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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003056
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute University of Rochester
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003702

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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