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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00947310
First received: July 27, 2009
Last updated: March 4, 2013
Last verified: March 2013
Results First Received: March 4, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Primary Prevention of Sudden Cardiac Arrest
Interventions: Device: Standard ICD programming
Device: High rate cutoff
Device: Long delay

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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


Participant Flow:   Overall Study
    A - Standard ICD Programming     B - High Rate Cutoff     C - Long ICD Duration Delay  
STARTED     514     500     486  
COMPLETED     514     500     486  
NOT COMPLETED     0     0     0  



  Baseline Characteristics


  Outcome Measures
  Show All 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
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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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