Effect of Right Ventricular Lead Position on Defibrillation Threshold
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- OhioHealth
- 试验地点
- 2
- 主要终点
- Defibrillator threshold
研究概览
简要总结
The purpose of this study is to determine how the position of the right ventricular (RV) coil of an implantable cardioverter defibrillator (apex versus septum) affects the defibrillation threshold; specifically, can defibrillator threshold be improved by implantation site selection.
详细描述
The investigators propose a prospective, pseudo-randomized study of patients who are electing to undergo implantation of an implantable cardioverter defibrillator (ICD).
There are two locations in the heart in which ICDs are normally implanted: the apex and the septum. The purpose of this study is to determine whether the ICD performs better in one location or the other, as measured by defibrillation threshold. In this study, both locations will be tested in each patient. The final location will be determined by the implanting physician as the location that is best for the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Patient indicates for single-chamber (VR), dual-chamber (DR) or resynchronization CRT-D) implantable defibrillator
- •Left-sided implant
- •Single coil or dual coil (single coil for testing)
- •Age ≥ 18 years of age
- •Ability to consent
- •Medically stable, in the opinion of the implanting physician, to undergo defibrillation safety margin testing
- •Procedure performed under conscious sedation
- •English-speaking
排除标准
- •Patient unable to understand and consent to the procedure on his or her own
- •Pregnant or breastfeeding patients
- •New York Heart Association (NYHA) Class IV
- •Patients with pre-existing RV leads
- •Pacemaker dependent
- •Patient medically unstable to undergo defibrillation testing (e.g., high risk for deep sedation; patients that develop respiratory compromise or hemodynamic instability from the sedation)
- •Patients that require general anesthesia instead of conscious sedation
- •Patients <18 years of age
- •Non-English-speaking
研究组 & 干预措施
Apex First
Patients born in odd-numbered years will receive an implantable cardioverter defibrillator (ICD). Defibrillation threshold determined with the right ventricular lead placed first in the apex and then in the septum. Final lead position will be determined at the discretion of the implanting physician.
干预措施: Implantable Cardioverter Defibrillator (ICD) (Procedure)
Septum First
Patients born in even-numbered years will receive an implantable cardioverter defibrillator (ICD). Defibrillation threshold determined with the right ventricular lead placed first in the septum and then in the apex. Final lead position will be determined at the discretion of the implanting physician
干预措施: Implantable Cardioverter Defibrillator (ICD) (Procedure)
结局指标
主要结局
Defibrillator threshold
时间窗: At the time of each surgery through study completion, or up to 12 months
Defibrillator threshold (DFT) will be determined at the time of implantation for each patient at the apex and the septum. A difference of \>4 joules will be considered clinically significant.
次要结局
- Percentage of patients with improved defibrillation threshold at the septum versus the apex(At the time of each surgery through study completion, or up to 12 months)