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临床试验/NCT02072707
NCT02072707已完成不适用

Prospective and Randomized Study to Evaluate Efficacy and Safety of Epicardial Ventricular Tachycardia Ablation Using Contact Force Sensor Irrigated Tip Catheter - Pilot Study

University of Sao Paulo General Hospital2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Efficacy of epicardial ablation

研究概览

简要总结

The investigators hypothesized that combined endocardial and epicardial VT ablation using contact sensor irrigated catheter is safe and achieves a lower recurrence rate than endocardial only ablation in ischemic and non-ischemic patients, for this the investigators will randomize 20 patients in two groups, one with endocardial only ablation and other with combined endocardial and epicardial ablation.

详细描述

Pilot Study Design The investigators will select 20 ischemic or non-ischemic cardiomyopathy patients with scar related Ventricular tachycardia with indication of VT ablation. After informed consent, these patients will be randomized to endocardial only (Control Group) or combined endocardial and epicardial ablation (Treatment Group).

Inclusion Criteria Patients with ischemic and non-ischemic cardiomyopathy and recurrent sustained monomorphic VT requiring cardioversion or antiarrhythmic drug administration with ≥4 episodes in the previous 6 months despite an ICD or antiarrhythmic drug therapy. Patients without ICD were eligible after 2 episodes of sustained VT.

Exclusion Criteria Creatinine level >2.5mg/dL; LV ejection fraction <10%; NYHA Class IV; mobile thrombus on LV; absence of vascular access to the LV; life-expectancy of less than 12 months; previous open-chest cardiac surgical procedure; unstable angina; myocardial infarction in the last 2 months; severe aortic stenosis; severe mitral regurgitation secondary to leaflet or chordae rupture; pregnancy and age of less than 18 years old.

Ablation Technique In the patients randomized for combined epicardial and endocardial ablation, subxyphoid puncture will be performed according to previously described technique. Following successful epicardial access on the combined epi and endocardial ablation and following the venous puncture on the endocardial only group, a puncture of femoral artery will be performed. If the patient has peripheral artery disease, the catheter will be positioned on the left ventricle through transeptal puncture.

Electroanatomic voltage map will be constructed of the endocardial and epicardial surface. After map construction, programmed ventricular stimulation of the apex of the RV with S4 extrastimuli will be performed aiming for VT inducibility. If the induced VT is well tolerated, activation mapping of the VT will be constructed in addition to entrainment mapping. If the VT is not hemodynamically tolerated, it will be reverted either by Burst or electrical cardioversion, than substrate modification in the scar combined with pace-mapping and local abnormal electrograms (late potentials) ablation will be performed. In the patients in the endocardial only group, only the endocardial surface of the right or left ventricle will be ablated.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with ischemic and non-ischemic cardiomyopathy and recurrent sustained monomorphic VT requiring cardioversion or antiarrhythmic drug administration with ≥4 episodes in the previous 6 months despite an ICD or antiarrhythmic drug therapy.
  • Patients without ICD were eligible after 2 episodes of sustained VT.

排除标准

  • Creatinine level >2.5mg/dL
  • LV ejection fraction <10%
  • NYHA Class IV
  • Mobile thrombus on LV
  • Absence of vascular access to the LV
  • Life-expectancy of less than 12 months
  • Previous open-chest cardiac surgical procedure
  • Unstable angina; myocardial infarction in the last 2 months
  • Severe aortic stenosis
  • Severe mitral regurgitation secondary to leaflet or chordae rupture
  • Pregnancy and age of less than 18 years old.

结局指标

主要结局

Efficacy of epicardial ablation

时间窗: Programed ventricular stimulation performed 5 minutes after complete ablation

We will evaluate if the procedure was succeeded according to reinducibility of ventricular tachycardia. We consider success as follows: (1) Complete Success: prevention of induction of any VT following ablation; (2) Partial Success: prevention of induction of the clinical VT, remaining the induction of at least one non-clinical faster VT; (3) Failure: Remaining the induction of the clinical or initially induced VT.

次要结局

  • Safety of epicardial access(24 hours after the procedure)
  • Safety of epicardial ablation using irrigated contact sensor catheter(At the end of the procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mauricio Ibrahim Scanavacca

Arrhythmia Clinical Unit Director

University of Sao Paulo General Hospital

研究点 (2)

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