Heart Failure and Sudden Cardiac Death Japan Registry

• CRT-D (Device): This subject cohort is made by all patients enrolled and implanted with defibrillator with CRT capabilities
• ICD (Device): This subject cohort is made by all patients enrolled and implanted with defibrillator capabilities
• PM / CRT-P (Device): This subject cohort is made by all patients enrolled and implanted with pacemakers with or without CRT capabilities
• Non-device (Other): Patient enrolled but not implanted with a Defibrillator or Pacemaker

Primary outcomes

• Number of Participants With Ventricular Arrhythmia Associated Symptoms - ICD/CRT-D Cohorts [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 [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 [12 months follow up]: All-cause mortality in the subject cohort with 2 to 5 predefined SCD driving risk factors.

Secondary outcomes

• Number of Participant Deaths - ICD/CRT-D Cohorts [12 months follow up]: All-cause mortality for the ICD and the CRT-D cohorts.
• Number of Participants With Composite HF Event - ICD/CRT-D/Pacing Cohorts [12 months follow up]: Number of Participants with HF events, which require intravenous (IV) treatment and/or heart failure (HF) related hospitalization, or which led to HF death
• Number of Participants With Complication - ICD/CRT-D/Pacing Cohorts [12 months follow up]: 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.

Sex: All, ages: 20 Years to any

General Inclusion Criteria:

1. Subject is aged 20 or above
2. Subject is willing and capable of providing informed consent
3. 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)
4. 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:

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

Participant flow

Outcome results

• Number of Participants With Ventricular Arrhythmia Associated Symptoms - ICD/CRT-D Cohorts (Primary), Count of participants, Participants: CRT-D Cohort 3; ICD Cohort 8
• Number of Participant Deaths - Pacing Cohort (Primary), Count of participants, Participants: Pacing Cohort 3
• Number of Participant Deaths - Non-Device Cohort (Primary), Count of participants, Participants: Non-device Cohort 5
• Number of Participant Deaths - ICD/CRT-D Cohorts (Secondary), Count of participants, Participants: CRT-D Cohort 5; ICD Cohort 3
• Number of Participants With Composite HF Event - ICD/CRT-D/Pacing Cohorts (Secondary), Count of participants, Participants: CRT-D Cohort 16; ICD Cohort 27; Pacing Cohort 9
• Number of Participants With Complication - ICD/CRT-D/Pacing Cohorts (Secondary), Count of participants, Participants: CRT-D Cohort 3; ICD Cohort 4; Pacing Cohort 2

Adverse events

Time frame: Adverse events are collected through study completion, an average of 20 months

Serious adverse events by term

2 more terms not shown.

Other adverse events by term

• Study Protocol and Statistical Analysis Plan (PDF, 2018-03-29)

• Kazutaka Aonuma, Professor, Principal investigator, University of Tsukuba Hospital