Heart Failure and Sudden Cardiac Death Japan Registry

Exclusion Criteria

• •1. 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
• •2. Device implant revision is scheduled due to unstable result of an implant \<45 days prior enrolment
• •3. 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
• •4. Subjects with chronic renal disease with chronic BUN ≥50mg/dL or creatinine ≥2.5 mg/dL
• •5. Subjects with coronary artery bypass graft (CABG) surgery or percutaneous coronary intervention (PCI) within the past three calendar months prior to enrollment
• •6. Subjects with enzyme-positive myocardial infarction within the past three calendar months prior to enrollment
• •7. Subjects who are expected to survive for \<1 year with good functional status
• •8. Subject's physician does not allow participation
• •9. 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
• •10. Unwilling to sign the consent for participation
• •11. Women of childbearing potential who are or might be pregnant at the time of study enrolment
• •12. 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