Conduction System Pacing Optimized Therapy Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 24
- 主要终点
- Electrical Synchronization Response
研究概览
简要总结
The purpose of the CSPOT study is to determine the best mode of cardiac resynchronization therapy (CRT) pacing for different populations of CRT patients, comparing traditional biventricular or left ventricular pacing (BiV), conduction system pacing (CSP)-only, and conduction system pacing optimized therapy (CSPOT) also known as a combination of conduction system pacing (CSP) and left ventricular (LV) pacing. Additionally, safety of the system will be assessed.
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
- •Patient is willing and able to provide written informed consent
- •Subject is at least 18 years of age
- •Patient is willing and able to comply with the protocol, including follow-up visits
- •The patient's medical records must be accessible by the enrolling site over the follow-up period
- •Standard CRT-D or CRT-P indications, with a preference for IVCD and non-LBBB patients, where LBBB is defined according to Strauss criteria.
- •De-novo CRT implant, including upgrade from pacemaker or ICD
排除标准
- •Subject has persistent or permanent AF (Atrial Fibrillation)/AFL (Atrial Flutter)
- •Subject has 2nd or 3rd degree AV (Atrioventricular) Block
- •Subject has RBBB with no additional conduction block
- •Subject has intrinsic (non-paced) QRS width less than or equal to 120 ms
- •Subject experienced MI within 40 days prior to enrollment
- •Subject underwent valve surgery, within 90 days prior to enrollment
- •Subject is post heart transplantation or is actively listed on the transplantation list
- •Subject is implanted with a LV assist device
- •Subject has severe renal disease
- •Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure
- •Subject has severe aortic stenosis (with a valve area of <1.0 cm or significant valve disease expected to be operated within study period)
- •Subject has severe aortic calcification or severe peripheral arterial disease
- •Subject has complex and uncorrected congenital heart disease
- •Subject has mechanical heart valve
- •Pregnant or breastfeeding woman (pregnancy test required for woman of child-bearing potential and who are not on a reliable form of birth regulation method or abstinence)
- •Subject is enrolled in another study that could confound the results of this study without documented pre-approval from Medtronic study manager
结局指标
主要结局
Electrical Synchronization Response
时间窗: At implant during acute protocol
Standard Deviation of Activation Times (SDAT) is a measurement of dyssynchrony, taken by the ECG belt. As described in the SDAT Acute Protocol (below) and intervention sections, percent change in SDAT from AV-only pacing was calculated for each patient-pacing configuration combination over the 5 AV delays. Within each patient the difference between CSPOT SDAT and CSP SDAT and the difference between CSPOT SDAT and BiV SDAT were taken. The mean of those differences across patients was calculated along with a 95% confidence interval.
Hemodynamic Response
时间窗: At implant during acute protocol
Left Ventricular (LV) dP/dt max, a measurement of the initial velocity of myocardial contraction. As described in the LV dP/dt max (below) and intervention sections, percent change in LV dP/dt max from AV-only pacing was calculated for each patient-pacing configuration combination over the 5 AV delays. Within each patient the difference between CSPOT SDAT and CSP SDAT and the difference between CSPOT SDAT and BiV SDAT were taken. The mean of those differences across patients was calculated along with a 95% confidence interval.
次要结局
- Left Ventricular Ejection Fraction (LVEF)(Baseline and 6 months)
- Left Ventricular End Systolic Volume (LVESV)(Baseline and 6 months)
- Clinical Composite Score (CCS)(6 months)
- Absolute Percent Change in SDAT by QRS Subgroup(At Implant during acute protocol)
- Absolute Percent Change in SDAT Split by Subjects With Pure LBBB and With Other Conduction Disorders(At Implant during acute protocol)
- Absolute Percent Change in SDAT Split by Subjects With Ischemic Cardiomyopathy and Those With Non-Ischemic Cardiomyopathy(At Implant during acute protocol)
- Percent Change in LV dP/dt Max Split by Subjects With Ischemic Cardiomyopathy and Those With Non-Ischemic Cardiomyopathy(At Implant during acute protocol)
- Percent Change in LV dP/dt Max Split by Subjects With Pure Left Bundle Branch Block (LBBB) and With Other Conduction Disorders (NIVCD)(At Implant during acute protocol)
- Improvement in LV dP/dt Max by QRS Subgroup(At Implant during acute protocol)