"Ventricular Tachycardia Ablation Registry". Italian Registry of Substrate Mapping and VT Ablation With the Precision Mapping System and Flexability Catheter.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 312
- 试验地点
- 1
- 主要终点
- Late potential abolition and ventricular tachycardia noninducibility
研究概览
简要总结
Catheter ablation of Ventricular Tachycardias is a well-established approach in clinical practice in patients with Implantable Cardioverter Defibrillator (ICD) implanted. Previous studies have shown a significant reduction in appropriate shocks (~ 20%) and a significant reduction in hospitalizations for cardiovascular reasons (~ 12%) in patients with ischemic heart disease treated with ablation. Recent works have also shown the effectiveness of the ablation procedure using as procedural target the reduction of late potentials. However, actually it is necessary to have an homogenize and accepted mapping scheme in Sinus Rhythm to ablate Ventricular Tachycardias related to scar substrate in patients with:
- Previous MI
- Previous myocarditis
- Arrhythmogenic Right Ventricular Dysplasia (ARVD)
- Idiopathic Dilated Cardiomyopathy (IDCM)
Scope of the registry is to collect data during cardiac mapping in Sinus Rhythm in patients indicated for Ventricular Tachycardia ablation, that will be performed per clinical practice, by using the St. Jude Medical EnSiteTM PrecisionTM mapping system.
The objective of the present registry is: to assess the acute and long-term efficacy of the strategy of substrate abolition (abolishment of complex and late potentials) guided by electroanatomic mapping with Precision software.
详细描述
This is an Italian multicenter, observational, prospective and retrospective registry.
Data will be collected during enrollment/baseline, procedure, pre-discharge and during the follow-up visits according to the standard practice of participating centers, with mandatory visits at 6 and 12 months. Data can also be collected retrospectively, prior informed consent of the patient.
The planned enrollment duration is approximately 24 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Patients with an implanted ICD
- •Patients with indication to Ventricular Tachycardia Ablation procedure, supported by EnSite Precision 3D mapping system (previous MI, myocarditis, ARVD, IDCM)
- •Age 18 years or more
- •Able to provide an informed consent to participate to the registry and available to respect the assessments described in the protocol
排除标准
- •Contraindication to anticoagulants
- •Presence of thrombi
- •Presence of Mitral and Aortic prosthetic valve
- •Recent (<3 months) myocardial infarction or unstable angina or Coronary Artery Bypass
- •Pregnant or nursing
- •Ventricular Tachycardia caused by reversible pathology
- •< 1 Year life expectancy according to the investigator
- •Contraindication to the use of ablation/diagnostic catheters or to cardiac catheterism
结局指标
主要结局
Late potential abolition and ventricular tachycardia noninducibility
时间窗: Intraprocedural
Combined procedural endpoint of late potential (LP) abolition and VT noninducibility (endpoint expected in 50% of cases). LP abolition assessed as % of persistent LP area at remap after ablation, compared to the basal activation map.
Ventricular tachycardia recurrence
时间窗: 12 months
Freedom from Ventricular Tachycardia episodes requiring ICD Intervention (shock or Anti-Tachycardia Pacing)
次要结局
- Procedural parameters(Intraprocedural)
- Complications(12 months)
- Assessment of cardiac mapping system EnSite Precision™ software (St.Jude, now Abbott)(Intraprocedural)
研究者
Paolo Della Bella
MD
IRCCS San Raffaele