Heart Failure and Sudden Cardiac Death Japan Registry

NCT03185832 | Completed Results FDA Device

• 1 other identifier: C2076
• Study Type: observational
• Target: 354
• Locations: 1 country
• Sites: 34

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. 1.Selected subject cohort with criteria for SCD (without spontaneous prior ventricular sustained arrhythmia) and de novo Implantable Cardioverter-Defibrillator (ICD) device treatment.
2. 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. 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. 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.

Conditions

Heart Failure; Arrhythmias, Cardiac; Sudden Cardiac Death

Keywords

Hear failure; Sudden Cardiac Death; Arrhythmia; Implanted device; ICD; CRT

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Ventricular Arrhythmia Associated Symptoms - ICD/CRT-D Cohorts

  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.

  12 months follow up

• Number of Participant Deaths - Pacing Cohort

  All-cause mortality in subjects with a maximum of 3 risk factors (analyzed for MADIT II data).

  12 months follow up

• Number of Participant Deaths - Non-Device Cohort

  All-cause mortality in the subject cohort with 2 to 5 predefined SCD driving risk factors.

  12 months follow up

Secondary Outcomes (3)

• Number of Participant Deaths - ICD/CRT-D Cohorts

  12 months follow up

• Number of Participants With Composite HF Event - ICD/CRT-D/Pacing Cohorts

  12 months follow up

• Number of Participants With Complication - ICD/CRT-D/Pacing Cohorts

  12 months follow up

Study Arms (4)

CRT-D Cohort

Number of participants with first appropriately treated ventricular arrhythmia

Device: CRT-D

ICD Cohort

Number of participants with first appropriately treated ventricular arrhythmia

Device: ICD

Pacing (PM / CRT-P) Cohort

All cause mortality

Device: PM / CRT-P

Non-device Cohort

All-cause mortality in the subject cohort with 2 to 5 predefined SCD driving risk factors

Other: Non-device

Interventions

CRT-D DEVICE

This subject cohort is made by all patients enrolled and implanted with defibrillator with CRT capabilities

CRT-D Cohort

ICD DEVICE

This subject cohort is made by all patients enrolled and implanted with defibrillator capabilities

ICD Cohort

PM / CRT-P DEVICE

This subject cohort is made by all patients enrolled and implanted with pacemakers with or without CRT capabilities

Pacing (PM / CRT-P) Cohort

Non-device OTHER

Patient enrolled but not implanted with a Defibrillator or Pacemaker

Non-device Cohort

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The subjects enrolled in this observational registry are from the general population seen by enrolling physicians at primary care clinic.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead
• ICON Clinical Research: collaborator

Study Sites (34)

Ichinomiya Municipal Hospital

Ichinomiya, Aichi-ken, 491-8558, Japan

Location

Nagoya University Hospital

Nagoya, Aichi-ken, 466-8560, Japan

Location

Japanese Red Cross Nagoya Daini Hospital

Nagoya, Aichi-ken, 466-8650, Japan

Location

Toho University Sakura Medical Center

Sakura, Chiba, 285-8741, Japan

Location

Juntendo University Urayasu Hospital

Urayasu, Chiba, 279-0021, Japan

Location

Fukuoka Tokushukai Hospital

Kasuga, Fukuoka, 816-0864, Japan

Location

Sapporo Medical University Hospital

Sapporo, Hokkaido, 060-8543, Japan

Location

Sapporo Higashi Tokushukai Hospital

Sapporo, Hokkaido, 065-0033, Japan

Location

Kansai Rosai Hospital

Amagasaki, Hyōgo, 660-8511, Japan

Location

Hyogo Brain and Heart Center

Himeji, Hyōgo, 670-0981, Japan

Location

Hitachi General Hospital

Hitachi, Ibaraki, 317-0077, Japan

Location

University of Tsukuba Hospital

Tsukuba, Ibaraki, 305-8576, Japan

Location

St. Marianna University School of Medicine Hospital

Kawasaki, Kanagawa, 216-8511, Japan

Location

Yokohama Rosai Hospital

Yokohama, Kanagawa, 222-0036, Japan

Location

Yokohama Minami Kyousai Hospital

Yokohama, Kanagawa, 236-0037, Japan

Location

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

Yokohama, Kanagawa, 241-0811, Japan

Location

Tohoku University Hospital

Sendai, Miyagi, 980-8574, Japan

Location

National Cerebral and Cardiovascular Center Hospital

Suita, Osaka, 564-8565, Japan

Location

Osaka University Hospital

Suita, Osaka, 565-0871, Japan

Location

Jichi Medical University Hospital

Shimotsuke, Tochigi, 329-0498, Japan

Location

Tokyo Medical and Dental University Medical Hospital

Bunkyo, Tokyo, 113-8519, Japan

Location

Nippon Medical School Hospital

Bunkyō, Tokyo, 113-8603, Japan

Location

St. Luke's International Hospital

Chūō, Tokyo, 104-8560, Japan

Location

Toho University Ohashi Medicine Center

Meguro City, Tokyo, 153-8515, Japan

Location

Toho University Omori Medical Center

Ōta-ku, Tokyo, 143-8541, Japan

Location

Tokyo Metropolitan Hiroo Hospital

Shibuya City, Tokyo, 150-0013, Japan

Location

Yamaguchi University Hospital

Ube, Yamaguchi, 755-8505, Japan

Location

Kokura Memorial Hospital

Fukuoka, 802-8555, Japan

Location

Kyushu University Hospital

Fukuoka, 812-8582, Japan

Location

Okayama University Hospital

Okayama, 700-8558, Japan

Location

Sakurabashi Watanabe Hospital

Osaka, 530-0001, Japan

Location

Osaka General Medical Center

Osaka, 558-8558, Japan

Location

Jichi Medical University Saitama Medical Center

Saitama, 330-8503, Japan

Location

Japanese Red Cross Saitama Hospital

Saitama, 330-8553, Japan

Location

MeSH Terms

Conditions

Heart Failure; Arrhythmias, Cardiac; Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Arrest; Death, Sudden; Death

Results Point of Contact

• Title: Caroline Beaudoint
• Organization: Boston Scientific

Caroline.Beaudoint@bsci.com

+32479904163

Study Officials

• Kazutaka Aonuma, Professor

  University of Tsukuba Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: June 14, 2017
• Study Start: July 21, 2017
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: February 14, 2022
• Results First Posted: February 14, 2022

Record last verified: 2022-02

Locations

JP (34)