Heart Failure and Sudden Cardiac Death Japan Registry

Last updated: February 11, 2022
Sponsor: Boston Scientific Corporation
Overall Status: Completed

Phase

N/A

Condition

Chest Pain

Cardiac Ischemia

Circulation Disorders

Treatment

N/A

Clinical Study ID

NCT03185832
C2076
  • Ages > 20
  • All Genders

Study Summary

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:

  1. Selected subject cohort with criteria for SCD (without spontaneous prior ventricular sustained arrhythmia) and de novo Implantable Cardioverter-Defibrillator (ICD) device treatment.

  2. 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.

  3. 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).

  4. 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.

Eligibility Criteria

Inclusion

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 thisstudy at an approved clinical study site and at the intervals defined by this ClinicalInvestigation Plan (CIP)
  4. Measured Ejection fraction value obtained by echocardiography or equivalent method asStandard 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 enrollmentin case there was no documented HF decompensation, myocardial infarction (MI) orrevascularization, 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 subjectagrees in the data being used for this study

Exclusion

General Exclusion Criteria:

  1. Subject is enrolled in any other concurrent study without prior written approval fromBoston Scientific (BSC), with the exception of local mandatory governmental registriesand observational studies/registries that are not in conflict and do not affect thefollowing:
  • Schedule of procedures for the HINODE Study (i.e. should not cause additional ormissed visits)
  • HINODE Study outcome
  • Conduct of the HINODE Study per Good Clinical Practice /International StandardOrganization 14155:2011/local regulations as applicable
  1. Device implant revision is scheduled due to unstable result of an implant <45 daysprior enrolment
  2. Subjects with more than 5 of the following risk factors: LVEF <35%, NYHA Class III orIV, left bundle branch block (LBBB) with QRS > 130 ms or QRS ≥150 ms, renaldysfunction (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
  3. Subjects with chronic renal disease with chronic BUN ≥50mg/dL or creatinine ≥2.5 mg/dL
  4. Subjects with coronary artery bypass graft (CABG) surgery or percutaneous coronaryintervention (PCI) within the past three calendar months prior to enrollment
  5. Subjects with enzyme-positive myocardial infarction within the past three calendarmonths prior to enrollment
  6. Subjects who are expected to survive for <1 year with good functional status
  7. Subject's physician does not allow participation
  8. Subject is not willing and capable of participating in all testing or visitsassociated with this clinical study at an approved clinical study center and at theintervals defined by this CIP
  9. Unwilling to sign the consent for participation
  10. Women of childbearing potential who are or might be pregnant at the time of studyenrolment
  11. 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

Study Design

Total Participants: 354
Study Start date:
July 21, 2017
Estimated Completion Date:
December 01, 2020

Connect with a study center

  • Ichinomiya Municipal Hospital

    Ichinomiya, Aichi 491-8558
    Japan

    Site Not Available

  • Japanese Red Cross Nagoya Daini Hospital

    Nagoya, Aichi 466-8650
    Japan

    Site Not Available

  • Nagoya University Hospital

    Nagoya, Aichi 466-8560
    Japan

    Site Not Available

  • Toho University Sakura Medical Center

    Sakura, Chiba 285-8741
    Japan

    Site Not Available

  • Juntendo University Urayasu Hospital

    Urayasu, Chiba 279-0021
    Japan

    Site Not Available

  • University of Fukui Hospital

    Yoshida, Fukui 910-1193
    Japan

    Site Not Available

  • Fukuoka Tokushukai Hospital

    Kasuga, Fukuoka 816-0864
    Japan

    Site Not Available

  • Sapporo Higashi Tokushukai Hospital

    Sapporo, Hokkaido 065-0033
    Japan

    Site Not Available

  • Sapporo Medical University Hospital

    Sapporo, Hokkaido 060-8543
    Japan

    Site Not Available

  • Kansai Rosai Hospital

    Amagasaki, Hyogo 660-8511
    Japan

    Site Not Available

  • Hyogo Brain and Heart Center

    Himeji, Hyogo 670-0981
    Japan

    Site Not Available

  • Hitachi General Hospital

    Hitachi, Ibaraki 317-0077
    Japan

    Site Not Available

  • University of Tsukuba Hospital

    Tsukuba, Ibaraki 305-8576
    Japan

    Site Not Available

  • St. Marianna University School of Medicine Hospital

    Kawasaki, Kanagawa 216-8511
    Japan

    Site Not Available

  • St. Marianna University School of Medicine, Yokohama City Seibu Hospital

    Yokohama, Kanagawa 241-0811
    Japan

    Site Not Available

  • Yokohama Minami Kyousai Hospital

    Yokohama, Kanagawa 236-0037
    Japan

    Site Not Available

  • Yokohama Rosai Hospital

    Yokohama, Kanagawa 222-0036
    Japan

    Site Not Available

  • Tohoku University Hospital

    Sendai, Miyagi 980-8574
    Japan

    Site Not Available

  • National Cerebral and Cardiovascular Center Hospital

    Suita, Osaka 564-8565
    Japan

    Site Not Available

  • Osaka University Hospital

    Suita, Osaka 565-0871
    Japan

    Site Not Available

  • Jichi Medical University Hospital

    Shimotsuke, Tochigi 329-0498
    Japan

    Site Not Available

  • Tokyo Medical and Dental University Medical Hospital

    Bunkyo, Tokyo 113-8519
    Japan

    Site Not Available

  • Nippon Medical School Hospital

    Bunkyō, Tokyo 113-8603
    Japan

    Site Not Available

  • Nippon Medical School

    Bunkyō-Ku, Tokyo 113-8603
    Japan

    Site Not Available

  • St. Luke's International Hospital

    Chuo, Tokyo 104-8560
    Japan

    Site Not Available

  • St. Luke's International Hospital

    Chuo Ku, Tokyo 104-8560
    Japan

    Site Not Available

  • Toho University Ohashi Medicine Center

    Meguro, Tokyo 153-8515
    Japan

    Site Not Available

  • Tokyo Metropolitan Hiroo Hospital

    Shibuya, Tokyo 150-0013
    Japan

    Site Not Available

  • Toho University Omori Medical Center

    Ōta, Tokyo 143-8541
    Japan

    Site Not Available

  • Yamaguchi University Hospital

    Ube, Yamaguchi 755-8505
    Japan

    Site Not Available

  • Kokura Memorial Hospital

    Fukuoka, 802-8555
    Japan

    Site Not Available

  • Kyushu University Hospital

    Fukuoka, 812-8582
    Japan

    Site Not Available

  • Okayama University Hospital

    Okayama, 700-8558
    Japan

    Site Not Available

  • Osaka General Medical Center

    Osaka, 558-8558
    Japan

    Site Not Available

  • Sakurabashi Watanabe Hospital

    Osaka, 530-0001
    Japan

    Site Not Available

  • Japanese Red Cross Saitama Hospital

    Saitama, 330-8553
    Japan

    Site Not Available

  • Jichi Medical University Saitama Medical Center

    Saitama, 330-8503
    Japan

    Site Not Available

  • Sakurabashi Watanabe Hospital

    Ōsaka, 530-0001
    Japan

    Site Not Available

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