Heart Failure and Sudden Cardiac Death Japan Registry

Study Overview
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Brief Summary
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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.

Official Title
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Heart Failure Indication and Sudden Cardiac Death Prevention Trial Japan

Conditions
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Heart Failure, Arrhythmias, Cardiac, Sudden Cardiac Death

Intervention / Treatment
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* Device: CRT-D
* Device: ICD
* Device: PM / CRT-P
* Other: Non-device


Participation Criteria
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Eligibility Criteria
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General Inclusion Criteria: 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 General Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CRT-D Cohort<br>Number of participants with first appropriately treated ventricular arrhythmia | Device: CRT-D<br>* This subject cohort is made by all patients enrolled and implanted with defibrillator with CRT capabilities<br>|
| ICD Cohort<br>Number of participants with first appropriately treated ventricular arrhythmia | Device: ICD<br>* This subject cohort is made by all patients enrolled and implanted with defibrillator capabilities<br>|
| Pacing (PM / CRT-P) Cohort<br>All cause mortality | Device: PM / CRT-P<br>* This subject cohort is made by all patients enrolled and implanted with pacemakers with or without CRT capabilities<br>|
| Non-device Cohort<br>All-cause mortality in the subject cohort with 2 to 5 predefined SCD driving risk factors | Other: Non-device<br>* Patient enrolled but not implanted with a Defibrillator or Pacemaker<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Ventricular Arrhythmia Associated Symptoms - ICD/CRT-D Cohorts | 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. | 12 months follow up | 
| Number of Participant Deaths - Pacing Cohort | All-cause mortality in subjects with a maximum of 3 risk factors (analyzed for MADIT II data). | 12 months follow up | 
| Number of Participant Deaths - Non-Device Cohort | All-cause mortality in the subject cohort with 2 to 5 predefined SCD driving risk factors. | 12 months follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participant Deaths - ICD/CRT-D Cohorts | All-cause mortality for the ICD and the CRT-D cohorts. | 12 months follow up | 
| Number of Participants With Composite HF Event - ICD/CRT-D/Pacing Cohorts | Number of Participants with HF events, which require intravenous (IV) treatment and/or heart failure (HF) related hospitalization, or which led to HF death | 12 months follow up | 
| Number of Participants With Complication - ICD/CRT-D/Pacing Cohorts | Complication refers to qualified serious adverse device effects (SADEs) post success implantation, such as re-implant procedure, required invasive procedure related to the device system, pacing exit block, all-cause infection, and death due to therapy failure. | 12 months follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hear failure, Sudden Cardiac Death, Arrhythmia, Implanted device, ICD, CRT