Premature Ventricular Beats, Premature Ventricular Complexes, Premature Ventricular Contraction (PVC)
Conditions
Keywords
PVC, catheter ablation, Premature Ventricular Complexes, anti-arrhythmic medication, beta blocker
Brief summary
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.
Interventions
PROCEDURECatheter ablation
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.
DRUGMedical therapy: Anti-arrhythmic drugs (AAD) and/or beta-adrenergic blocking agents (BB)
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.
Sponsors
Western Sydney Local Health District
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Randomization will be performed using a secure, password-protected web portal (REDCap) and the allocation sequence will be blinded to investigators and participants until the participants have been deemed eligible and enrolled in the study. It will not be possible to maintain blinding after study enrollment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Premature ventricular complex burden of at least 10%, as determined by multiday (\>24-hour) heart rhythm monitoring * Normal left ventricular ejection fraction * Aged ≥18 years.
Exclusion criteria
* Unable or unwilling to provide informed consent or comply with study requirements including study investigations and follow-up, medical adherence, completion of intervention. * Women who are pregnant or breast feeding. * Life expectancy ≤ 12 months. * Ventricular tachycardia (VT) that is inducible lasting 10 seconds or more; spontaneously occurring lasting 30 seconds or more or not hemodynamically tolerated); or 10 or more episodes of non-sustained ventricular tachycardia (defined as more than five sequential beats, lasting no more than 10 seconds) in 24 hours during ambulatory heart rhythm recording. * Structural heart disease including clinically significant coronary artery, valvular disease or clinically significant myocardial replacement. * Known cardiac channelopathies (e.g. Catecholaminergic polymorphic ventricular tachycardia (CPVT), long- or short QT syndrome, Brugada syndrome). * Responsible primary care or other responsible physician believes it is not appropriate to participate in the study or unable to complete the study procedures, e.g. concomitant illness, physical impairment or mental condition which could interfere with the conduct of the study including outcome assessments.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in premature ventricular complex burden | Comparison of premature ventricular complex burden at enrolment to premature ventricular complex burden 3 months post commencement of treatment | Change in premature ventricular complex burden as measured by multiday heart rhythm monitoring at median 3 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Premature ventricular complex burden as measured by ≥24-hour heart rhythm monitoring heart at median 6 months. | Comparison of premature ventricular complexes burden at enrolment to premature ventricular complex burden at a median of 6 months post commencement of treatment | Overall premature ventricular complex burden as measured by ≥24-hour heart rhythm monitoring heart at median 6 months. |
| Left ventricular function | Prior to or at enrollment and again at 6 months post commencement of treatment | 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. |
| Quality of Life score as measured by the Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia (ASTA) | Quality of Life questionnaire completed at enrolment and again at 6 months post commencement of treatment | Quality of Life score as measured by questionnaire Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia (ASTA) |
| Quality of Life score as measured by the 36-Item Short Form Survey Instrument (SF-36) questionnaire | 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 Implanted Cardioverter-Defibrillator Concerns (ICDC) Questionnaire | 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 Depression, Anxiety and Stress Scale -21 Items (DASS-21) questionnaire | 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 |
| Number of patients with ≥75%, ≥90%, ≥95% reduction in burden | 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 | 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 |
| Adverse Events - Medical Therapy Arm | Assessed over the 6 months following commencement of treatment post randomization | Assessment and description of adverse events associated with the prescribed medical therapy |
| Adverse Events - Catheter Ablation Arm | Assessed over the 6 months following commencement of treatment post randomization | Assessment and description of adverse events associated with the catheter ablation procedure |
| Health service utilization | From commencement of treatment until 12 months post treatment | Incidence of cardiovascular hospital admissions or consultations occurring for each patient |
Countries
Australia
Contacts
CONTACTSaurabh Kumar, MBBS, PhD
CONTACTSam Turnbull
PRINCIPAL_INVESTIGATORSaurabh Kumar, MBBS, PhD
Western Sydney Local Health District
Outcome results
None listed