Quartet Lead and Resynchronization Therapy Options - Assessing the Response Rate at 6 Months in CRT Patients Implanted With a Quartet Left Ventricular(LV) Quadripolar Lead and the MultiPoint Pacing (MPP) Feature Activated
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Number of CRT Responders
研究概览
简要总结
The purpose of the study is to assess prospectively at 6 months the percentage of responder patients implanted with a Cardiac Resynchronization Therapy (CRT-D) device and a Quartet Left Ventricular (LV) quadripolar lead and with the MultiPoint Pacing (MPP) feature activated.
详细描述
The primary endpoint of the study is to measure prospectively at 6 months the percentage of responder* patients implanted with a Quartet LV quadripolar lead and with the MultiPoint Pacing feature activated compared with No Pacing at baseline.
*A positive CRT response is defined as an improvement of more than 15 % in Left Ventricular End Systolic Volume (LVESV) at 6 months post-implant, measured by Echocardiography.
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 that will be implanted with a Cardiac Resynchronization Therapy (CRT-D) with the MultiPoint Pacing (MPP) feature under the current Guidelines indications for CRT-D implant (including upgrades from single or dual chamber Defibrillator or Pacemaker).
- •Patient that will be implanted with a Quartet Left Ventricular (LV) quadripolar lead.
- •In sinus rhythm at baseline visit.
- •Patients with Left Bundle Branch Block (LBBB)
- •Must be willing and able to comply with study requirements.
- •Older than 18 years
- •Must indicate their understanding of the study and willingness to participate by signing an appropriate informed consent form.
排除标准
- •Already has a CRT device implanted.
- •Myocardial Infarction or unstable angina within 40 days prior the enrollment.
- •New York Heart Association (NYHA) Class IV
- •Recent cardiac revascularization in the 4 weeks prior to enrollment.
- •Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) in the 3 months prior the enrollment.
- •Classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 12 months.
- •Primary valvular disease requiring surgical intervention.
- •Atrial Fibrillation (AF):
- •Persistent AF at the time of enrollment or 30 days prior the enrollment
- •Permanent AF not treated with Atrio-Ventricular node ablation within 2 weeks after the CRT-D implant
- •History or incidence of Paroxysmal or Persistent AF within 30 days prior the enrollment
- •Patient for whom suitable Transthoracic echocardiographic images for determining the cardiac output (CO) and LV volumes cannot be obtained.
- •Undergone a cardiac transplantation or being waiting for it
- •Life expectancy < 6 months
- •Pregnancy or planning to become pregnant
- •Unable to comply with the follow up schedule
- •Currently participating in any other clinical investigation.-
研究组 & 干预措施
MPP ON
To activate the Multipoint Pacing (MPP) feature to ON in all patients
干预措施: MPP ON (Device)
结局指标
主要结局
Number of CRT Responders
时间窗: 6 months
The number of CRT responders was evaluated at 6 months post-implant. A CRT responder patient was a patient with an improvement of \>15 % in LVESV, as measured by echocardiography.
次要结局
- Changes in LV Echocardiographic Parameters(Baseline and 6 months)
- Change in NYHA Classification(6 months)
- Number of CRT Super-responders(6 months)
- Rates of Hospitalization and Mortality(6 months)