NL-OMON54426已完成不适用
Cryoablation for Monomorphic Ventricular Tachycardia - CryoCure VT
Adagio Medical0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •IC 1 Male or female the ages of >= 18 years
- •IC 2 Eligible for a catheter ablation due to Ischemic and/or non-ischemic
- •recurrent symptomatic sustained monomorphic Ventricular Tachycardia also
- •defined as having a similar QRS configuration from beat to beat.
- •IC 3 Has or will be receiving an ICD prior to hospital discharge post procedure.
- •IC 4 Refractory to at least one AAD (Refractory is defined as an AAD not able
- •to treat the arrhythmia satisfactorily or induces unwanted side effects).
- •IC 5 Subject has LVEF > 20%, confirmed by echo or comparable technique in the
- •previous 3 months or during baseline evaluation
- •IC 6 Willingness, ability, and commitment to participate in baseline and
- •follow-up evaluations for the full length of the study
- •IC 7 Willingness and ability to give an informed consent
排除标准
- •EC 1 Any known objective contraindication to ventricular tachycardia ablation,
- •TEE, or anticoagulation, including but not limited to the identification of any
- •cardiac thrombus or evidence of sepsis
- •EC 2 Any duration of continuous arrythmia that is not monomorphic ventricular
- •tachycardia. Multiple monomorphic tachycardia is acceptable, but polymorphic VT
- •EC 3 Any VT ablation within 4 weeks prior to enrollment
- •EC 4 More than one prior (>4 weeks) Ventricular Tachycardia ablation or prior
- •surgical treatment for ventricular tachycardia
- •EC 5 Ventricular tachycardia secondary to electrolyte imbalance, active thyroid
- •disease, or any other reversible or non-cardiac cause
- •EC 6 Structural heart disease as described below:
- •a. Class IV heart failure
- •b. Aortic aneurysm
- •c. Previous cardiac surgery or percutaneous coronary intervention within 60
- •days prior to the procedure
- •d. Interatrial baffle, closure device, patch, or PFO occlusion device
- •e. IVC filter
- •f. Coronary artery bypass graft (CABG) procedure within six (6) months prior
- •to the ablation procedure
- •g. Severe Mitral or Aortic insufficiency or stenosis based on most recent TTE
- •h. Cardiac myxoma
- •i. Significant congenital anomaly
- •j. Recent Myocardial Infarct (MI) or unstable angina, within 60 days prior to
- •the ablation procedure
- •k. Mechanical aortic or mitral valve
- •EC 7 Any previous history of cryoglobulinemia
- •EC 8 History of blood clotting or bleeding disease
- •EC 9 Any prior history of documented cerebral vascular accident (CVA), TIA or
- •systemic embolism (excluding a post-operative Deep Vein Thrombosis, DVT),
- •within 6 months prior to the ablation procedure.
- •EC 10 Breastfeeding, pregnant, or anticipated pregnancy during study follow-up
- •EC 11 Current enrollment in any other study protocol where testing or results
- •from that study may interfere with the procedure or outcome measurements for
- •EC 12 Any other condition that, in the judgment of the investigator, makes the
- •patient a poor candidate for this procedure, the study or compliance with the
- •protocol (includes vulnerable patient population, mental illness, addictive
- •disease, candidate for heart transplantation, patient with ventricular assist
- •device, or terminal illness with a life expectancy less than 12 months)
研究者
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