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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00947310
First Posted: July 28, 2009
Last Update Posted: April 18, 2013
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.
Information provided by (Responsible Party):
Boston Scientific Corporation
Results First Submitted: March 4, 2013  
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
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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 ]

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
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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


Other Adverse Events
    A - Standard ICD Programming   B - High Rate Cutoff   C - Long ICD Duration Delay
Total, Other (not including serious) Adverse Events       
# participants affected / at risk   207/514 (40.27%)   136/500 (27.20%)   121/486 (24.90%) 
Cardiac disorders       
Extracardiac Stimulation, Left Ventricular       
# participants affected / at risk   32/514 (6.23%)   26/500 (5.20%)   24/486 (4.94%) 
# events   38   28   25 
Heart Failure Symptoms       
# participants affected / at risk   34/514 (6.61%)   32/500 (6.40%)   35/486 (7.20%) 
# events   44   37   39 
Inappropriate Tachy Therapy       
# participants affected / at risk   85/514 (16.54%)   0/500 (0.00%)   20/486 (4.12%) 
# events   103   0   24 
Pacemaker-mediated Tachycardia (PMT)       
# participants affected / at risk   0/514 (0.00%)   29/500 (5.80%)   20/486 (4.12%) 
# events   0   30   22 
Supraventricular Tachy Arrhythmia       
# participants affected / at risk   30/514 (5.84%)   29/500 (5.80%)   22/486 (4.53%) 
# events   34   30   25 
Ventricular Tachyarrhythmia       
# participants affected / at risk   26/514 (5.06%)   20/500 (4.00%)   0/486 (0.00%) 
# events   32   22   0 



  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