourne Hospital - City campus - Parkville
The Alfred - Prahran

Postcode
3050 - Parkville
3004 - Prahran

Anticipated date of first participant enrolment5/02/2018

Anticipated date of last participant enrolment30/04/2020

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Trial 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.

Key inclusion criteria

Paroxysmal and persistent atrial fibrillation
Able to give valid consent

Minimum age18 Years

Maximum age80 Years

GenderBoth males and females

Can Healthy volunteers participate? No

Key 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