Catheter Ablation Versus Anti-arrhythmic Drugs for Premature Ventricular Complexes (CAAD-PVC): A Randomised Controlled Trial Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in premature ventricular complex 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
- •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.
排除标准
- •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.
研究组 & 干预措施
Catheter ablation
Catheter ablation (CA) will be performed within 6 weeks of randomisation, following standard practices approved by international guidelines. Medication for PVCs may be halted one week or five half-lives prior to CA. Procedures will be performed under conscious sedation or general anesthesia. Vascular access will be obtained from the femoral vein and or artery and electrode catheters to the coronary sinus, right ventricle and/or the left ventricle (by transseptal puncture or retrograde aortic approach).
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.
End point of ablation will be abolition of all PVCs (with and without isoprenaline provocation) with a 30-minute waiting period.
干预措施: Catheter ablation (Procedure)
Medical therapy: Anti-arrhythmic drugs (AAD) and/or beta-adrenergic blocking agents (BB)
Medical therapy: Anti-arrhythmic drugs (AAD) and/or beta-adrenergic blocking agents (BB).
Patients randomised to the control arm will be managed with medical therapy alone by their usual medical practitioners. The objective of this arm is that it replicates what would constitute standard of care for patients with PVCs managed with a non-interventional approach.
Standard clinical care would usually encompass 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 however if this is deferred to the trial team, clinical protocol would suggest sotalol 80mg twice daily - a commonly medication that has both AAD and BB properties. A lower dose may be initiated by the treating physician, as clinically indicated.
If sotalol is contraindicated, an alternative BB may be initiated using standard doses e.g. metoprolol, atenolol, bisoprolol, carvedilol.
干预措施: Medical therapy: Anti-arrhythmic drugs (AAD) and/or beta-adrenergic blocking agents (BB) (Drug)
结局指标
主要结局
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
- 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