NCT03314675终止不适用
Assessment of Pacing Stimulus Conduction and Latency Measurements in CRT-D Patients
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 12
- 主要终点
- Rate of patients with LV latency >/= 40ms (stimulus to QRS onset) with respect to the total number of screened patients
研究概览
简要总结
The study is designed to collect data on LV latency in CRT-D patients by the CRT-D and compare measurements to 12-lead ECG data
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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 has been implanted with a CRT-D device by BIOTRONIK at least 4 weeks before enrollment date
- •Patient successfully implanted with a left ventricular lead
- •High likelihood of LV latency ≥ 40 ms
- •LV lead in lateral or postero-lateral position in the coronary venous system
- •Patient is able to understand the nature of the clinical investigation
- •Patient is willing to undergo the required measurements at the investigation site
- •Patient provides written informed consent
- •Age ≥ 18 years
排除标准
- •Patients with irregular ventricular rhythm due to atrial tachycardia
- •Pregnant or breast-feeding women
- •Participation in an interventional clinical investigation
研究组 & 干预措施
CRT-D Measurements
Other
Pre-specified measurements and additional follow-ups
干预措施: BIOTRONIK CRT-D (Device)
结局指标
主要结局
Rate of patients with LV latency >/= 40ms (stimulus to QRS onset) with respect to the total number of screened patients
时间窗: 1 day
次要结局
- Device-base measured LV latency in the LV IEGM channel and Far Field channel(1 day)
- 12-lead ECG-measured LV latency in the channel with earliest QRS onset(1 day)
- Device-based measured latency intervals (stimulus to electrogram peak and end) in the LV IEGM channel and the Far Field channel(1 day)
- 12-lead ECG-measured latency intervals(1 day)
研究者
研究点 (12)
Loading locations...
相似试验
已完成
不适用
Evaluation of Left Ventricular (LV) Lead Positioning Using MediGuideHeart FailureNCT01917266Abbott Medical Devices40
Unknown
1 期
Mitral Insufficiency Reduction With Biventricular PacingMitral RegurgitationNCT01242397Trinity Medical Center, Illinois50
已完成
不适用
Evaluation of Left Ventricular Autothreshold, Phase TwoHeart FailureNCT01242722Boston Scientific Corporation100
已完成
不适用
Cardiac Resynchronization Therapy (CRT) Based Heart Failure Monitoring StudyHeart FailureNCT00632372Abbott Medical Devices8
招募中
不适用
ConTempoRary Cardiac Stimulation in Clinical practicE: lEft, BivEntriculAr, Right, and conDuction System PacingArrhythmias, CardiacReduced Systolic FunctionBradyarrhythmiaVentricular DysfunctionVentricular FibrillationVentricular ArrythmiaAtrioventricular Nodal DiseaseAtrioventricular Conduction DefectsAtrial FibrillationAtrioventricular BlockAtrioventricular Block CompleteAtrioventricular Block IncompleteAtrioventricular Junctional RhythmBundle-Branch BlockLeft Bundle-Branch BlockHeart Failure, SystolicBlock, HeartBlock, FascicularBlock Branch Bundle LeftArrhythmic BlockHeart Failure，CongestiveHeart ArrhythmiaVentricular TachycardiaMobitz BlockAtrioventricular BlockNCT06324682University Hospital of Ferrara8,400