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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000566
Receipt No. R000000678
Scientific Title MIRACLE-ICD outcome measured in Japanese indication
Date of disclosure of the study information 2007/02/01
Last modified on 2010/10/22

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Basic information
Public title MIRACLE-ICD outcome measured in Japanese indication
Acronym MOMIJI study
(MIRACLE-ICD outcome measured in Japanese indication)
Scientific Title MIRACLE-ICD outcome measured in Japanese indication
Scientific Title:Acronym MOMIJI study
(MIRACLE-ICD outcome measured in Japanese indication)
Region
Japan

Condition
Condition Congestive Heart Failure, Ventricular Tachyarrhythmia.
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of the MOMIJI study is to characterize the therapy outcome in Japanese participants implanted with CRT-D. A CRT-D is a device that possesses the function of Cardiac Resynchronization Therapy (CRT) and Implantable Cardioverter Defibrillator (ICD). The focus will be on CRT-D therapy outcome with regard to a Clinical Composite Response and will be compared with MIRACLE-ICD outcome. The MOMIJI Study will also gather data on clinical profiles, clinical management such as hospitalization status, follow-up practices and events.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes To evaluate the clinical effectiveness of CRT-D device therapy in Japanese patients with Japanese criteria by comparing with pre-specified MIRACLE-ICD results
Key secondary outcomes 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.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key 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.
Key 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.
Target sample size 252

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Soichi Tsunoda
Organization Medtronic Japan, Co., Ltd.
Division name Cardiac Rhythm Disease Management, Clinical Research
Zip code
Address Tokyo
TEL 03-6430-7023
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tomoyuki Tejima
Organization Medtronic Japan, Co., Ltd.
Division name CRDM Clinical Research
Zip code
Address Tokyo
TEL 03-6430-7023
Homepage URL
Email tomoyuki.tejima@medtronic.com

Sponsor
Institute Medtronic Japan, Co., Ltd.
Institute
Department

Funding Source
Organization Medtronic Japan, Co., Ltd.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2007 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2006 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2007 Year 04 Month 01 Day
Last follow-up date
2010 Year 03 Month 01 Day
Date of closure to data entry
2010 Year 04 Month 01 Day
Date trial data considered complete
2010 Year 05 Month 01 Day
Date analysis concluded
2010 Year 05 Month 01 Day

Other
Other related information This study guarantees the ethical consideration for study participants as well as adherance to Japanese fair-trade law by conforming to the followings.
1. To Follow the declaration of Helsinki and the ethical guidelines for clinical studies, MHLW (No. 1228001, 30 July 2003, revised 28 December 2004).
2. To be approved by the IRB/MEC at each study center.
3. For all patients to be explained about the process of the study and use of private information. Notably, a written informed consent must be provided.
4. A bilateral sponsored research contract must be signed between Medtronic Japan and each study center, or, a trilateral contract including the CRO.

Management information
Registered date
2006 Year 12 Month 28 Day
Last modified on
2010 Year 10 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000678

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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