Simultaneous Or Sequential multiPoint Pacing in Cardiac Resynchronization Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Acute QRS duration changes during multipoint CRT
研究概览
简要总结
The purpose of this study is to compare electrical acute changes between simultaneous and sequential LV pacing and to assess the paced QRSd over a range of inter- and intra-ventricular programmable delays setting during MPP pacing.
详细描述
The study will be a prospective, single-arm, non-randomized, non-blinded, acute study conducted at CRT device implant and prior to subject discharge. Subjects scheduled to be implanted with a Quadripolar Pacing System who provide informed consent will undergo "Enrollment" and participate in "SCOPE-CRT" study. Enrollment and device implant can occur in the same day. Including Enrollment, each subject's participation is expected to be 1-2 days. The total duration of the study is expected to be 12 months, including Enrollment. Enrollment will include the Informed Consent process, physical examination, and collection of demographics, cardiovascular history, medical history, and medications.
During CRT implant, surface ECG and PV loop recordings will be taken over the different programmable MPP settings. Following data collection, CRT device programming will be left to the discretion of the physician.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with approved indication for CRT by European Society of Cardiology/European Heart Rhythm Association guidelines (ESC/EHRA)
- •QRS duration > 130 ms
- •Ability to provide informed consent for study participation
- •At least 18 years of age
排除标准
- •Myocardial infarction within 40 days before enrolment
- •NYHA Class IV
- •Tachyarrhythmia caused by temporary or reversible irritation, e.g. poisoning, electrolyte imbalance, hypoxia, sepsis or acute myocardial infarction
- •Such frequent VT or VF that the therapies would cause an unacceptably rapid depletion of the device batteries
- •VT with few or without clinically relevant symptoms
- •VT or VF treatable by surgery
- •Concomitant diseases that would substantially limit a positive prognosis
- •Accelerated intrinsic rhythm
- •Women who are pregnant
结局指标
主要结局
Acute QRS duration changes during multipoint CRT
时间窗: 1 day during CRT
Quantify acute changes in surface ECG QRS duration between simultaneous and sequential LV pacing during MPP pacing.
次要结局
- Acute changes in hemodynamics between simultaneous and sequential LV pacing during multipoint CRT(1 day during CRT)
- Acute ECG QRS duration changes during multipoint CRT(1 day during CRT)
研究者
Carlo Pappone
Chief of Arrhythmology Department IRCCS SAn Donato Policlinico, University of Milan, Italy
IRCCS Policlinico S. Donato