Phase
Condition
Chest Pain
Cardiac Ischemia
Circulation Disorders
Treatment
N/AClinical Study ID
Ages > 20 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 thisstudy at an approved clinical study site and at the intervals defined by this ClinicalInvestigation Plan (CIP)
- 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:
- 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
- Device implant revision is scheduled due to unstable result of an implant <45 daysprior enrolment
- 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
- 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 coronaryintervention (PCI) within the past three calendar months prior to enrollment
- Subjects with enzyme-positive myocardial infarction within the past three calendarmonths 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 visitsassociated with this clinical study at an approved clinical study center and at theintervals 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 studyenrolment
- 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
Connect with a study center
Ichinomiya Municipal Hospital
Ichinomiya, Aichi 491-8558
JapanSite Not Available
Japanese Red Cross Nagoya Daini Hospital
Nagoya, Aichi 466-8650
JapanSite Not Available
Nagoya University Hospital
Nagoya, Aichi 466-8560
JapanSite Not Available
Toho University Sakura Medical Center
Sakura, Chiba 285-8741
JapanSite Not Available
Juntendo University Urayasu Hospital
Urayasu, Chiba 279-0021
JapanSite Not Available
University of Fukui Hospital
Yoshida, Fukui 910-1193
JapanSite Not Available
Fukuoka Tokushukai Hospital
Kasuga, Fukuoka 816-0864
JapanSite Not Available
Sapporo Higashi Tokushukai Hospital
Sapporo, Hokkaido 065-0033
JapanSite Not Available
Sapporo Medical University Hospital
Sapporo, Hokkaido 060-8543
JapanSite Not Available
Kansai Rosai Hospital
Amagasaki, Hyogo 660-8511
JapanSite Not Available
Hyogo Brain and Heart Center
Himeji, Hyogo 670-0981
JapanSite Not Available
Hitachi General Hospital
Hitachi, Ibaraki 317-0077
JapanSite Not Available
University of Tsukuba Hospital
Tsukuba, Ibaraki 305-8576
JapanSite Not Available
St. Marianna University School of Medicine Hospital
Kawasaki, Kanagawa 216-8511
JapanSite Not Available
St. Marianna University School of Medicine, Yokohama City Seibu Hospital
Yokohama, Kanagawa 241-0811
JapanSite Not Available
Yokohama Minami Kyousai Hospital
Yokohama, Kanagawa 236-0037
JapanSite Not Available
Yokohama Rosai Hospital
Yokohama, Kanagawa 222-0036
JapanSite Not Available
Tohoku University Hospital
Sendai, Miyagi 980-8574
JapanSite Not Available
National Cerebral and Cardiovascular Center Hospital
Suita, Osaka 564-8565
JapanSite Not Available
Osaka University Hospital
Suita, Osaka 565-0871
JapanSite Not Available
Jichi Medical University Hospital
Shimotsuke, Tochigi 329-0498
JapanSite Not Available
Tokyo Medical and Dental University Medical Hospital
Bunkyo, Tokyo 113-8519
JapanSite Not Available
Nippon Medical School Hospital
Bunkyō, Tokyo 113-8603
JapanSite Not Available
Nippon Medical School
Bunkyō-Ku, Tokyo 113-8603
JapanSite Not Available
St. Luke's International Hospital
Chuo, Tokyo 104-8560
JapanSite Not Available
St. Luke's International Hospital
Chuo Ku, Tokyo 104-8560
JapanSite Not Available
Toho University Ohashi Medicine Center
Meguro, Tokyo 153-8515
JapanSite Not Available
Tokyo Metropolitan Hiroo Hospital
Shibuya, Tokyo 150-0013
JapanSite Not Available
Toho University Omori Medical Center
Ōta, Tokyo 143-8541
JapanSite Not Available
Yamaguchi University Hospital
Ube, Yamaguchi 755-8505
JapanSite Not Available
Kokura Memorial Hospital
Fukuoka, 802-8555
JapanSite Not Available
Kyushu University Hospital
Fukuoka, 812-8582
JapanSite Not Available
Okayama University Hospital
Okayama, 700-8558
JapanSite Not Available
Osaka General Medical Center
Osaka, 558-8558
JapanSite Not Available
Sakurabashi Watanabe Hospital
Osaka, 530-0001
JapanSite Not Available
Japanese Red Cross Saitama Hospital
Saitama, 330-8553
JapanSite Not Available
Jichi Medical University Saitama Medical Center
Saitama, 330-8503
JapanSite Not Available
Sakurabashi Watanabe Hospital
Ōsaka, 530-0001
JapanSite Not Available

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