Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
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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.
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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

Total Total of all reporting groups

Baseline Measures
    A - Standard ICD Programming     B - High Rate Cutoff     C - Long ICD Duration Delay     Total  
Number of Participants  
[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     136/500     121/486  
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