Last updated on April 2019

Heart Failure and Sudden Cardiac Death Japan Registry


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Sudden Cardiac Death | Arrhythmia | Heart failure
  • Age: Between 20 - 100 Years
  • Gender: Male or Female

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 CIP
  4. Measured Ejection fraction value obtained by echocardiography or equivalent method as
    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, MI or revascularization, otherwise within the last 3 months prior to enrollment

And 12 lead 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 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, 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 PG device.

Additional eligibility criteria apply to each cohort

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Volunteer Sign-up

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.