Heart Failure Indication and Sudden Cardiac Death Prevention Trial Japan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 354
- 试验地点
- 34
- 主要终点
- Number of Participants With Ventricular Arrhythmia Associated Symptoms - ICD/CRT-D Cohorts
研究概览
简要总结
The purpose of this observational registry is to collect clinical events and outcome data in 4 different study populations (cohorts), with a majority of Japanese subjects, that are at risk of sudden cardiac death (SCD) and heart failure (HF) events. These event rates will be compared with available published data mainly from Europe and the United States.
Selected Subject Cohorts:
- Selected subject cohort with criteria for SCD (without spontaneous prior ventricular sustained arrhythmia) and de novo Implantable Cardioverter-Defibrillator (ICD) device treatment.
- Selected subject cohort with criteria for SCD and widely accepted standard cardiac resynchronization therapy (CRT) indication who received a de novo CRT-Defibrillator (CRT-D) device treatment.
- Selected subject cohort who are clinically expected to require >40% right ventricular pacing with a left ventricular ejection fraction (LVEF) ≤50%, any determined New York Heart Association (NYHA) Class, and receiving pacemaker (PM) or CRT-Pacemaker (CRT-P) therapy despite previous device history (de novo, box changes, system revisions or upgrades).
- Selected subject cohort with criteria for SCD fulfilling European Society of Cardiology (ESC) ICD or CRT-D therapy guidelines (2016) with an LVEF ≤35%, having 2 to 5 predefined SCD risk factors but do not have or had have a cardiac implanted defibrillator, CRT-D, PM, or CRT-P.
The primary endpoint will report on the Composite rate of first appropriately treated ventricular arrhythmia (by anti-tachycardia pacing [ATP] or shock) or life-threatening symptoms associated to ventricular arrhythmia (defined as hemodynamic instability which requires treatment), whichever comes first under MADIT RIT Arm B or C programming conditions in a study population with a majority of Japanese subjects. This primary end point is assessed in the ICD/CRT-D implanted patient cohort.
The all-cause mortality in subjects with a maximum of 3 risk factors (analyzed for MADIT II data) will be assessed in the Pacing (PM/CRT-P) patient cohort.
The all-cause mortality will be assessed in the non-implanted subject cohort.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is aged 20 or above
- •Subject is willing and capable of providing informed consent
- •Subject is willing and capable of participating in all visits associated with this study at an approved clinical study site and at the intervals defined by this Clinical Investigation Plan (CIP)
- •Measured Ejection fraction value obtained by echocardiography or equivalent method as Standard of Care (SOC):
- •Device cohorts: within the last 3 months prior to enrolment
- •Non-device cohort: latest available within the last 12 months prior to enrollment in case there was no documented HF decompensation, myocardial infarction (MI) or revascularization, otherwise within the last 3 months prior to enrollment
- •And 12 lead electrocardiogram (ECG) recording available as SOC:
- •Device cohorts: pre-implant ECG maximum 45 days before implant; post-implant ECG
- •Non-device cohort: latest available maximum 12 months prior to enrollment and subject agrees in the data being used for this study
排除标准
- •Subject is enrolled in any other concurrent study without prior written approval from Boston Scientific (BSC), with the exception of local mandatory governmental registries and observational studies/registries that are not in conflict and do not affect the following:
- •Schedule of procedures for the HINODE Study (i.e. should not cause additional or missed visits)
- •HINODE Study outcome
- •Conduct of the HINODE Study per Good Clinical Practice /International Standard Organization 14155:2011/local regulations as applicable
- •Device implant revision is scheduled due to unstable result of an implant <45 days prior enrolment
- •Subjects with more than 5 of the following risk factors: LVEF <35%, NYHA Class III or IV, left bundle branch block (LBBB) with QRS > 130 ms or QRS ≥150 ms, renal dysfunction (chronically BUN >26 mg/dL / ≥9.28 mmol/L), diabetes type I and II, chronic atrial fibrillation (permanent or persistent according to ESC Guideline 2016), prior MI, age >70 years, smoking today or during last 5 years
- •Subjects with chronic renal disease with chronic BUN ≥50mg/dL or creatinine ≥2.5 mg/dL
- •Subjects with coronary artery bypass graft (CABG) surgery or percutaneous coronary intervention (PCI) within the past three calendar months prior to enrollment
- •Subjects with enzyme-positive myocardial infarction within the past three calendar months prior to enrollment
- •Subjects who are expected to survive for <1 year with good functional status
- •Subject's physician does not allow participation
- •Subject is not willing and capable of participating in all testing or visits associated with this clinical study at an approved clinical study center and at the intervals defined by this CIP
- •Unwilling to sign the consent for participation
- •Women of childbearing potential who are or might be pregnant at the time of study enrolment
- •ICD and CRT-D cohorts: implanted with a non-BSC device system. PM/CRT-P cohorts: implanted with a non-BSC pulse generator device.
- •Additional eligibility criteria apply to each cohort
结局指标
主要结局
Number of Participants With Ventricular Arrhythmia Associated Symptoms - ICD/CRT-D Cohorts
时间窗: 12 months follow up
Number of Participants with first appropriately treated ventricular arrhythmia (by anti tachycardia pacing \[ATP\] or shock) or life-threatening symptoms associated to ventricular arrhythmia (defined as hemodynamic instability which requires treatment), whichever comes first under MADIT Arm B or C programming conditions in a study population with a majority of Japanese subjects.
Number of Participant Deaths - Pacing Cohort
时间窗: 12 months follow up
All-cause mortality in subjects with a maximum of 3 risk factors (analyzed for MADIT II data).
Number of Participant Deaths - Non-Device Cohort
时间窗: 12 months follow up
All-cause mortality in the subject cohort with 2 to 5 predefined SCD driving risk factors.
次要结局
- Number of Participants With Complication - ICD/CRT-D/Pacing Cohorts(12 months follow up)
- Number of Participant Deaths - ICD/CRT-D Cohorts(12 months follow up)
- Number of Participants With Composite HF Event - ICD/CRT-D/Pacing Cohorts(12 months follow up)