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Australian Clinical Trials

Clinical Trial Details

Clinical impact and treatment outcomes of irregular heart rhythm on human feelings, emotions and intellect

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Trial Information

Broad Health Condition Mental Health
Mental Health
Mental Health

Specific Health ConditionAnxiety
Other mental health disorders

Trial FocusTreatment

Recruitment Details

Recruitment status

Recruitment State

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

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?Further information iconApproved

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
Contact details and further information

Sponsor Primary Sponsor Type: Individual
Primary Sponsor Name: Prof Jonathan Kalman
Primary Sponsor Address: Department of Cardiology, Royal Melbourne Hospital - City Campus Level 2, 300 Grattan Street, Parkville. VIC 3050
Primary Sponsor Country: Australia

Trial IDACTRN12618000062224


Contact person for information and recruitmentDr
Ramanathan Parameswaran
Department of Cardiology, Royal Melbourne Hospital - City Campus Level 2, 300 Grattan Street, Parkville. VIC 3050
+61 3 9342 7000

Email contact Further information