Catheter Ablation Versus Anti-arrhythmic Drugs for Premature Ventricular Complexes

Official title

Catheter Ablation Versus Anti-arrhythmic Drugs for Premature Ventricular Complexes (CAAD-PVC): A Randomised Controlled Trial Pilot Study

Overview

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

• Procedure Catheter 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
• Drug Medical 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

Primary outcome measures

• Change in premature ventricular complex burden [Time frame: Comparison of premature ventricular complex burden at enrolment to premature ventricular complex burden 3 months post commencement of treatment]

Secondary outcome measures (10)

• 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 [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) [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 [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 [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 [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 [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 [Time frame: Assessed over the 6 months following commencement of treatment post randomization]
• Adverse Events - Catheter Ablation Arm [Time frame: Assessed over the 6 months following commencement of treatment post randomization]
• Health service utilization [Time frame: From commencement of treatment until 12 months post treatment]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Australia · 1 center

• Westmead Hospital — Westmead

Identifiers

NCT: NCT07445334 · 2025/ETH01234

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗