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

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ClinicalTrials.gov Identifier: NCT00947310
Recruitment Status : Completed
First Posted : July 28, 2009
Results First Posted : April 18, 2013
Last Update Posted : April 18, 2013
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

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

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

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