REnal SympathetiC Denervation to sUpprEss Tachyarrhythmias in ICD Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 7
- 主要终点
- Time to First Event Requiring ICD Therapy or Incessant VT
研究概览
简要总结
The objective of this trial is to determine the efficacy and safety of adjunctive catheter-based renal sympathetic denervation (RSDN) in the primary prevention of implantable cardioverter defibrillator (ICD) therapy in patients with ischemic or non-ischemic ventricular dysfunction, who are to receive an ICD for either i) secondary prevention, or ii) primary prevention + inducible ventricular tachycardia (VT) by programmed ventricular stimulation at the time of ICD implantation. These patients will be randomized to ICD alone or ICD + RSDN.
详细描述
Rationale for this Study
Despite significant advances in the management of ventricular arrhythmias through the use of ICD therapy, anti-arrhythmic drugs (AADs), and catheter-based ablation strategies, considerable challenges remain. The optimal method for the prevention of ICD shocks 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. 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 primary prevention of ICD therapy in patients with ischemic or non-ischemic ventricular dysfunction. Also of note, there is data suggesting that RSDN may even decrease the rate of supraventricular arrhythmias such as atrial fibrillation. Thus, RESCUE will specifically evaluate the safety and efficacy of RSDN in the prevention of ICD therapy in patients with ventricular dysfunction who are to receive an ICD for either secondary prevention, or primary prevention if they have inducible VT by programmed ventricular stimulation at the time of ICD implantation.
Description of Procedures
Screening:
To take part in this study, you must meet all study requirements. The screening visit tests and procedures are done to see if you are eligible to be in the study. The study doctor will review these with you and let you know if you qualify. The study doctor will make a final decision about your possible study qualification.
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 85 Years（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, etc.)
- •Planned for ICD implantation for:
- •i. Secondary prevention (eg: VT/VF arrest, sustained VT, syncope/inducible VT)
- •ii. Primary prevention + inducible MMVT during induction via ICD lead testing
- •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
- •Patient taking a Class I or III antiarrhythmic drug.
- •Planned to undergo a cardiac VT ablation procedure
- •NYHA Class IV Congestive Heart Failure
- •MI within 30 days
- •Known renovascular abnormalities that would preclude RSDN (eg, renal artery stenosis, previous renal artery stenting or angioplasty)
- •Baseline orthostatic hypotension
- •End stage renal failure on dialysis
- •Life expectancy <1 year for any medical condition
- •Known pregnancy or positive β-HCG within 7 days of procedure.
- •Coronary Artery Bypass Graft (CABG) within 30 days of the procedure
结局指标
主要结局
Time to First Event Requiring ICD Therapy or Incessant VT
时间窗: 24 months
The primary endpoint of this study is the time to first event requiring implantable cardioverter defibrillator (ICD) therapy or Incessant VT. (Ventricular tachycardia (VT) occurring below the ICD rate cut-off); this will be assessed in the on-treatment patient cohort. An event requiring ICD therapy is defined as an anti-tachycardia pacing (ATP) or shock therapy for ventricular tachycardia or fibrillation.
次要结局
- All-Cause Mortality(24 months)
- BUN Measurements(baseline, 6 months, 12 months, 24 months)
- Procedure Related Adverse Events(24 months)
- Number of Participants With Orthostatic Hypotension(24 months)
- Number of Occurrences of Inappropriate ICD Therapy(24 months)
- Number of Hospitalizations for Cardiovascular Causes(24 months)
- Number of Episodes of Total VT Burden(24 months)
- Number of Occurrence of ICD Storm(24 months)
- Number of Participants With Major Complication(average 30 days)
- Number of Occurrences of Appropriate ICD Therapy(24 months)
- Creatinine Measurements(baseline, 6 months, 12 months, 24 months)
研究者
Vivek Reddy
Director Cardiac Arrhythmia Service, Professor of Medicine
Icahn School of Medicine at Mount Sinai