MultiPoint Pacing IDE Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 506
- 试验地点
- 98
- 主要终点
- Freedom From System-related Complications Through 9 Months Compared to an Objective Performance Criterion
研究概览
简要总结
This IDE study is a prospective, randomized, double-blind, multi-center clinical study to evaluate the safety and efficacy of patient treatment with MPP compared to patient treatment with standard BiV pacing at 9 months.
The study will be conducted at a maximum of 50 investigational centers located in the United States. A maximum of 506 subjects implanted with the Quadripolar cardiac resynchronization therapy device (CRT-D) system will be enrolled in the study.
详细描述
All subjects will undergo a 2 dimensional Echocardiogram within the 30 days prior to implant, and again at 3, 6 and 9 months post implant. At implant, the final LV pacing configuration is programmed using any one of the 10 available pacing vectors. The paced/sensed atrioventricular (AV) and interventricular (VV) delays may be optimized as per the site's standard of care. Subjects will continue to receive BiV therapy until the 3-month follow-up visit.
At the 3-month visit, responder status between Enrollment and 3 months will be assessed using the Clinical Composite Score (CCS). All subjects that are "Improved" using the definition outlined in the CCS will be grouped together as Responders. All subjects that are "Worsened" or "Unchanged" using the definitions outlined in the CCS will be considered as Non-responders. All subjects will undergo acute measurement of cardiac performance (e.g., Echocardiography) at various MPP combinations compared to BiV pacing. Only subjects with "equal or better" echocardiographic measurements (i.e., EA VTI measurements) with MPP feature on compared to BiV pacing will be randomized in a 1:1 ratio to one of the two arms - BiV arm or MPP arm.
At the 9-month visit, responder status will be evaluated once again using the CCS and compared to the status at 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Meets current clinical indication for implantation of a cardiac resynchronization therapy system for treatment of heart failure or life-threatening ventricular tachyarrhythmia(s)
- •Receiving a new CRT implant or undergoing an upgrade from an existing ICD or pacemaker implant with no prior LV lead placement
- •Have the ability to provide informed consent for study participation and are willing and able to comply with the prescribed follow-up tests and schedule of evaluations
排除标准
- •Have had a recent Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) within 3 months of enrollment
- •Have an existing Class I recalled lead
- •Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate
- •Have a classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 9 months
- •Have permanent atrial fibrillation (AF)
- •Have undergone a cardiac transplantation within 40 days of enrollment
- •Have had a recent myocardial infarction, unstable angina within 40 days or cardiac revascularization within 3 months of implant.
- •Are currently participating in a clinical investigation that includes an active treatment arm
- •Are pregnant or planning to become pregnant during the duration of the study
- •Have a life expectancy of less than 9 months due to any condition
- •Are less than 18 years of age
研究组 & 干预措施
Multi-point pacing arm
MultiPoint Pacing
干预措施: MultiPoint Pacing (Device)
Biventricular arm
Traditional Biventricular Pacing
干预措施: Traditional Biventricular Pacing (Device)
结局指标
主要结局
Freedom From System-related Complications Through 9 Months Compared to an Objective Performance Criterion
时间窗: Implant to 9 months
A system related complication is a complication related to the Quadripolar CRT-D device system which includes pulse generator and leads, as adjudicated by an independent Clinical Events Committee (CEC). All subjects who had an attempted implant or a successful Quadripolar system implant were included in the analysis of this safety endpoint.
Percentage of Non-responders With MPP Compared to Biventricular Pacing
时间窗: 3 months to 9 months
The hypothesis is that the non-response rate to CRT therapy in the MPP therapy arm is not inferior to the non-response rate in the BiV arm between 3 and 9 months post-implant. Responder status was assessed using the Clinical Composite Score (CCS). A patient's CCS was classified as worsened, improved or unchanged based on the definitions below: * Worsened - patient died due to cardiovascular reasons, experienced a HF event, demonstrated worsening in NYHA class, or had worsening of PGA score compared to the last observation * Improved - patient survived without a HF event, and demonstrated either improvement in NYHA class or improvement in PGA score, or both compared to the last observation. * Unchanged - patient was neither improved nor worsened For patients who were responders at the 3-month visit, those who were "Improved" and "Unchanged" between 3 and 9 months were classified as responders, whereas those who were "Worsened" were grouped together as non-responders.
次要结局
未报告次要终点