Optimization of Coronary Sinus Lead Placement for CRT Delivery in Non-LBBB or Narrow LBBB Patterns Using Multiparametric 82Rubidium PET-CT Scan Analysis and Cardiac CT Venography (RESYNC-PETCT)
RESYNC-PETCT Study - Optimization of Coronary Sinus Lead Placement for CRT Delivery in Non-LBBB or Narrow LBBB Patterns Using Multiparametric 82Rubidium PET-CT Scan Analysis and Cardiac CT Venography
CRT improves outcomes in heart failure patients, but class II candidates (i.e. patients presenting non-LBBB or narrow LBBB patterns) benefit less from this treatment. The RESYNC-PETCT study explores advanced imaging guidance using 82Rubidium PET-CT and cardiac CTV to target coronary sinus lead placement with the aim to improve CRT response in this specific patient population. All genders will be included in this study. However, gender is not considered a variable in this clinical trial.
Patients participating in this study will benefit from an individualized approach to CRT implantation. The nuclear and radiological tests proposed in this research project will imply an additional radiation exposure compared to the standard care. However, the total additional radiation dose will remain below the recommended threshold for clinical trials so that the radiological risks associated to these investigations appear negligible and are counterbalanced by the improvement in LVEF and NYHA expected from a targeted coronary sinus lead positioning.
The objective of the RESYNC-PETCT study is to demonstrate that optimising the coronary sinus lead implantation by using combined data from 82Rubidium PET-CT scan and cardiac CTV reconstruction is a feasible approach to improve the LV electrical and mechanical synchronicity and therefore the clinical response in patients presenting non-LBBB patterns or LBBB patterns with QRS duration < 150ms.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Giulia Domenichini, MD PhD
- 电话号码:+41 21 314 11 11
- 邮箱:giulia.domenichini@chuv.ch
研究联系人备份
- 姓名:Christel C Kamani
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Symptomatic heart failure (NYHA class II, III and IV) despite optimal medical treatment
- LVEF ≤ 35%
- Sinus rhythm
- Non LBBB pattern on 12-lead ECG with QRS > 130 ms
- LBBB pattern on 12-lead ECG with QRS > 130 ms and < 150 ms
- Patient is able to understand the nature of the research project and to provide written informed consent.
- Patient accepts to be informed about incidental findings discovered by 82Rubidium PET-CT scan and cardiac CTV that imply clinical management
Exclusion Criteria:
- Pregnancy (as per standard procedure)
- Age less than 18 years
- Severe chronic kidney disease (Glomerular filtration rate < 30mL/min) contraindicating a cardiac CTV
- Life expectancy of less than 12 months.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Heart failure patients with CRT indications
|
CRT-P/CRT-D implantation
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Feasibility of guided coronary sinus lead placement/Improvement in LVEF ≥ 5% measured by TTE and reduction in NYHA ≥ 1
大体时间:CRT implant day and 3/6 months follow-up
|
CRT implant day and 3/6 months follow-up
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Improvement in mechanical dyssynchrony assessed by phase analysis of 82Rubidium PET-CT scan/Differences in LVEF, mechanical dyssynchrony, and NYHA class among the study patients implanted with a BIV-CRT approach and the study patients stimulated in LBBAP
大体时间:6 months
|
6 months
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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