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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
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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.
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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 
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
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Time Frame No text entered.
Additional Description 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


Serious Adverse Events
    A - Standard ICD Programming   B - High Rate Cutoff   C - Long ICD Duration Delay
Total, serious adverse events       
# participants affected / at risk   446/514 (86.77%)   380/500 (76.00%)   394/486 (81.07%) 
Blood and lymphatic system disorders       
Hematological       
# participants affected / at risk   5/514 (0.97%)   3/500 (0.60%)   3/486 (0.62%) 
# events   7   3   3 
Hematoma       
# participants affected / at risk   1/514 (0.19%)   3/500 (0.60%)   1/486 (0.21%) 
# events   1   3   1 
Hemorrhage       
# participants affected / at risk   2/514 (0.39%)   1/500 (0.20%)   1/486 (0.21%) 
# events   2   1   1 
Thromboembolic events       
# participants affected / at risk   18/514 (3.50%)   18/500 (3.60%)   15/486 (3.09%) 
# events   20   18   16 
Cardiac disorders       
Extracardiac Stimulation, Left Ventricular       
# participants affected / at risk   0/514 (0.00%)   1/500 (0.20%)   3/486 (0.62%) 
# events   0   1   3 
Lead Dislodgment, Left Ventricular       
# participants affected / at risk   11/514 (2.14%)   7/500 (1.40%)   11/486 (2.26%) 
# events   11   7   11 
Threshold Related, Left Ventricular       
# participants affected / at risk   5/514 (0.97%)   1/500 (0.20%)   3/486 (0.62%) 
# events   5   1   3 
Pulse Generator-System, Patient-Other       
# participants affected / at risk   0/514 (0.00%)   0/500 (0.00%)   1/486 (0.21%) 
# events   0   0   1 
Pacemaker-mediated Tachycardia (PMT)       
# participants affected / at risk   2/514 (0.39%)   0/500 (0.00%)   1/486 (0.21%) 
# events   2   0   1 
Premature Ventricular Contractions (PVC)       
# participants affected / at risk   1/514 (0.19%)   0/500 (0.00%)   1/486 (0.21%) 
# events   1   0   1 
Unable to Communicate with Pulse Generator       
# participants affected / at risk   1/514 (0.19%)   0/500 (0.00%)   0/486 (0.00%) 
# events   1   0   0 
Elevated Threshold, Right Atrial       
# participants affected / at risk   0/514 (0.00%)   0/500 (0.00%)   1/486 (0.21%) 
# events   0   0   1 
Lead Dislodgment, Right Atrial       
# participants affected / at risk   7/514 (1.36%)   6/500 (1.20%)   5/486 (1.03%) 
# events   7   6   5 
Lead Related, Right Atrial       
# participants affected / at risk   2/514 (0.39%)   0/500 (0.00%)   0/486 (0.00%) 
# events   2   0   0 
Sensing Related, Right Atrial       
# participants affected / at risk   1/514 (0.19%)   0/500 (0.00%)   0/486 (0.00%) 
# events   1   0   0 
Lead Dislodgment, Right Ventricular       
# participants affected / at risk   1/514 (0.19%)   9/500 (1.80%)   5/486 (1.03%) 
# events   1   9   7 
Lead Related, Right Ventricular       
# participants affected / at risk   1/514 (0.19%)   2/500 (0.40%)   0/486 (0.00%) 
# events   1   2   0 
Sensing Related, Right Ventricular       
# participants affected / at risk   2/514 (0.39%)   1/500 (0.20%)   2/486 (0.41%) 
# events   2   1   2 
Threshold Related, Right Ventricular       
# participants affected / at risk   3/514 (0.58%)   5/500 (1.00%)   2/486 (0.41%) 
# events   3   5   2 
Cardiac Arrest       
# participants affected / at risk   4/514 (0.78%)   0/500 (0.00%)   2/486 (0.41%) 
# events   4   0   2 
Cardiogenic Shock       
# participants affected / at risk   1/514 (0.19%)   0/500 (0.00%)   1/486 (0.21%) 
# events   1   0   1 
Chest Pain, Ischemic       
# participants affected / at risk   2/514 (0.39%)   6/500 (1.20%)   15/486 (3.09%) 
# events   2   6   17 
Chest Pain, Other       
# participants affected / at risk   12/514 (2.33%)   16/500 (3.20%)   17/486 (3.50%) 
# events   15   17   18 
Pulse Generator Erosion       
# participants affected / at risk   3/514 (0.58%)   3/500 (0.60%)   1/486 (0.21%) 
# events   3   3   1 
Heart Failure Symptoms       
# participants affected / at risk   84/514 (16.34%)   67/500 (13.40%)   80/486 (16.46%) 
# events   141   111   130 
Hypertension       
# participants affected / at risk   2/514 (0.39%)   3/500 (0.60%)   1/486 (0.21%) 
# events   4   3   1 
Hypotension       
# participants affected / at risk   2/514 (0.39%)   2/500 (0.40%)   6/486 (1.23%) 
# events   2   3   6 
Inappropriate Tachy Therapy       
# participants affected / at risk   14/514 (2.72%)   5/500 (1.00%)   2/486 (0.41%) 
# events   15   5   2 
Inadvertant Tachy Arrhythmia       
# participants affected / at risk   1/514 (0.19%)   4/500 (0.80%)   2/486 (0.41%) 
# events   1   4   2 
Pulse Generator Migration       
# participants affected / at risk   0/514 (0.00%)   1/500 (0.20%)   0/486 (0.00%) 
# events   0   1   0 
Myocardial Infarction       
# participants affected / at risk   7/514 (1.36%)   5/500 (1.00%)   5/486 (1.03%) 
# events   8   6   5 
Cardiovascular, Patient Condition       
# participants affected / at risk   12/514 (2.33%)   11/500 (2.20%)   8/486 (1.65%) 
# events   13   13   10 
Palpitations       
# participants affected / at risk   0/514 (0.00%)   1/500 (0.20%)   1/486 (0.21%) 
# events   0   1   1 
Pericarditis       
# participants affected / at risk   1/514 (0.19%)   0/500 (0.00%)   0/486 (0.00%) 
# events   1   0   0 
Pericardial Effusion       
# participants affected / at risk   0/514 (0.00%)   2/500 (0.40%)   1/486 (0.21%) 
# events   0   2   1 
Supraventricular Tachy Arrhythmia       
# participants affected / at risk   20/514 (3.89%)   17/500 (3.40%)   22/486 (4.53%) 
# events   25   20   29 
Valvular Related       
# participants affected / at risk   1/514 (0.19%)   0/500 (0.00%)   1/486 (0.21%) 
# events   1   0   1 
Ventricular Arrhythmias       
# participants affected / at risk   26/514 (5.06%)   13/500 (2.60%)   15/486 (3.09%) 
# events   28   15   17 
Syncope, Cardiac Related       
# participants affected / at risk   4/514 (0.78%)   4/500 (0.80%)   4/486 (0.82%) 
# events   4   5   4 
Endocrine disorders       
Endocrine Related       
# participants affected / at risk   4/514 (0.78%)   3/500 (0.60%)   5/486 (1.03%) 
# events   4   3   8 
Gastrointestinal disorders       
Gastrointestinal Related       
# participants affected / at risk   28/514 (5.45%)   24/500 (4.80%)   25/486 (5.14%) 
# events   30   33   28 
General disorders       
Abnormal Laboratory Value       
# participants affected / at risk   5/514 (0.97%)   5/500 (1.00%)   5/486 (1.03%) 
# events   6   5   5 
Death [1]       
# participants affected / at risk   1/514 (0.19%)   4/500 (0.80%)   4/486 (0.82%) 
# events   1   4   4 
Dizziness       
# participants affected / at risk   3/514 (0.58%)   4/500 (0.80%)   2/486 (0.41%) 
# events   3   4   2 
Fatigue       
# participants affected / at risk   1/514 (0.19%)   1/500 (0.20%)   0/486 (0.00%) 
# events   1   1   0 
Fever       
# participants affected / at risk   1/514 (0.19%)   2/500 (0.40%)   3/486 (0.62%) 
# events   1   2   3 
Head, Eyes, Ears, Nose, Throat (HEENT)       
# participants affected / at risk   4/514 (0.78%)   3/500 (0.60%)   6/486 (1.23%) 
# events   4   3   6 
Multi-System Failure       
# participants affected / at risk   1/514 (0.19%)   1/500 (0.20%)   3/486 (0.62%) 
# events   1   1   3 
Related to Multiple Symptoms       
# participants affected / at risk   5/514 (0.97%)   0/500 (0.00%)   2/486 (0.41%) 
# events   5   0   2 
Non-Cardiovascular, Patient Condition       
# participants affected / at risk   2/514 (0.39%)   6/500 (1.20%)   5/486 (1.03%) 
# events   2   8   5 
Physical Trauma       
# participants affected / at risk   7/514 (1.36%)   5/500 (1.00%)   8/486 (1.65%) 
# events   7   5   8 
Psychological       
# participants affected / at risk   3/514 (0.58%)   1/500 (0.20%)   0/486 (0.00%) 
# events   3   1   0 
Cancer       
# participants affected / at risk   6/514 (1.17%)   5/500 (1.00%)   7/486 (1.44%) 
# events   6   5   8 
Syncope, General       
# participants affected / at risk   3/514 (0.58%)   4/500 (0.80%)   2/486 (0.41%) 
# events   3   4   2 
Immune system disorders       
Immune       
# participants affected / at risk   2/514 (0.39%)   0/500 (0.00%)   0/486 (0.00%) 
# events   2   0   0 
Infections and infestations       
Systemic Infection       
# participants affected / at risk   3/514 (0.58%)   6/500 (1.20%)   7/486 (1.44%) 
# events   3   6   7 
Musculoskeletal and connective tissue disorders       
Musculoskeletal       
# participants affected / at risk   15/514 (2.92%)   17/500 (3.40%)   10/486 (2.06%) 
# events   16   17   12 
Nervous system disorders       
Neurological       
# participants affected / at risk   8/514 (1.56%)   3/500 (0.60%)   5/486 (1.03%) 
# events   9   3   7 
Syncope, Neurological Related       
# participants affected / at risk   2/514 (0.39%)   1/500 (0.20%)   1/486 (0.21%) 
# events   2   1   2 
Renal and urinary disorders       
Genitourinary       
# participants affected / at risk   10/514 (1.95%)   7/500 (1.40%)   2/486 (0.41%) 
# events   12   7   3 
Renal       
# participants affected / at risk   14/514 (2.72%)   5/500 (1.00%)   7/486 (1.44%) 
# events   14   5   8 
Respiratory, thoracic and mediastinal disorders       
Dyspnea       
# participants affected / at risk   7/514 (1.36%)   7/500 (1.40%)   3/486 (0.62%) 
# events   10   7   3 
Pulmonary       
# participants affected / at risk   18/514 (3.50%)   20/500 (4.00%)   16/486 (3.29%) 
# events   22   22   16 
Skin and subcutaneous tissue disorders       
Integumentary       
# participants affected / at risk   2/514 (0.39%)   3/500 (0.60%)   3/486 (0.62%) 
# events   4   4   3 
Surgical and medical procedures       
Myocardial Perforation, Post-Implant, Right Ventricular       
# participants affected / at risk   0/514 (0.00%)   0/500 (0.00%)   1/486 (0.21%) 
# events   0   0   1 
Seroma, Pocket (<= 30 days Post Pulse Generator Implant)       
# participants affected / at risk   0/514 (0.00%)   1/500 (0.20%)   0/486 (0.00%) 
# events   0   1   0 
Adverse Reaction, Implant Procedure Related       
# participants affected / at risk   2/514 (0.39%)   4/500 (0.80%)   0/486 (0.00%) 
# events   3   5   0 
Bleeding, Implant Procedure Related       
# participants affected / at risk   5/514 (0.97%)   2/500 (0.40%)   2/486 (0.41%) 
# events   5   2   2 
Coronary Venous Trauma       
# participants affected / at risk   0/514 (0.00%)   0/500 (0.00%)   1/486 (0.21%) 
# events   0   0   1 
Hematoma, Pulse Generator Pocket (>30 days Post Device Implant)       
# participants affected / at risk   1/514 (0.19%)   0/500 (0.00%)   0/486 (0.00%) 
# events   1   0   0 
Infection, (> 30 days Post Device Implant)       
# participants affected / at risk   6/514 (1.17%)   5/500 (1.00%)   4/486 (0.82%) 
# events   6   5   4 
Pneumothorax, Procedure Related       
# participants affected / at risk   5/514 (0.97%)   5/500 (1.00%)   1/486 (0.21%) 
# events   5   5   1 
Post Surgical Wound Discomfort       
# participants affected / at risk   1/514 (0.19%)   1/500 (0.20%)   1/486 (0.21%) 
# events   1   1   1 
Post Surgical Infection (<= 30 days Post Device Implant)       
# participants affected / at risk   3/514 (0.58%)   4/500 (0.80%)   3/486 (0.62%) 
# events   3   4   3 
Post Surgical Pocket Hemorrhage       
# participants affected / at risk   1/514 (0.19%)   0/500 (0.00%)   0/486 (0.00%) 
# events   1   0   0 
Venous Occlusion       
# participants affected / at risk   1/514 (0.19%)   0/500 (0.00%)   1/486 (0.21%) 
# events   1   0   1 
Vascular disorders       
Vascular Related       
# participants affected / at risk   7/514 (1.36%)   4/500 (0.80%)   10/486 (2.06%) 
# events   10   4   11 
[1] This is not a complete listing of reported deaths, others are reported within other adverse event categories with a result in death.




  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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