NCT03845010已完成不适用
Elimination of Ventricular Premature Beats With CaTheter Ablation Versus OPtImal Anti-arrhythmic Drug Treatment
Maatschap Cardiologie Zwolle1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2019年2月12日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Successful therapy
研究概览
简要总结
The ECTOPIA trial is a randomized, multicenter, clinical trial to assess elimination of ventricular premature beats (VPB) with catheter ablation versus optimal anti-arrhythmic drugs (AAD) treatment with flecainide/verapamil or sotalol.
详细描述
The ECTOPIA trial is a randomized, multicenter, clinical trial to assess elimination of VPB with catheter ablation versus optimal AAD treatment with flecainide/verapamil or sotalol. Due to the use of different AAD (with and without beta-blocking abilities) the investigators will be able to explore the secondary objectives. Finally, this study will assess safety of ablation of non-RVOT VPBs and long-term treatment with two different AAD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 76 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients willing and capable to provide written informed consent
- •Patients with frequent symptomatic VPB and/or nonsustained VTs with burden ≥ 5% on 24 hour Holter monitor AND
- •Absence of structural heart disease (excluded by echocardiogram) AND
- •Absence of underlying cardiac ischemia (ruled out by treadmill test, CT coronary arteries, nuclear scintigraphy or coronary angiography) AND
- •Patient is considered an acceptable candidate for catheter ablation treatment with a dominant morphology of VPB/VT origin judged by the treating physician.
- •For those already undergoing treatment, all antiarrhythmic drugs including digitalis must be discontinued during a 2-week washout period before entry to the study
排除标准
- •Age >75 years
- •Previous catheter ablation therapy for VPB/VT
- •Patients with sustained ventricular tachycardia or cardiac channelopathies (e.g. Catecholaminergic polymorphic ventricular tachycardia (CPVT), long- or short QT syndrome, Brugada syndrome)
- •Wolff-parkinson-white (WPW) syndrome
- •Use of medication with risk of QTc prolongation (e.g. antidepressant, antiemetic), except for study medication sotalol.
- •Left ventricular dysfunction (LV ejection fraction <55%)
- •Estimated glomerular filtration rate < 50 ml/min/1.73 m2
- •Hepatic impairment defined by a total bilirubin ≥ 2 times the upper limit (ULN) of normal, or alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) ≥ 3 times ULN at screening
- •Untreated hypo- or hyperthyroidism or electrolyte imbalance
- •Untreated obstructive sleep apnea
- •Patients with history of myocardial infarction or bypass surgery
- •More than grade 1/3 valvular regurgitation and/or significant valve stenosis (moderate or severe)
- •Contraindication for any of the antiarrhythmic drugs used in this study
- •Enrolment in another clinical study
- •Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertile age
- •Mental or physical inability to participate in the study
- •Life expectancy ≤ 12 months
研究组 & 干预措施
Sotalol
Active Comparator
干预措施: Sotalol (Drug)
Flecainide and verapamil
Active Comparator
干预措施: Flecainide and verapamil (Drug)
Catheter ablation
Active Comparator
干预措施: Catheter ablation (Procedure)
结局指标
主要结局
Successful therapy
时间窗: After 3 months
Number of patients reaching succesfull therapy defined as \>80% reduction of of VPB/VT burden after 3 months
次要结局
- VPB/VT burden(3, 6, 12 months after intervention)
- Change in VPB/VT burden(Before the intervention (baseline) and 3, 6, 12 months after intervention)
- The impact in terms of total Quality of Life(3, 6, 12 months after intervention compared to baseline (before intervention))
- Association between number of VPB/hour and heart rate (HR)/hour during 24-hours Holter- monitoring(At baseline)
- Number of pro-arrhythmic effects, (non)-sustained VT or atrial flutter, in AAD arms with frequent visits and use of 24-hour Holter monitoring(3, 6 and 12 months after intervention)
- QTc prolongation (sotalol) and QRS broadening (flecainide) with requiring frequent checks with standard ECG and/or treadmill test(4-6 weeks after first administration of AAD)
- Complication rate of catheter ablation(Procedure and 3, 6 and 12 months after intervention)
- Extended evaluation of left ventricular function with transthoracic echo (TTE) (including global longitudinal strain rate measurement)(Baseline, 6 and 12 months after intervention)
- Absolute and relative difference in VPB/VT burden (%) from baseline, during treatment with sotalol versus treatment with flecainide/verapamil(3, 6 and 12 months after intervention)
- Divide patients in three groups depending on HR dependency of VPB/VT and compare absolute and relative difference in VPB/VT burden (%) from baseline, during treatment with sotalol versus treatment with flecainide/verapamil(3, 6 and 12 months after intervention)
研究者
研究点 (1)
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