Feasibility Study of Diaphragm Synchronized Pacing (DSP) Via the Left Inferior Phrenic Vein (LIPV) Approach
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The feasibility of local diaphragm muscle pacing
研究概览
简要总结
Cardiac resynchronization therapy（CRT） benefits a portion of patients, while more patients are not yet indicated to a therapy that mechanically helps the heart systole and/or diastole. Synchronized diaphragmatic pacing may be feasible to induce diaphragm local contraction and recoil that enhance pump function of the heart, thus improve cardiac function and QoL.
This acute, interventional study is conducted in a single site, Renji Hospital, to evaluate the feasibility of diaphragm pacing and assess the beneficial effect of pacing-regulated diaphragm movement to the heart, with 10 cases of sample size and one-week follow-up after discharge.
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
- •Patients aged >=18 yrs;
- •Patients indicated for CRT or CRT-D , planned for LV lead implantation;
- •Patients are willing to participate in the study and provide signed informed consent
排除标准
- •CRT or CRT-D replacement
- •Ischemic heart disease with CABG history
- •Diaphragm dysfunction history
- •Phrenic nerve injury
- •IVC filter history
- •Abdominal surgery history
- •Splenomegaly
- •Pulmonary disease
- •Moderate or severe liver cirrhosis
- •Severe hepatic or renal dysfunction
- •Currently pregnant or planning pregnancy during the study period
- •Patients participate in another study that will confound this study
研究组 & 干预措施
DSP LIPV group
干预措施: DSP (Procedure)
结局指标
主要结局
The feasibility of local diaphragm muscle pacing
时间窗: Acute, during the procedure
To evaluate the success rate of diaphragm pacing and the capability of the electrode to capture the local diaphragm below the cardiac apex, providing a recommendation of venous access and route for the interventional procedure to conduct local electrical stimulation in the diaphragm.
次要结局
- The observation of pacing-regulated diaphragm movement for the determination of local diaphragm capture(Intra-procedure)
- The diameter (or dimension) of the local venous anatomy(Perioperative)
- DSP lead threshold(Intra-procedure)
- Complications of the diaphragmatic synchronized pacing(Perioperative)
研究者
Tianbao Yao
Associate Chief Physician
RenJi Hospital