跳至主要内容
临床试验/NCT02780947
NCT02780947Unknown不适用

Prophylactic Substrate Ablation in Post-myocardial Patients Undergoing Defibrillator Implantation.

Spyridon Deftereos0 个研究点目标入组 40 人开始时间: 2016年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
40
主要终点
Appropriate ICD activation therapies

研究概览

简要总结

Prophylactic substrate ablation in post-MI patients undergoing defibrillator implantation reduces appropriate defibrillator therapies.

详细描述

Background In patients with Ventricular Tachycardia (VT) and structural heart disease, the Implanted Cardioverter Defibrillator (ICD), provides a significant protection against the risk of sudden death, however it does not prevent arrhythmia recurrences [1-7]. ICD therapies, especially shocks, pose several risks, including decreased quality of life, increased mortality among patients who suffer ICD shock compared with patients who do not and clinically significant anxiety and depression as a result of recurrent ICD shocks, which has been found to occur in more than 50% of patients [8-12]. Furthermore, ICD implantation has been found not to protect against sudden cardiac death in 3-7% of patients [13].

The benefit of novel ICD programming in reducing inappropriate ICD therapy and mortality was demonstrated in Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy (MADIT-RIT) [14]. Catheter ablation has been considered a plausible curative therapy for VT prevention, especially in patients with VT episodes [15]. The Substrate Mapping and Ablation in Sinus Rhythm to Halt Ventricular Tachycardia (SMASH-VT) and the Ventricular Tachycardia Ablation in Coronary Heart Disease (VTACH) found that prophylactic catheter ablation reduces the incidence of appropriate ICD therapy in patients who had undergone ICD implantation as a means of secondary prevention and had a history of myocardial infarction (MI) [16,17]. It was also shown in a small retrospective study that prophylactic catheter ablation for induced VT reduced the incidence of appropriate ICD therapy in primary prevention post-MI patients [18].

Aim of the study - Statement of Hypothesis Prophylactic substrate ablation in post-MI patients undergoing defibrillator implantation reduces appropriate defibrillator therapies.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Post-MI patients eligible for ICD implantation in the setting of primary prevention

排除标准

  • •NYHA IV or ambulatory NYHA IV
  • •Acute coronary syndrome in the last 40 days
  • •Stable angina not eligible to revascularization
  • •Revascularization in the last 3 months (except MI)
  • •Antiarrhythmic therapy other than b-blockers
  • •GFR<30ml/min/1.73m2
  • •Systematic illnesses

研究组 & 干预措施

Prophylactic substrate ablation group

Active Comparator

Prophylactic substrate ablation group will undergo substrate mapping and ventricular tachycardia substrate ablation

干预措施: Ventricular tachycardia substrate ablation (Procedure)

Control group

No Intervention

Control group will undergo substrate mapping

结局指标

主要结局

Appropriate ICD activation therapies

时间窗: Within 3 years after ICD implantation

All post-MI patients will undergo ICD implantation and electroanatomical substrate mapping of the left ventricle. Half patients will also undergo prophylactic VT ablation aiming to late and early potentials elimination. Post-MI patients who underwent ICD implantation in the setting of primary prevention and prophylactic substrate ablation will have significant less appropriate ICD therapies.

次要结局

未报告次要终点

研究者

发起方
Spyridon Deftereos
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Spyridon Deftereos

Associate Professor of Cardiology

National and Kapodistrian University of Athens

相似试验

已完成
不适用
Impact of PREVENTIVE Substrate Ablation of Coronary Chronic Total Occlusion on Implantable cardioVerTer-Defibrillator InterventionsIschemic CardiomyopathyVentricular Tachycardia
NCT03421834University Medical Centre Ljubljana60
Unknown
不适用
Intra-aortic Balloon Counterpulsation in Patients Undergoing Cardiac SurgeryDysfunction Following Cardiac Surgery Postoperative
NCT02143544University of Sao Paulo180
招募中
不适用
DAPA (Defibrillator After Primary Angioplasty) ¡V Randomized Trial.primary angioplasty for acute MI within 30-60 days with at least one of the following criteria:<br /> 1) TIMI flow after PCI less than 3<br /> 2) left ventricular ejection (LVEF) lower than 30% as measured within 4 days after hospital admission.
NL-OMON28488A.R. Ramdat Misier, MD, PhD, Zwolle, The NetherlandsJ.P. Ottervanger MD, PhD, Zwolle, The NetherlandsProf. M.J. Schalij MD, PhD, Leiden, The NetherlandsProf. F. Zijlstra MD, PhD, Groningen, The NetherlandsE.F.D. Wever MD, PhD, Nieuwegein, The NetherlandsM.J. de Boer, MD, PhD (Zwolle, The Netherlands)W. Beukema, MD (Zwolle, The Netherlands)L. van Erven, MD, PhD (Leiden, The Netherlands)I.C. van Gelder, MD, PhD (Groningen, The Netherlands)700
终止
不适用
Ablation for ICD Intervention Reduction in Patients With CADImplantable Cardioverter-DefibrillatorVentricular TachycardiaCoronary Artery Disease
NCT00481377National Institute of Cardiology, Warsaw, Poland200
撤回
不适用
Atrial Fibrillation Prevention in Post Coronary Artery Bypass Graft Surgery With Cryoablation for Ganglionic PlexiComplication of Coronary Artery Bypass GraftAtrial Fibrillation
NCT02035163Yong Seog Oh