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UMIN ID: UMIN000000566

Registered date:01/02/2007

MIRACLE-ICD outcome measured in Japanese indication

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedCongestive Heart Failure, Ventricular Tachyarrhythmia.
Date of first enrollment2007/04/01
Target sample size252
Countries of recruitmentJapan
Study typeObservational


Primary OutcomeTo evaluate the clinical effectiveness of CRT-D device therapy in Japanese patients with Japanese criteria by comparing with pre-specified MIRACLE-ICD results
Secondary Outcome1. Characterize the clinical utility of CRT-D therapy in Japanese Patients. 2. Describe the effectiveness of Anti-Tachycardia Pacing (ATP) for terminating Ventricular Tachycardias (VT). 3. Describe the medico-economic characteristics of CRT-D device therapy.

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1. Estimated survival < 6 months. 2. Bradycardia requiring pacemaker. 3. Unstable angina, myocardial infarction, coronary angioplasty, cerebral vascular accident, or transient ischemic attack within previous 3 months. 4. > 2 infusion of inotropic drug per week. 5. Systolic blood pressure < 80 mmHg or >170 mmHg. 6. Resting heart rate > 140/min. 7. Serum creatinine > 3 mg/dL (> 265 umol/L). 8. Hepatic enzymes >3-fold upper normal values. 9. Severe lung disease. 10. Chronic AF. 11. Heart transplant recipient. 12. Severe valvular heart disease (the decision on severity is made by a medical doctor). 13. Existing CRT or CRT-D device.

Related Information


public contact
Name Tomoyuki Tejima
Address Tokyo Japan
Telephone 03-6430-7023
Affiliation Medtronic Japan, Co., Ltd. CRDM Clinical Research
scientific contact
Name Soichi Tsunoda
Address Tokyo Japan
Telephone 03-6430-7023
Affiliation Medtronic Japan, Co., Ltd. Cardiac Rhythm Disease Management, Clinical Research