UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000566 |
|---|---|
| Receipt number | 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 14:23:16 |
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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
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
tomoyuki.tejima@medtronic.com
Sponsor or person
Institute
Medtronic Japan, Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000678
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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