Heart Failure Indication and Sudden Cardiac Death Prevention Trial Japan

Status: Completed
Location: See all (34) locations...
Intervention Type: Device, Other
Study Type: Observational
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: 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: No
View:

• 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

Locations
Other Locations
Japan
Kansai Rosai Hospital
Amagasaki
Tokyo Medical and Dental University Medical Hospital
Bunkyo
Nippon Medical School Hospital
Bunkyō
St. Luke's International Hospital
Chuo
Kokura Memorial Hospital
Fukuoka
Kyushu University Hospital
Fukuoka
Hyogo Brain and Heart Center
Himeji
Hitachi General Hospital
Hitachi
Ichinomiya Municipal Hospital
Ichinomiya
Fukuoka Tokushukai Hospital
Kasuga
St. Marianna University School of Medicine Hospital
Kawasaki
Toho University Ohashi Medicine Center
Meguro
Japanese Red Cross Nagoya Daini Hospital
Nagoya
Nagoya University Hospital
Nagoya
Okayama University Hospital
Okayama
Osaka General Medical Center
Osaka
Sakurabashi Watanabe Hospital
Osaka
Toho University Omori Medical Center
Ōta
Japanese Red Cross Saitama Hospital
Saitama
Jichi Medical University Saitama Medical Center
Saitama
Toho University Sakura Medical Center
Sakura
Sapporo Higashi Tokushukai Hospital
Sapporo
Sapporo Medical University Hospital
Sapporo
Tohoku University Hospital
Sendai
Tokyo Metropolitan Hiroo Hospital
Shibuya
Jichi Medical University Hospital
Shimotsuke
National Cerebral and Cardiovascular Center Hospital
Suita
Osaka University Hospital
Suita
University of Tsukuba Hospital
Tsukuba
Yamaguchi University Hospital
Ube
Juntendo University Urayasu Hospital
Urayasu
St. Marianna University School of Medicine, Yokohama City Seibu Hospital
Yokohama
Yokohama Minami Kyousai Hospital
Yokohama
Yokohama Rosai Hospital
Yokohama
Time Frame
Start Date: July 21, 2017
Completion Date: December 1, 2020
Participants
Target number of participants: 354
Treatments
CRT-D Cohort
Number of participants with first appropriately treated ventricular arrhythmia
ICD Cohort
Number of participants with first appropriately treated ventricular arrhythmia
Pacing (PM / CRT-P) Cohort
All cause mortality
Non-device Cohort
All-cause mortality in the subject cohort with 2 to 5 predefined SCD driving risk factors
Related Therapeutic Areas
Sponsors
Collaborators: ICON Clinical Research
Leads: Boston Scientific Corporation

This content was sourced from clinicaltrials.gov

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