Triple-site Biventricular Stimulation in the Optimization of Cardiac Resynchronization Therapy (CRT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 28
- 主要终点
- TriV pacing is superior to standard BiV pacing in reversing ventricular modeling as demonstrated by Echo LVESV at 12 months in pts. with non LBBB without increasing the risk of serious events at 30 days.
研究概览
简要总结
Cardiac resynchronization is a recommended therapy for patients with advanced heart failure, under optimized medical treatment with reduced left ventricular ejection fraction and prolonged QRS, nevertheless, still 30% of the population do not respond to standard biventricular implantation.
Non-response can be explained by a combination of factors including sub-optimal patient selection, placement of the pacing lead over a zone of slow conduction, insufficient correction of mechanical dyssynchrony including sub-optimal lead implantation. Few data distinguish true non-responders from patients in which effective resynchronization was not delivered through standard biventricular implantation.
Triple-site cardiac resynchronization pacing (stimulation at three ventricular sites) has been proposed to improve synchrony and thus the response rate in (Cardiac Resynchronisation Therapy) CRT recipients.
详细描述
The frequent failure of CRT in non-Left Bundle Branch Block (non-LBBB) patients is suspected to be due to more complex and heterogeneous forms of electrical/mechanical dyssynchronies needing more complex and individualized pacing configurations to be corrected.
Acute studies during implant show that standard biventricular pacing provides optimal mechanical improvement only in a minority of patients. In a peri-operative echo-guided leads placement procedure most of non-improved patients could be successfully mechanically resynchronized. A significant number of patients required optimized placement of right ventricular (RV) lead and/or triple-site configurations.
These studies led to the hypothesis that more complex and individualized pacing configurations (Triple-site biventricular) might increase the number of responders to CRT.
To assess this hypothesis, this study will be conducted in Class II-ambulatory IV patients indicated for CRT with wide QRS (≥ 140 ms) and non-LBBB. Patients will be randomized in a 1:1 configuration:
- Standard biventricular pacing (1 right ventricular/1 left ventricular (1RV/1LV)) through classical implantation procedure without peri-operative optimization
- Triple-site biventricular pacing with individual optimization of the placement of the third lead by peri-operative echo guidance.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 18 years
- •Stable heart failure with New York Heart Association (NYHA) functional class II, III or ambulatory IV
- •Stable optimized medical regimen according to medical guidelines (No change in heart failure medication for at least 1 month prior to enrollment)
- •Left ventricular ejection fraction (LVEF) ≤ 35%
- •Intrinsic QRS duration ≥ 140 msec
- •Non-typical left bundle branch block (LBBB) morphology on 12-lead surface ECG
- •Signed and dated informed consent
排除标准
- •Typical LBBB according to Strauss criteria
- •Unstable heart failure
- •Permanent or long-lasting persistent Atrial Fibrillation
- •Unstable angina, acute Myocardial Infarction (MI), Coronary Artery Bypass-Grafting (CABG), or Percutaneous Transluminal Coronary Angioplasty (PTCA) within 90 days prior to enrollment (intervention)
- •Conventional pacemaker indication
- •Previous implant with a pacemaker or an Implantable Cardioverter-Defibrillator (ICD)
- •Renal Failure (Glomerular filtration rate (GFR) < 30 ml/min/1.73m2)
- •Pregnant women
- •Already included in another clinical study that could confound the results of this study
- •Life expectancy < 12 months
- •Mechanical heart valve or indication for valve repair or replacement
- •Recent Cerebro-Vascular Accident (CVA) or Transient Ischemic Attack (TIA) (within the previous 3 months)
- •Heart transplant
结局指标
主要结局
TriV pacing is superior to standard BiV pacing in reversing ventricular modeling as demonstrated by Echo LVESV at 12 months in pts. with non LBBB without increasing the risk of serious events at 30 days.
时间窗: 12 months
The efficacy endpoint for this study is the change in LVESV at twelve months post-implant between individually optimized, triple-site biventricular pacing and standard biventricular pacing. LVESV is a standard marker of CRT effectiveness1. Echocardiographic data collected at twelve months follow-up will document the evolution of LVESV as compared to baseline in order to assess reverse ventricular remodeling. The safety endpoint for this study is the rate of all serious procedure and/or device related events reported at thirty days post-implant.
次要结局
- Evaluate serious device related complications at six and twelve months post-procedure.(6 and 12 months)
- Evaluate reverse ventricular remodeling response based on additional echocardiographic measures(6 and 12 months)
- Evaluate mortality and serious heart failure (HF) events during the procedure through discharge and at the different follow-up time-points.(1, 6 and 12 months)
- Evaluate patient's clinical status considering New York Heart Association (NYHA) functional class improvement(6 and 12 months)