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

Measure Type Primary
Measure Title Inappropriate ICD Therapy
Measure Description First occurance of inappropriate therapy (either anti-tachycardia pacing or shock)
Time Frame Average of 1.4 years follow-up  
Safety Issue No  

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


Measured Values
   A - Standard ICD Programming   B - High Rate Cutoff   C - Long ICD Duration Delay 
Participants Analyzed 
[Units: Participants]
 514   500   486 
Inappropriate ICD Therapy 
[Units: Participants]
 105   21   26 


Statistical Analysis 1 for Inappropriate ICD Therapy
Groups [1] A - Standard ICD Programming vs. B - High Rate Cutoff
Method [2] Regression, Cox
P Value [3] <0.001
Hazard Ratio (HR) [4] 0.21
95% Confidence Interval 0.13 to 0.34
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Hazard ratios (HR) were calculated to compare Arm A vs Arm B. Null Hypothesis was that HR = 1
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Inappropriate ICD Therapy
Groups [1] A - Standard ICD Programming vs. C - Long ICD Duration Delay
Method [2] Regression, Cox
P Value [3] <0.001
Hazard Ratio (HR) [4] 0.24
95% Confidence Interval 0.15 to 0.40
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Hazard ratios (HR) were calculated to compare Arm A vs Arm C. Null Hypothesis was that HR = 1
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



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

Measure Type Secondary
Measure Title All-cause Mortality
Measure Description No text entered.
Time Frame Average 1.4 years of follow-up  
Safety Issue Yes  

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


Measured Values
   A - Standard ICD Programming   B - High Rate Cutoff   C - Long ICD Duration Delay 
Participants Analyzed 
[Units: Participants]
 514   500   486 
All-cause Mortality 
[Units: Participants]
 34   16   21 


Statistical Analysis 1 for All-cause Mortality
Groups [1] A - Standard ICD Programming vs. B - High Rate Cutoff
Method [2] Regression, Cox
P Value [3] 0.01
Hazard Ratio (HR) [4] 0.45
95% Confidence Interval 0.24 to 0.85
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Hazard ratios (HR) were calculated to compare Arm A vs Arm B. Null Hypothesis was that HR = 1
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for All-cause Mortality
Groups [1] A - Standard ICD Programming vs. C - Long ICD Duration Delay
Method [2] Regression, Cox
P Value [3] 0.06
Hazard Ratio (HR) [4] 0.56
95% Confidence Interval 0.30 to 1.02
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Hazard ratios (HR) were calculated to compare Arm A vs Arm C. Null Hypothesis was that HR = 1
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



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

Measure Type Secondary
Measure Title Syncope
Measure Description First episode of syncope
Time Frame Average of 1.4 years follow-up  
Safety Issue Yes  

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


Measured Values
   A - Standard ICD Programming   B - High Rate Cutoff   C - Long ICD Duration Delay 
Participants Analyzed 
[Units: Participants]
 514   500   486 
Syncope 
[Units: Participants]
 23   22   22 


Statistical Analysis 1 for Syncope
Groups [1] A - Standard ICD Programming vs. B - High Rate Cutoff
Method [2] Regression, Cox
P Value [3] 0.39
Hazard Ratio (HR) [4] 1.32
95% Confidence Interval 0.71 to 2.47
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Hazard ratios (HR) were calculated to compare Arm A vs Arm B. Null Hypothesis was that HR = 1
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Syncope
Groups [1] A - Standard ICD Programming vs. C - Long ICD Duration Delay
Method [2] Regression, Cox
P Value [3] 0.80
Hazard Ratio (HR) [4] 1.09
95% Confidence Interval 0.58 to 2.05
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Hazard ratios (HR) were calculated to compare Arm A vs Arm C. Null Hypothesis was that HR = 1
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.




  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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  More Information