Premature ventricular complexes (PVCs) are extra, abnormal heart beats arising from the ventricles of the heart and are the most common ventricular arrhythmia. PVCs can be treated with medication or with a procedure called catheter ablation. It is not known which provides a better cure or provides better quality of life. The purpose of this research project is to study the best way to treat PVCs by comparing the use of medication to catheter ablation to assess which approach is better at reducing symptoms and improving quality of life.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Catheter ablation (CA) of premature ventricular complexes (PVCs) will be performed in standard fashion as approved by international guidelines. CA aims to deliver therapeutic energy to the site of origin of the PVCs, rendering the tissue there incapable of causing the arrhythmia. Ablations will be performed under sedation or GA, guided by electroanatomic mapping and cardiac imaging. End point of CA will be abolition of all PVCs (with and without isoprenaline provocation) with a 30-minute waiting period. Occasionally, patients may experience episodes of PVC quiescence and an absence of PVCs on the day of CA. This can be a result of changes in medication, stress, hormones, electrolytes and can be unpredictable. As at least one PVC occurring during the CA is required to perform a CA, an episode of PVC quiescence on the day of the procedure that inhibits the ablation from taking place will not preclude the patient from having a repeat attempt at the CA.
This arm aims to replicate standard of care for patients with PVCs managed by a non-interventional approach, usually encompassing patients who have symptoms and have not previously been prescribed an AAD or BB, being commenced on an AAD and/or a BB. Choice of AAD/BB will be left to primary physician: If deferred to the trial team, clinical protocol suggests sotalol (which has both AAD and BB properties) 80mg twice daily, or a lower dose if indicated. If sotalol is contraindicated, an alternative BB may be initiated using standard doses (metoprolol, atenolol, bisoprolol). Clinicians may consider alternative AAD if BBs are contraindicated. For example, a dihydropyridine calcium channel blocker (verapamil or diltiazem) may be initiated if patient has concurrent asthma. If coronary artery disease and structural heart disease is ruled out, flecainide (class I anti-arrhythmic agent) may be used. As with clinical practice, AAD/BB can be changed at any time depending on clinical response.
Westmead Hospital
Westmead, New South Wales, Australia
Change in premature ventricular complex burden
Change in premature ventricular complex burden as measured by multiday heart rhythm monitoring at median 3 months.
Time frame: Comparison of premature ventricular complex burden at enrolment to premature ventricular complex burden 3 months post commencement of treatment
Premature ventricular complex burden as measured by ≥24-hour heart rhythm monitoring heart at median 6 months.
Overall premature ventricular complex burden as measured by ≥24-hour heart rhythm monitoring heart at median 6 months.
Time frame: Comparison of premature ventricular complexes burden at enrolment to premature ventricular complex burden at a median of 6 months post commencement of treatment
Left ventricular function
Effect of treatment on left ventricular function, (including left ventricular ejection fraction percentage and global longitudinal strain), as assessed by changes in transthoracic echocardiography at baseline and 6 months.
Time frame: Prior to or at enrollment and again at 6 months post commencement of treatment
Quality of Life score as measured by the Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia (ASTA)
Quality of Life score as measured by questionnaire Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia (ASTA)
Time frame: Quality of Life questionnaire completed at enrolment and again at 6 months post commencement of treatment
Quality of Life score as measured by the 36-Item Short Form Survey Instrument (SF-36) questionnaire
Quality of Life score as measured by the 36-Item Short Form Survey Instrument (SF-36) questionnaire
Time frame: Quality of Life questionnaire completed at enrolment and again at 6 months post commencement of treatment
Quality of Life score as measured by The Implanted Cardioverter-Defibrillator Concerns (ICDC) Questionnaire
Quality of Life score as measured by The Implanted Cardioverter-Defibrillator Concerns (ICDC) Questionnaire
Time frame: Quality of Life questionnaire completed at enrolment and again at 6 months post commencement of treatment
Quality of Life score as measured by the Depression, Anxiety and Stress Scale -21 Items (DASS-21) questionnaire
Quality of Life score as measured by the Depression, Anxiety and Stress Scale -21 Items (DASS-21) questionnaire
Time frame: Quality of Life questionnaire completed at enrolment and again at 6 months post commencement of treatment
Number of patients with ≥75%, ≥90%, ≥95% reduction in burden
Number of patients with ≥75%, ≥90%, ≥95% reduction in burden as assessed on multi-day heart rhythm monitoring compared to pre-enrollment multi-day heart rhythm monitoring
Time frame: Heart rhythm monitoring performed prior to/at enrollment and again at 3 months, with repeat multi-day heart rhythm monitoring at 6 and 12 months encouraged but not mandated
Adverse Events - Medical Therapy Arm
Assessment and description of adverse events associated with the prescribed medical therapy
Time frame: Assessed over the 6 months following commencement of treatment post randomization
Adverse Events - Catheter Ablation Arm
Assessment and description of adverse events associated with the catheter ablation procedure
Time frame: Assessed over the 6 months following commencement of treatment post randomization
Health service utilization
Incidence of cardiovascular hospital admissions or consultations occurring for each patient
Time frame: From commencement of treatment until 12 months post treatment
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