MIRACLE-ICD outcome measured in Japanese indication

MIRACLE-ICD outcome measured in Japanese indication - MOMIJI study (MIRACLE-ICD outcome measured in Japanese indication)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000000566

Enrollment

252

Registered

2007-02-01

Start date

2007-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congestive Heart Failure, Ventricular Tachyarrhythmia.

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age >= 20 years. 2. Heart failure patients whose symptoms have not improved despite optimal pharmacological therapy who meet all the criteria listed in A) below as well as the criteria in either B) or C). (with the exception of patients with disease of transient or reversible cause) A) Indicated heart failure patients. a. NYHA class III or IV b. LVEF <= 35% c. QRS duration >= 130 ms B) Patient with one of the following risks for sudden cardiac death. a. History of resuscitation from cardiac arrest following fatal arrhythmia (clear loss of consciousness). b. VT or VF that disrupts hemodynamics c. Confirmed NSVT and VT or VF induced by electrophysiological testing. C) Patients who meet the Japanese criteria for implantation of an ICD. 3. Patients who signed the informed consent and Permission for Access to and Use of Health Information. 4. Patients who are willing to visit the hospital accordance with follow up schedule.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

Japan

Contacts

Public ContactTomoyuki Tejima

Medtronic Japan, Co., Ltd. CRDM Clinical Research

tomoyuki.tejima@medtronic.com03-6430-7023

Outcome results