MIRACLE-ICD outcome measured in Japanese indication

UMIN ID: UMIN000000566

Registered date:01/02/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Congestive Heart Failure, Ventricular Tachyarrhythmia.
• Date of first enrollment: 2007/04/01
• Target sample size: 252
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: To evaluate the clinical effectiveness of CRT-D device therapy in Japanese patients with Japanese criteria by comparing with pre-specified MIRACLE-ICD results
• Secondary Outcome: 1. 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 minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1. 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

• Primary Sponsor: Medtronic Japan, Co., Ltd.
• Source(s) of Monetary Support: Medtronic Japan, Co., Ltd.