Cryoablation for Monomorphic Ventricular Tachycardia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 64
- 试验地点
- 8
- 主要终点
- Primary Endpoint for Clinical Performance
研究概览
简要总结
A prospective, single-arm, multi-center, pre-market, clinical study designed to provide safety and performance data regarding the use of the Adagio Medical VT Cryoablation System in the treatment of ventricular tachycardia.
详细描述
Study subjects will include patients who experience recurrent monomorphic VT and are scheduled for an endocardial VT ablation. Study subjects have or will have an Implantable Cardioverter Defibrillator (ICD) prior to hospital discharge following the cryoablation procedure.
A VT ablation procedure is performed by finding the abnormal ventricular heart tissue that is causing the VT and applying energy with an ablation catheter to the area. The goal is to apply energy to create a scar or destroy the tissue that causes the VT, such that VT is no longer present or inducible.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
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 is not.
- •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:
- •Class IV heart failure
- •Aortic aneurysm
- •Previous cardiac surgery or percutaneous coronary intervention within 60 days prior to the procedure
- •Interatrial baffle, closure device, patch, or PFO occlusion device
- •Coronary artery bypass graft (CABG) procedure within six (6) months prior to the ablation procedure
- •Severe Mitral or Aortic insufficiency or stenosis based on most recent TTE
- •Cardiac myxoma
- •Significant congenital anomaly
- •Recent Myocardial Infarct (MI) or unstable angina, within 60 days prior to the ablation procedure
- •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 this study
- •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)
结局指标
主要结局
Primary Endpoint for Clinical Performance
时间窗: 6 month post cryoablation procedure
an analysis of the proportion of patients receiving a single cryoablation procedure with freedom from ventricular tachycardia lasting longer than 30 seconds or appropriate ICD intervention until the end of the 6 month follow up period.
Primary Endpoint for Safety
时间窗: during and 30 days post cryoablation procedure
An analysis of the proportion of subjects who are free from definite or probable device/procedure related Major Adverse Events (MAEs) that occur during or within 30 days following the cryoablation procedure
Primary Endpoint for Procedure Performance
时间窗: at the end of the cryoablation procedure
an analysis of the proportion of subjects with non-inducible clinical monomorphic VT at the conclusion of the initial cryoablation procedure
次要结局
- Descriptive Statistical Outcome - Hospitalization(12 months post cryoablation procedure)
- Performance - VT burden(6 and 12 months post cryoablation procedure)
- Safety - freedom from procedure or device related SAE(12 months post cryoablation procedure)
- Performance - non-inducible sustained monomorphic VT(at the end of the cryoablation procedure)
- Performance - freedom from VT at 12-M off AADs(12 months post cryoablation procedure)
- Performance - freedom from VT at 12-M on previously failed AADs(12 months post cryoablation procedure)
- Descriptive Statistical Outcome - procedure time(at the end of the cryoablation procedure)
- Descriptive Statistical Outcome - ICD shocks(12 months post cryoablation procedure)
- Descriptive Statistical Outcome - ablation strategies(at the end of the cryoablation procedure)
- Descriptive Statistical Outcome - cryoablation lesions(at the end of the cryoablation procedure)
- Descriptive Statistical Outcome - ablation time(at the end of the cryoablation procedure)
- Descriptive Statistical Outcome - AADs use(12 months post cryoablation procedure)
- Descriptive Statistical Outcome - fluoroscopy time(at the end of the cryoablation procedure)
- Descriptive Statistical Outcome - inducible VTs(at the end of the cryoablation procedure)