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Multicenter Automatic Defibrillator Implantation Trial - Reduce Inappropriate Therapy (MADIT-RIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00947310
Recruitment Status : Completed
First Posted : July 28, 2009
Results First Posted : April 18, 2013
Last Update Posted : April 18, 2013
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Primary Prevention of Sudden Cardiac Arrest
Interventions: Device: Standard ICD programming
Device: High rate cutoff
Device: Long delay

  Participant Flow

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
A - Standard ICD Programming

Standard ICD Programming

Standard ICD programming : Standard ICD programming

B - High Rate Cutoff

High rate cutoff

High rate cutoff : Programming of a high rate cutoff

C - Long ICD Duration Delay

Long ICD duration delay

Long delay : Programming of a prolonged delay

Total Total of all reporting groups

Baseline Measures
   A - Standard ICD Programming   B - High Rate Cutoff   C - Long ICD Duration Delay   Total 
Overall Participants Analyzed 
[Units: Participants]
 514   500   486   1500 
[Units: Participants]
<=18 years   0   0   0   0 
Between 18 and 65 years   252   245   254   751 
>=65 years   262   255   232   749 
[Units: Years]
Mean (Standard Deviation)
 63  (11)   63  (12)   62  (12)   63  (12) 
[Units: Participants]
Female   157   146   133   436 
Male   357   354   353   1064 
Region of Enrollment 
[Units: Participants]
United States   353   338   325   1016 
Europe   94   92   91   277 
Japan   22   22   24   68 
Canada   11   12   12   35 
Israel   34   36   34   104 

  Outcome Measures

1.  Primary:   Inappropriate ICD Therapy   [ Time Frame: Average of 1.4 years follow-up ]

2.  Secondary:   All-cause Mortality   [ Time Frame: Average 1.4 years of follow-up ]

3.  Secondary:   Syncope   [ Time Frame: Average of 1.4 years follow-up ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information