The Effect of Cardiac Pacing Leads on Tricuspid Regurgitation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 119
- 试验地点
- 2
- 主要终点
- Decrease in Tricuspid Regurgitation using smaller diameter lead and placing the lead on the proximal septum.
研究概览
简要总结
The effect of cardiac pacing leads on tricuspid regurgitation is unclear. This study will determine whether using a smaller diameter leads and an alternate position in the ventricle, the proximal septum, will reduce tricuspid regurgitation than larger leads placed in the apex.
详细描述
Leads are commonly placed in the right ventricular apex. It is not known whether placing similar leads higher on the septum where there will be less redundancy or pressure on the septal leaflet will change the extent and severity of tricuspid regurgitation following pacemaker/ICD implantation. Data has shown that right ventricular pacing can give rise to right ventricular dysfunction, which in turn may give rise to enlargement of the right ventricle and cause tricuspid regurgitation.
The study will answer the clinically relevant questions on device lead-related tricuspid regurgitation.
This study is a single center prospective study at the Mayo Clinic, Rochester. The study will enroll 200 eligible subjects and follow for 12 months. 50 pacemaker subjects will be randomized to right ventricular apex pacing 50 pacemaker subjects will be randomized to right ventricular septum pacing 50 pacemaker subjects will be randomized to left ventricular pacing via coronary sinus 50 ICD subjects will be enrolled with right ventricular apex pacing.
A baseline heart failure assessment and Two Dimensional echocardiography will be performed before device implant.
A Two Dimensional echo will be performed 24 hours after device implant. If significance TR is present a Three Dimensional echo will be performed. At 12 months post implant heart failure assessment and Two Dimensional echo will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of either sex
- •Patient is recommended to receive a pacemaker or an ICD
- •Provide informed consent
排除标准
- •Pregnant or breastfeeding women
- •Congenital heart disease
- •Pre-existing moderate or severe TR
- •An existing pacemaker or defibrillator
- •Pulmonary hypertension
- •Pacemaker dependence
- •Unable to give informed consent
- •Not feasible for patient to be followed up at Mayo Clinic
- •Acute myocardial infarction within 7 days
结局指标
主要结局
Decrease in Tricuspid Regurgitation using smaller diameter lead and placing the lead on the proximal septum.
时间窗: 12 months
次要结局
- Left Ventricular lead placement will be associated with least amount of TR because of avoiding crossing the tricuspid valve and by virtue of relatively more synchronous ventricular contractions.(12 months)
研究者
Yong-Mei Cha
Cardiovascular Division
Mayo Clinic