Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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
  Hide 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.
No text entered.

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

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 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   252   245   254   751 
>=65 years   262   255   232   749 
Age 
[Units: Years]
Mean (Standard Deviation)
 63  (11)   63  (12)   62  (12)   63  (12) 
Gender 
[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
  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


  More Information