UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003056 |
|---|---|
| Receipt number | R000003702 |
| Scientific Title | Multicenter Automatic Defibrillator Implantation Trial - Reduce Inappropriate Therapy |
| Date of disclosure of the study information | 2010/01/19 |
| Last modified on | 2013/01/10 10:48:35 |
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Basic information
Public title
Multicenter Automatic Defibrillator Implantation Trial - Reduce Inappropriate Therapy
Acronym
MADIT-RIT
Scientific Title
Multicenter Automatic Defibrillator Implantation Trial - Reduce Inappropriate Therapy
Scientific Title:Acronym
MADIT-RIT
Region
| Japan | North America | Europe |
Condition
Condition
Primary Prevention of Sudden Cardiac Arrest that is limited to the approved Japanese ICD or CRT-D indications
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the MADIT-RIT trial is to compare the time to first inappropriate therapy using high rate cutoff and/or long delay in primary prevention patients receiving an ICD or CRT-D device compared to standard programming.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Time to first inappropriate therapy [ Time Frame: 12 months ]
Key secondary outcomes
All-cause mortality [ Time Frame: 12 months ] Syncope [ Time Frame: 12 months ]
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
1: Experimental
Standard ICD Programming
Interventions/Control_2
2: Experimental
Programming of a high rate cutoff
Interventions/Control_3
3: Experimental
Programming of a prolonged delay
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
| 21 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Primary prevention patient with ischemic or non-ischemic heart disease who meets current guidelines for dual-chamber ICD or CRT-D device therapy
2)Patient in sinus rhythm
3)Patient on stable optimal pharmacologic therapy for the cardiac condition or who has developed a recent ICD indication that necessitates ICD therapy concurrent with the optimization of pharmacologic therapy
4)Patient >21 years of age, or legal representative, willing and capable of giving informed consent
Patients who are fulfilling inclusion and exclusion criteria of the study as well as ICD or CRT-D indications
Key exclusion criteria
1)Patient with an implanted pacemaker or CRT-P
2)Patient with existing ICD or CRT-D device components
3)Patient with a history of spontaneous sustained VT or VF
4)Patient with permanent or chronic AF, or cardioversion for AF, within the past three calendar months before enrollment
5)Patient with coronary artery bypass graft surgery or percutaneous coronary intervention within the past three calendar months prior to enrollment
6)Patient with enzyme-positive myocardial infarction within the past three calendar months prior to enrollment
7)Patient with angiographic evidence of coronary disease who are candidates for coronary revascularization and are likely to undergo coronary artery bypass graft surgery or percutaneous coronary intervention in the foreseeable future
8)Patient with second or third degree heart block
9)Patient in NYHA Class IV
10)Patient who is pregnant or plans to become pregnant during the course of the trial
11)Patient with irreversible brain damage from p reexisting cerebral disease
12)Patient with presence of any disease, other than the patient's cardiac disease, associated with a reduced likelihood of survival for the duration of the trial, e.g., cancer, uremia, liver failure, etc.
13)Patient with chronic renal disease with BUN >50mg/dl or creatinine >2.5 mg/dl
14)Patient participating in any other clinical trial
15)Patient unwilling or unable to cooperate with the protocol
16)Patient who lives at such a distance from the clinic that travel for follow-up visits would be unusually difficult
17)Patient who does not anticipate being a resident of the area for the scheduled duration of the trial
18)Patient unwilling to sign the consent for participation
19)Patient whose physician does not allow participation
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Arthur J. Moss |
Organization
University of Rochester
Division name
University of Rochester Medical Center
Zip code
Address
601 Elmwood Avenue, Box 653
TEL
585-275-5391
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyoto University Graduate School of Medicine
Division name
Cardiovascular Medicine
Zip code
Address
TEL
075-751-3111
Homepage URL
Sponsor or person
Institute
University of Rochester
Institute
Department
Personal name
Funding Source
Organization
Boston Scientific Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
The United States
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT00947310
Org. issuing International ID_1
Clinicaltrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
京都大学医学部附属病院（京都府）、弘前大学医学部附属病院（青森県）、東京女子医科大学病院（東京都）、小倉記念病院（福岡県）、筑波大学附属病院（茨城県）、国立循環器病研究センター病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 01 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2009 | Year | 05 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 01 | Month | 19 | Day |
Last modified on
| 2013 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003702
