Catheter Ablation Versus Anti-arrhythmic Drugs for Premature Ventricular Complexes (CAAD-PVC): A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Proportion of participants with ≥80% reduction in PVC burden
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PVC burden of ≥10% as determined by ≥24-hour heart rhythm monitoring.
- •Normal left ventricular ejection fraction, defined as ejection fraction ≥50%.
- •Aged ≥18 years.
- •Symptoms due to PVCs according to the judgement of the treating physician.
排除标准
- •Unable or unwilling to provide informed consent or comply with study requirements including study investigations, follow-up, medical adherence and completion of the assigned intervention.
- •Women who are pregnant or breastfeeding.
- •Life expectancy ≤12 months.
- •Ventricular tachycardia (VT), defined as spontaneous VT lasting ≥30 seconds, haemodynamically unstable VT of any duration, inducible sustained VT during any electrophysiology study, or ≥10 episodes of non-sustained VT (>5 consecutive beats lasting ≤30 seconds) within 24 hours on heart rhythm monitoring.
- •Previous catheter ablation for ventricular arrhythmia.
- •Clinically significant coronary artery disease, defined as a history of myocardial infarction, prior coronary revascularisation, inducible ischaemia on functional testing or obstructive coronary artery disease on coronary imaging. Any type of coronary assessment is permitted, although computed tomography coronary angiography is encouraged.
- •Moderate or greater valvular heart disease.
- •Known non-ischaemic or ischaemic cardiomyopathy or evidence of myocardial scar on cardiac magnetic resonance imaging suggestive of structural heart disease.
- •Known cardiac channelopathies including catecholaminergic polymorphic ventricular tachycardia (CPVT), Brugada syndrome and long- or short-QT syndrome.
- •In the opinion of the investigator or responsible physician, participation would not be in the patient's best interest or the patient would be unable to complete study procedures because of concomitant illness, physical impairment or mental condition.
研究组 & 干预措施
Medical therapy: Anti-arrhythmic drugs (AAD) and/or beta-adrenergic blocking agents (BB)
Participants randomised to medical therapy will be managed with medical therapy alone by their usual medical practitioners. The objective is to replicate standard care for patients with PVCs managed using a non-interventional approach.
The protocol recommends sotalol, starting at 40 mg twice daily and uptitrating to 80 mg twice daily after at least one week as tolerated; minimum total daily dose is 40 mg and maximum total daily dose is 320 mg. If sotalol is contraindicated or not tolerated, metoprolol is recommended, starting at 25 mg twice daily and uptitrating to a maximum total daily dose of 300 mg. Verapamil or diltiazem may be considered when beta blockers are contraindicated; flecainide may be considered if coronary artery disease and structural heart disease have been ruled out. AADs may be changed at any time according to clinical response. Ultimately, the choice of AADs will be left to the treating physician who does not need to follow the above recommendations.
干预措施: Medical therapy: Anti-arrhythmic drugs (AAD) and/or beta-adrenergic blocking agents (BB) (Drug)
Catheter ablation
Participants randomised to catheter ablation will be expected to undergo catheter ablation for PVCs within 2 weeks after randomisation. Medical therapy may be used as a temporising measure before ablation as standard care. If the participant is drug-naïve, initiation of sotalol is recommended but not mandated. Medical therapy for PVCs should be discontinued after ablation and at least five half-lives before ablation. Repeat ablation procedures will be discouraged during the 12-week monitoring period although if PVC quiescence prevents targeted ablation, one repeat ablation attempt may be undertaken within two weeks.
Ablation will be guided by a combination of standard mapping techniques, as per standard practice. Preference will be given to "activation mapping" of the PVCs (which may be stimulated by administration of intravenous isoprenaline) using a three-dimensional electroanatomic mapping system. If there is paucity of PVCs, then "pace-mapping" will be performed.
干预措施: Catheter ablation (Procedure)
结局指标
主要结局
Proportion of participants with ≥80% reduction in PVC burden
时间窗: Baseline to 12 weeks after randomisation
Number of participants achieving at least an 80% reduction in PVC burden, measured by ≥24-hour heart rhythm monitoring and compared with baseline PVC burden.
Change in premature ventricular complex burden
时间窗: 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.
次要结局
- Change in PVC burden(Baseline to 12 weeks after randomisation)
- Proportion of participants with ≥99% reduction in PVC burden(Baseline to 12 weeks after randomisation)
- ASTA quality-of-life score(Baseline, 6 weeks and 12 weeks after randomisation)
- DASS-21 score(Baseline, 6 weeks and 12 weeks after randomisation)
- EQ-5D-5L score(Baseline, 6 weeks and 12 weeks after randomisation)
- Tolerability of medical therapy(From randomisation to 12 weeks)
- Tolerability of catheter ablation(From randomisation to 12 weeks)
- Health service utilisation(From randomisation to 12 weeks)
- 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)
- Left ventricular function(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 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 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 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 questionnaire completed at enrolment and again at 6 months post commencement of treatment)
- 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)
- Adverse Events - Medical Therapy Arm(Assessed over the 6 months following commencement of treatment post randomization)
- Adverse Events - Catheter Ablation Arm(Assessed over the 6 months following commencement of treatment post randomization)
- Health service utilization(From commencement of treatment until 12 months post treatment)
研究者
Saurabh Kumar
Associate Professor
Western Sydney Local Health District