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临床试验/NCT03531502
NCT03531502终止不适用

Initial Management of Patients Receiving a Single Shock (IMPRESS)

Saint Luke's Health System1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年4月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
30
试验地点
1
主要终点
ICD Shocks

研究概览

简要总结

The goal of this study is to determine the optimal treatment for patients who receive a single shock from their implantable cardioverter defibrillator (ICD). All participants in this study will be fitted with a special electrode vest to detect the origin of heart rhythm abnormalities and then they will undergo a procedure called Non-Invasive Programmed Stimulation (NIPS). This procedure involves sedating a participants with anesthesia and then using the participant's own ICD to try to stimulate the heart to go into ventricular tachycardia. If this procedure is unable to induce the participant into ventricular tachycardia, then the participant will just be managed with usual care and will not be placed on any additional medications and will not undergo an ablation. However, if the NIPS induces the ventricular tachycardia, the electrode vest will be used to determine the origin of the abnormal heart rhythm inside the heart. After a successful NIPS procedure, the participants will be randomly assigned to either be placed on medication therapy or undergo catheter ablation. The outcomes from all three groups will be compared and the researchers hope to better understand which participants are most likely to benefit from watchful waiting versus medication versus catheter ablation.

详细描述

Patients with a history of ventricular tachycardia requiring defibrillation or who are at risk for developing ventricular tachycardia will undergo placement of an implantable cardioverter defibrillator (ICD) for purposes of prevention of sudden cardiac arrest. While the ICD is lifesaving, if a patient receives a shock from their ICD it is painful and the entire experience is very traumatic. Traditionally, the management of these patients who receive a single shock from their ICD is variable because it is not known if the patient will continue to experience further shocks or not. Some physicians will initiate antiarrhythmic medical therapy after only a single shock, whereas others will wait until the patient has recurrent ICD shocks before initiating therapy. All patients should be counseled to not drive for 6 months following a shock. Ventricular tachycardia ablation, a procedure involving placing catheters from the groin into the chambers of the heart to isolate the source of ventricular tachycardia and eliminate these foci through delivery of radiofrequency energy, is typically reserved for patients with multiple recurrent cases of ventricular tachycardia. While some studies have shown that ventricular tachycardia ablations can be done safely at an earlier course of the disease and this procedure has been demonstrated to reduce further ICD shocks, this practice is not commonplace.

Patients who undergo a ventricular tachycardia ablation procedure, will initially have catheters placed into the ventricular chambers of the heart and these catheters will be used to stimulate the heart in an attempt to induce the ventricular tachycardia, a process known as programmed stimulation. One major limitation of a ventricular tachycardia ablation procedure is the need to be able to induce the ventricular tachycardia rhythm via programmed stimulation. If this rhythm cannot be induced then it is very difficult to perform the ventricular tachycardia ablation procedure. Non-invasive programmed stimulation (NIPS) is a means of performing programmed stimulation using the patient's own ICD and does not involve placing catheters into the heart.

Aim: The aim of this study is to investigate if non-invasive programmed stimulation (NIPS) can be used to risk stratify patients determine if earlier intervention with either antiarrhythmic medications or ablation in patients with recurrent ventricular tachycardia that received ICD shocks would help decrease further ICD shocks and hospitalizations for ventricular arrhythmias.

Primary hypothesis: Patients receiving a single ICD shock for ventricular tachycardia who undergo a non-invasive programmed stimulation (NIPS) that fails to induce any sustained ventricular tachycardia, are at low likelihood of experiencing recurrent ICD shocks within the next year.

Secondary hypothesis: For patients receiving a single ICD shock for ventricular tachycardia who undergo non-invasive programmed stimulation (NIPS) that induces a sustained, monomorphic ventricular tachycardia rhythm, the performance of ventricular tachycardia ablation will reduce the incidence of recurrent ICD shocks within the next year, as compared to antiarrhythmic therapy alone.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •18-80 years old, both males and females
  • •Single or dual chamber ICD or BiVentricular ICD in situ
  • •Ischemic or non-ischemic cardiomyopathy
  • •Receive a single shock from their ICD for monomorphic ventricular tachycardia

排除标准

  • •ICD shock for polymorphic VT/VF or inappropriate shock
  • •Previous ventricular tachycardia ablation within 1 year
  • •NYHA Class IV heart failure or current inotrope therapy
  • •Ventricular tachycardia storm
  • •Listed for heart transplant or LVAD
  • •Pregnant as determined by urine pregnancy test prior to NIPS

研究组 & 干预措施

Standard medical therapy

Active Comparator

Patients who have a positive NIPS study and are randomized to the medical therapy arm will either be initiated on antiarrhythmic therapy or will have their antiarrhythmic therapy intensified. All medication therapy is considered usual standard therapy.

干预措施: Standard Medical Therapy (Other)

Standard medical therapy

Active Comparator

Patients who have a positive NIPS study and are randomized to the medical therapy arm will either be initiated on antiarrhythmic therapy or will have their antiarrhythmic therapy intensified. All medication therapy is considered usual standard therapy.

干预措施: Non-Invasive Programmed Stimulation (NIPS) (Procedure)

Ventricular Tachycardia Ablation

Experimental

Patients who have a positive NIPS study and are randomized to the ablation arm will undergo ventricular tachycardia ablation procedure guided by CardioInsight.

干预措施: Ventricular Tachycardia Ablation (Procedure)

Ventricular Tachycardia Ablation

Experimental

Patients who have a positive NIPS study and are randomized to the ablation arm will undergo ventricular tachycardia ablation procedure guided by CardioInsight.

干预措施: Non-Invasive Programmed Stimulation (NIPS) (Procedure)

Negative NIPS/Non-intervention

Other

Patients who had a negative NIPS study will not be assigned to a treatment group and will be followed according to standard of care.

干预措施: Non-Invasive Programmed Stimulation (NIPS) (Procedure)

结局指标

主要结局

ICD Shocks

时间窗: 12 months

Number of recurrent ICD shocks

次要结局

  • Total Mortality(12 months)
  • Hospitalizations(12 months)
  • Modification of antiarrythmic medication(12 months)
  • ATP Therapy as recorded by ICD(12 months)
  • Non-sustained VT(12 months)
  • Repeat ablation(12 months)
  • Initiation of antiarrythmic medication(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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