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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
History of Changes
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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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 ]
  Show Outcome Measure 1

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

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


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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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Results Point of Contact:  
Name/Title: Dr. Arthur J. Moss
Organization: University of Rochester, Heart Research Follow-up Program
phone: 585-275-5391
e-mail: arthur.moss@heart.rochester.edu


Publications:

Publications automatically indexed to this study:


Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00947310     History of Changes
Other Study ID Numbers: MADIT-RIT
Study First Received: July 27, 2009
Results First Received: March 4, 2013
Last Updated: March 4, 2013
Health Authority: United States: Institutional Review Board