Last updated on February 2019

Heart Failure and Sudden Cardiac Death Japan Registry


Brief description of study

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 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-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 PM/CRT-P patient cohort.

The All-cause mortality will be assessed in the non-implanted subject cohort.

Clinical Study Identifier: NCT03185832

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Kazutaka Aonuma

University of Tsukuba Hospital
Tsukuba, Japan
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Kenji Ando

Kokura Memorial Hospital
Fukuoka, Japan
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Toru Asai

Ichinomiya Municipal Hospital
Ichinomiya, Japan
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Yukihiko Yoshida

Japanese Red Cross Nagoya Daini Hospital
Nagoya, Japan
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Yuji Nakazato

Juntendo University Urayasu Hospital
Urayasu, Japan
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Hideki Shimomura

Fukuoka Tokushukai Medical Center
Kasuga, Japan
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Daigo Nagahara

Sapporo Medical University Hospital
Sapporo, Japan
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Torsten Kayser, Dr.

Kansai Rosai Hospital
Amagasaki, Japan
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Akira Shimane

Hyogo Brain and Heart Center
Himeji, Japan
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Yutaka Eki

Hitachi General Hospital
Hitachi, Japan
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Shinya Kowase

Yokohama Rosai Hospital
Yokohama, Japan
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Makoto Nakano

Tohoku University Hospital
Sendai, Japan
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Yasushi Sakata

Osaka University Hospital
Suita, Japan
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Kengo Kusano

National Cerebral and Cardiovascular Center Hospital
Suita, Japan
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Torsten Kayser, Dr.

Nagoya University Hospital
Nagoya, Japan
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Torsten Kayser, Dr.

Toho University Sakura Medical
Sakura, Japan
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Torsten Kayser, Dr.

University of Fukui Hospital
Yoshida, Japan
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Tomoyuki Tani

Sapporo Higashi Tokushukai Hospital
Sapporo, Japan
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Torsten Kayser, Dr.

St. Marianna University School of Medicine Hospital
Kawasaki, Japan
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Torsten Kayser, Dr.

Yokohama Minami Kyosai Hospital
Yokohama, Japan
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Recruitment Status: Open


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