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

Not Applicable

Completed

• Conditions: Atrial fibrillation; Psychological distress; Neurocognitive function; Mental Health - Anxiety; Mental Health - Depression; Mental Health - Other mental health disorders

• Registration Number: ACTRN12618000062224
• Lead Sponsor: Prof Jonathan Kalman

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-17
• Study Completion: 2022-04-29
• Last Update Posted: 10 April 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hospital emotional distress as measured using Hospital Anxiety and Depression Scale score[Baseline, 3, 6, 9 and 12 months (primary time point) after randomisation];Composite outcome of Cognitive ability as assessed by results of Trail Making tests A and B'[Baseline, 3, 6, 9, 12 (primary time point), 18 and 24 months ];Arrhythmia free survival at 12 months post catheter ablation. <br>Patients were followed up either face to face and via telephone at 3, 6, and 12 months post ablation. Intensive rhythm monitoring with either intracardiac monitoring (Implantable loop recorder or permanent pacemaker), or AliveCor twice daily was used to detect arrhythmia recurrences and estimate the AF burden. <br>[12 months post catheter ablation. ]