Heart Failure and Sudden Cardiac Death Japan Registry

Completed

Conditions: Heart Failure
Arrhythmias, Cardiac
Sudden Cardiac Death

Interventions: Device: CRT-D
Device: ICD
Other: Non-device
Device: PM / CRT-P

Registration Number: NCT03185832

Lead Sponsor: Boston Scientific Corporation

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 354

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 this study at an approved clinical study site and at the intervals defined by this Clinical Investigation Plan (CIP)
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

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
Device implant revision is scheduled due to unstable result of an implant <45 days prior enrolment
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
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 coronary intervention (PCI) within the past three calendar months prior to enrollment
Subjects with enzyme-positive myocardial infarction within the past three calendar months 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 visits associated with this clinical study at an approved clinical study center and at the intervals 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 study enrolment
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

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CRT-D Cohort	CRT-D	Number of participants with first appropriately treated ventricular arrhythmia
ICD Cohort	ICD	Number of participants with first appropriately treated ventricular arrhythmia
Non-device Cohort	Non-device	All-cause mortality in the subject cohort with 2 to 5 predefined SCD driving risk factors
Pacing (PM / CRT-P) Cohort	PM / CRT-P	All cause mortality

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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

Trial Locations

Locations (34): Toho University Ohashi Medicine Center
🇯🇵
Meguro, Tokyo, Japan
Sapporo Medical University Hospital
🇯🇵
Sapporo, Hokkaido, Japan
University of Tsukuba Hospital
🇯🇵
Tsukuba, Ibaraki, Japan
St. Luke's International Hospital
🇯🇵
Chuo, Tokyo, Japan
Kansai Rosai Hospital
🇯🇵
Amagasaki, Hyogo, Japan
National Cerebral and Cardiovascular Center Hospital
🇯🇵
Suita, Osaka, Japan
Nagoya University Hospital
🇯🇵
Nagoya, Aichi, Japan
St. Marianna University School of Medicine, Yokohama City Seibu Hospital
🇯🇵
Yokohama, Kanagawa, Japan
Osaka University Hospital
🇯🇵
Suita, Osaka, Japan
Nippon Medical School Hospital
🇯🇵
Bunkyō, Tokyo, Japan
Toho University Omori Medical Center
🇯🇵
Ōta, Tokyo, Japan
Fukuoka Tokushukai Hospital
🇯🇵
Kasuga, Fukuoka, Japan
Japanese Red Cross Saitama Hospital
🇯🇵
Saitama, Japan
Tokyo Medical and Dental University Medical Hospital
🇯🇵
Bunkyo, Tokyo, Japan
Tokyo Metropolitan Hiroo Hospital
🇯🇵
Shibuya, Tokyo, Japan
Osaka General Medical Center
🇯🇵
Osaka, Japan
Jichi Medical University Hospital
🇯🇵
Shimotsuke, Tochigi, Japan
Yamaguchi University Hospital
🇯🇵
Ube, Yamaguchi, Japan
Kyushu University Hospital
🇯🇵
Fukuoka, Japan
Ichinomiya Municipal Hospital
🇯🇵
Ichinomiya, Aichi, Japan
Toho University Sakura Medical Center
🇯🇵
Sakura, Chiba, Japan
Japanese Red Cross Nagoya Daini Hospital
🇯🇵
Nagoya, Aichi, Japan
Juntendo University Urayasu Hospital
🇯🇵
Urayasu, Chiba, Japan
Yokohama Minami Kyousai Hospital
🇯🇵
Yokohama, Kanagawa, Japan
Hitachi General Hospital
🇯🇵
Hitachi, Ibaraki, Japan
St. Marianna University School of Medicine Hospital
🇯🇵
Kawasaki, Kanagawa, Japan
Yokohama Rosai Hospital
🇯🇵
Yokohama, Kanagawa, Japan
Tohoku University Hospital
🇯🇵
Sendai, Miyagi, Japan
Sapporo Higashi Tokushukai Hospital
🇯🇵
Sapporo, Hokkaido, Japan
Hyogo Brain and Heart Center
🇯🇵
Himeji, Hyogo, Japan
Kokura Memorial Hospital
🇯🇵
Fukuoka, Japan
Okayama University Hospital
🇯🇵
Okayama, Japan
Sakurabashi Watanabe Hospital
🇯🇵
Osaka, Japan
Jichi Medical University Saitama Medical Center
🇯🇵
Saitama, Japan