MOre REsponse on Cardiac Resynchronization Therapy (CRT) With MultiPoint Pacing (MPP)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5,850
- 试验地点
- 206
- 主要终点
- Percentage of Non-responder Patients Who Converted to Responders
研究概览
简要总结
The purpose of this Clinical investigation is to assess the impact of the Multi Point Pacing (MPP) feature at 12 months in the treatment of patients not responding to standard Cardiac Resynchronization Therapy (CRT) after 6 months.
详细描述
This study is designed as a prospective, randomized, multi-center trial. Data will be collected at enrollment, baseline, implant procedure, patient classification, 6 months and 12 months of follow-up. During the 6-month visit, the patient's response to CRT will be evaluated according to LVESV reduction. Patients with an LVESV reduction of at least 15% will be classified as responders. These patients will terminate their participation in the study and return to the center's standard practice. Patients with an LVESV reduction less than 15% will be classified as non-responders and the MPP feature will be activated according to randomization result and they will be followed until the 12-month visit.
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
- Single (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 the current ESC Guidelines or ACCF/AHA/HRS Class I or Class IIa indications for CRT implant (including upgrades from single or dual chamber ICDs)
- •Must be willing and able to comply with study requirements
- •Must indicate their understanding of the study and willingness to participate by signing an appropriate informed consent form
排除标准
- •Already had a CRT device implanted
- •Myocardial Infarction, unstable angina within 40 days prior the enrollment
- •Recent cardiac revascularization (PTCA, Stent or CABG) in the 4 weeks prior to enrollment or planned for the 3 months following
- •Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) in the 3 months prior the enrollment
- •Primary valvular disease
- •Atrial Fibrillation:
- •Persistent AF at the time of enrollment
- •Permanent AF not treated with AV node ablation within 2 weeks from the CRT implant
- •History or incidence of Paroxysmal or Persistent AF within 30 days prior the enrollment
- •Unable to comply with the follow up schedule
- •Less than 18 years of age
- •Pregnant or are planning to become pregnant during the duration of the investigation
- •Classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 12 months
- •Undergone a cardiac transplantation
- •Life expectancy < 12 months
- •Currently participating in any other clinical investigation
研究组 & 干预措施
MPP OFF
MPP OFF: feature not enabled
MPP ON
MPP ON: feature is enabled
干预措施: MPP (Device)
结局指标
主要结局
Percentage of Non-responder Patients Who Converted to Responders
时间窗: Non-responder to responder conversion rate between randomization at 6 months and 12 months
The primary endpoint of this study is evaluated at 12 months after enrollment and it is defined as the percentage of non-responder patients converted to responders after 6 months of MPP feature turned ON compared to baseline, as measured by Left Ventricular End Systolic Volume (LVESV) reduction of at least 15%.
次要结局
- NYHA Class Changes(Baseline vs 12 Months)
- 6MWT Changes(Baseline vs 12 Months)
- Reduction of Left Ventricular End-systolic Volume (LVESV) in Acute Phase(Baseline vs 6 Months)
- Clinical Composite Score Evaluation(Baseline vs 12 Months)
- Reverse Left Ventricular (LV) Remodeling(Baseline vs 12 Months)
- Patient's QoL Score Changes (MLWHF)(Baseline vs 12 Months)