Heart Failure and Sudden Cardiac Death Japan Registry (HINODE)

Boston Scientific

Status

Completed

Conditions

Arrhythmias, Cardiac

Heart Failure

Sudden Cardiac Death

Treatments

Device: ICD

Other: Non-device

Device: PM / CRT-P

Device: CRT-D

Study type

Observational

Funder types

Industry

Identifiers

NCT03185832

C2076

Details and patient eligibility

About

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:

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

Enrollment

354 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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 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.