REnal Sympathetic dEnervaTion as an a Adjunct to Catheter-based VT Ablation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Freedom From First Event Requiring ICD Therapy
研究概览
简要总结
Despite significant advances in the management of ventricular arrhythmias through the use of ICD therapy, AADs, and catheter-based ablation strategies, considerable challenges remain. The optimal method for the prevention of recurrent VT following catheter ablation remains unclear. RSDN may be an effective tool for preventing ventricular arrhythmias, and associated ICD therapies, by reducing central sympathetic tone, catecholamine levels, and the renin-angiotensin- aldosterone system and promoting ventricular remodeling. Although RSDN has been shown to reduce the recurrence of VT in a case report of 2 patients suffering from electrical storm, to date no large prospective randomized study has evaluated the impact of RSDN in the prevention of recurrent VT in patients following catheter ablation of VT with ischemic or non-ischemic ventricular dysfunction. This study will specifically evaluate the safety and efficacy of adjunctive RSDN in the prevention of ICD therapy in patients with ischemic or non-ischemic ventricular dysfunction who are to receive a catheter-based VT ablation.
详细描述
The goal of this trial is to test the impact of catheter-based renal sympathetic denervation (RSDN) as an adjunctive treatment for patients with either ischemic or non-ischemic cardiomyopathy undergoing catheter ablation of ventricular tachycardia (VT). The proposed study is a prospective, multicenter, randomized control trial. Patients undergoing VT ablation will be randomized to either VT ablation alone or VT ablation + RSDN.
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
- Single (Participant)
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
- •≥ 18 years of age
- •Structural heart disease (post-MI, dilated cardiomyopathy, sarcoid myopathy, hypertrophic cardiomyopathy, chagas-related cardiomyopathy, etc.)
- •Planned for catheter-based ablation of VT
- •All patients will have an existing ICD
- •Accessibility of renal vasculature (determined by renal angiography)
- •Ability to understand the requirements of the study
- •Willingness to adhere to study restrictions and comply with all post- procedural follow-up requirements
排除标准
- •MI or CVA within 30 days
- •Coronary Artery Bypass Graft (CABG) within 30 days of this procedure
- •Known renovascular abnormalities that would preclude RSDN (eg, renal artery stenosis)
- •GFR <30 ml/min (unless receiving dialysis)
- •Life expectancy <1 year for any medical condition
- •Any condition resulting in a contraindication to anticoagulation (e.g. GI bleeding)
- •Inability to give informed consent
- •Known pregnancy or positive -HCG within 7 days of procedure.
研究组 & 干预措施
Renal sympathetic denervation
Catheter-based Renal Sympathetic Denervation Ablation Arm
干预措施: Renal sympathetic denervation (Device)
VT ablation alone
No further therapy in addition to VT ablation
干预措施: VT ablation alone (Device)
结局指标
主要结局
Freedom From First Event Requiring ICD Therapy
时间窗: 24 months
Probability of freedom from first event requiring ICD therapy at 12 months and at 24 months
次要结局
- Number of Appropriate ICD Shocks for Ventricular Arrhythmia(at 24 months)
- Number of Inappropriate ICD Therapy(at 24 months)
- All ICD Therapies (Appropriate + Inappropriate)(24 months)
- Differences in BUN/Creatinine Measurements(baseline and 12 months)
- Change in LV Size(baseline and 12 months)
- Number of Participants With Mortality, ICD Storm and Incessant VT(24 months)
- Number of Participants With Hospitalizations for Cardiovascular Causes(24 months)
- Number of Episodes of Total VT Burden(at 24 months)
- Change in Brain Natriuretic Peptide (BNP)(at baseline and at 12 months)
- Number of Procedure-related Adverse Events(24 months)
- Changes in Mean Arterial Pressure(baseline and 24 months)
- Number of Participants With Orthostatic Hypertension(24 months)
- Number of Participants With Other Complications(at 24 months)
- Number of Occurrences of Major Complication Rate(30 days)
- Procedure Time(during procedure)
- Number of Participants With All-Cause Mortality(24 months)
- Number of Participants With Occurrences of ICD Storm(24 months)
研究者
Vivek Reddy
Director Cardiac Arrhythmia Service, Professor of Medicine
Icahn School of Medicine at Mount Sinai