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
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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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