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

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.
 
ClinicalTrials.gov Identifier: NCT00947310
Recruitment Status : Completed
First Posted : July 28, 2009
Results First Posted : April 18, 2013
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

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
Enrollment 1500
Recruitment Details  
Pre-assignment Details  
Arm/Group Title A - Standard ICD Programming B - High Rate Cutoff C - Long ICD Duration Delay
Hide Arm/Group Description

Standard ICD Programming

Standard ICD programming : Standard ICD programming

High rate cutoff

High rate cutoff : Programming of a high rate cutoff

Long ICD duration delay

Long delay : Programming of a prolonged delay

Period Title: Overall Study
Started 514 500 486
Completed 514 500 486
Not Completed 0 0 0
Arm/Group Title A - Standard ICD Programming B - High Rate Cutoff C - Long ICD Duration Delay Total
Hide Arm/Group Description

Standard ICD Programming

Standard ICD programming : Standard ICD programming

High rate cutoff

High rate cutoff : Programming of a high rate cutoff

Long ICD duration delay

Long delay : Programming of a prolonged delay

Total of all reporting groups
Overall Number of Baseline Participants 514 500 486 1500
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 514 participants 500 participants 486 participants 1500 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
252
  49.0%
245
  49.0%
254
  52.3%
751
  50.1%
>=65 years
262
  51.0%
255
  51.0%
232
  47.7%
749
  49.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 514 participants 500 participants 486 participants 1500 participants
63  (11) 63  (12) 62  (12) 63  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 514 participants 500 participants 486 participants 1500 participants
Female
157
  30.5%
146
  29.2%
133
  27.4%
436
  29.1%
Male
357
  69.5%
354
  70.8%
353
  72.6%
1064
  70.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 514 participants 500 participants 486 participants 1500 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
1.Primary Outcome
Title Inappropriate ICD Therapy
Hide Description First occurance of inappropriate therapy (either anti-tachycardia pacing or shock)
Time Frame Average of 1.4 years follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A - Standard ICD Programming B - High Rate Cutoff C - Long ICD Duration Delay
Hide Arm/Group Description:

Standard ICD Programming

Standard ICD programming : Standard ICD programming

High rate cutoff

High rate cutoff : Programming of a high rate cutoff

Long ICD duration delay

Long delay : Programming of a prolonged delay

Overall Number of Participants Analyzed 514 500 486
Measure Type: Number
Unit of Measure: participants
105 21 26
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A - Standard ICD Programming, B - High Rate Cutoff
Comments Hazard ratios (HR) were calculated to compare Arm A vs Arm B. Null Hypothesis was that HR = 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.21
Confidence Interval (2-Sided) 95%
0.13 to 0.34
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection A - Standard ICD Programming, C - Long ICD Duration Delay
Comments Hazard ratios (HR) were calculated to compare Arm A vs Arm C. Null Hypothesis was that HR = 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.24
Confidence Interval (2-Sided) 95%
0.15 to 0.40
Estimation Comments [Not Specified]
2.Secondary Outcome
Title All-cause Mortality
Hide Description [Not Specified]
Time Frame Average 1.4 years of follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A - Standard ICD Programming B - High Rate Cutoff C - Long ICD Duration Delay
Hide Arm/Group Description:

Standard ICD Programming

Standard ICD programming : Standard ICD programming

High rate cutoff

High rate cutoff : Programming of a high rate cutoff

Long ICD duration delay

Long delay : Programming of a prolonged delay

Overall Number of Participants Analyzed 514 500 486
Measure Type: Number
Unit of Measure: participants
34 16 21
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A - Standard ICD Programming, B - High Rate Cutoff
Comments Hazard ratios (HR) were calculated to compare Arm A vs Arm B. Null Hypothesis was that HR = 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.45
Confidence Interval (2-Sided) 95%
0.24 to 0.85
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection A - Standard ICD Programming, C - Long ICD Duration Delay
Comments Hazard ratios (HR) were calculated to compare Arm A vs Arm C. Null Hypothesis was that HR = 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.56
Confidence Interval (2-Sided) 95%
0.30 to 1.02
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Syncope
Hide Description First episode of syncope
Time Frame Average of 1.4 years follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A - Standard ICD Programming B - High Rate Cutoff C - Long ICD Duration Delay
Hide Arm/Group Description:

Standard ICD Programming

Standard ICD programming : Standard ICD programming

High rate cutoff

High rate cutoff : Programming of a high rate cutoff

Long ICD duration delay

Long delay : Programming of a prolonged delay

Overall Number of Participants Analyzed 514 500 486
Measure Type: Number
Unit of Measure: participants
23 22 22
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A - Standard ICD Programming, B - High Rate Cutoff
Comments Hazard ratios (HR) were calculated to compare Arm A vs Arm B. Null Hypothesis was that HR = 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.39
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.32
Confidence Interval (2-Sided) 95%
0.71 to 2.47
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection A - Standard ICD Programming, C - Long ICD Duration Delay
Comments Hazard ratios (HR) were calculated to compare Arm A vs Arm C. Null Hypothesis was that HR = 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.80
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.58 to 2.05
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title A - Standard ICD Programming B - High Rate Cutoff C - Long ICD Duration Delay
Hide Arm/Group Description

Standard ICD Programming

Standard ICD programming : Standard ICD programming

High rate cutoff

High rate cutoff : Programming of a high rate cutoff

Long ICD duration delay

Long delay : Programming of a prolonged delay

All-Cause Mortality
A - Standard ICD Programming B - High Rate Cutoff C - Long ICD Duration Delay
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
A - Standard ICD Programming B - High Rate Cutoff C - Long ICD Duration Delay
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   446/514 (86.77%)      380/500 (76.00%)      394/486 (81.07%)    
Blood and lymphatic system disorders       
Hematological  5/514 (0.97%)  7 3/500 (0.60%)  3 3/486 (0.62%)  3
Hematoma  1/514 (0.19%)  1 3/500 (0.60%)  3 1/486 (0.21%)  1
Hemorrhage  2/514 (0.39%)  2 1/500 (0.20%)  1 1/486 (0.21%)  1
Thromboembolic events  18/514 (3.50%)  20 18/500 (3.60%)  18 15/486 (3.09%)  16
Cardiac disorders       
Extracardiac Stimulation, Left Ventricular  0/514 (0.00%)  0 1/500 (0.20%)  1 3/486 (0.62%)  3
Lead Dislodgment, Left Ventricular  11/514 (2.14%)  11 7/500 (1.40%)  7 11/486 (2.26%)  11
Threshold Related, Left Ventricular  5/514 (0.97%)  5 1/500 (0.20%)  1 3/486 (0.62%)  3
Pulse Generator-System, Patient-Other  0/514 (0.00%)  0 0/500 (0.00%)  0 1/486 (0.21%)  1
Pacemaker-mediated Tachycardia (PMT)  2/514 (0.39%)  2 0/500 (0.00%)  0 1/486 (0.21%)  1
Premature Ventricular Contractions (PVC)  1/514 (0.19%)  1 0/500 (0.00%)  0 1/486 (0.21%)  1
Unable to Communicate with Pulse Generator  1/514 (0.19%)  1 0/500 (0.00%)  0 0/486 (0.00%)  0
Elevated Threshold, Right Atrial  0/514 (0.00%)  0 0/500 (0.00%)  0 1/486 (0.21%)  1
Lead Dislodgment, Right Atrial  7/514 (1.36%)  7 6/500 (1.20%)  6 5/486 (1.03%)  5
Lead Related, Right Atrial  2/514 (0.39%)  2 0/500 (0.00%)  0 0/486 (0.00%)  0
Sensing Related, Right Atrial  1/514 (0.19%)  1 0/500 (0.00%)  0 0/486 (0.00%)  0
Lead Dislodgment, Right Ventricular  1/514 (0.19%)  1 9/500 (1.80%)  9 5/486 (1.03%)  7
Lead Related, Right Ventricular  1/514 (0.19%)  1 2/500 (0.40%)  2 0/486 (0.00%)  0
Sensing Related, Right Ventricular  2/514 (0.39%)  2 1/500 (0.20%)  1 2/486 (0.41%)  2
Threshold Related, Right Ventricular  3/514 (0.58%)  3 5/500 (1.00%)  5 2/486 (0.41%)  2
Cardiac Arrest  4/514 (0.78%)  4 0/500 (0.00%)  0 2/486 (0.41%)  2
Cardiogenic Shock  1/514 (0.19%)  1 0/500 (0.00%)  0 1/486 (0.21%)  1
Chest Pain, Ischemic  2/514 (0.39%)  2 6/500 (1.20%)  6 15/486 (3.09%)  17
Chest Pain, Other  12/514 (2.33%)  15 16/500 (3.20%)  17 17/486 (3.50%)  18
Pulse Generator Erosion  3/514 (0.58%)  3 3/500 (0.60%)  3 1/486 (0.21%)  1
Heart Failure Symptoms  84/514 (16.34%)  141 67/500 (13.40%)  111 80/486 (16.46%)  130
Hypertension  2/514 (0.39%)  4 3/500 (0.60%)  3 1/486 (0.21%)  1
Hypotension  2/514 (0.39%)  2 2/500 (0.40%)  3 6/486 (1.23%)  6
Inappropriate Tachy Therapy  14/514 (2.72%)  15 5/500 (1.00%)  5 2/486 (0.41%)  2
Inadvertant Tachy Arrhythmia  1/514 (0.19%)  1 4/500 (0.80%)  4 2/486 (0.41%)  2
Pulse Generator Migration  0/514 (0.00%)  0 1/500 (0.20%)  1 0/486 (0.00%)  0
Myocardial Infarction  7/514 (1.36%)  8 5/500 (1.00%)  6 5/486 (1.03%)  5
Cardiovascular, Patient Condition  12/514 (2.33%)  13 11/500 (2.20%)  13 8/486 (1.65%)  10
Palpitations  0/514 (0.00%)  0 1/500 (0.20%)  1 1/486 (0.21%)  1
Pericarditis  1/514 (0.19%)  1 0/500 (0.00%)  0 0/486 (0.00%)  0
Pericardial Effusion  0/514 (0.00%)  0 2/500 (0.40%)  2 1/486 (0.21%)  1
Supraventricular Tachy Arrhythmia  20/514 (3.89%)  25 17/500 (3.40%)  20 22/486 (4.53%)  29
Valvular Related  1/514 (0.19%)  1 0/500 (0.00%)  0 1/486 (0.21%)  1
Ventricular Arrhythmias  26/514 (5.06%)  28 13/500 (2.60%)  15 15/486 (3.09%)  17
Syncope, Cardiac Related  4/514 (0.78%)  4 4/500 (0.80%)  5 4/486 (0.82%)  4
Endocrine disorders       
Endocrine Related  4/514 (0.78%)  4 3/500 (0.60%)  3 5/486 (1.03%)  8
Gastrointestinal disorders       
Gastrointestinal Related  28/514 (5.45%)  30 24/500 (4.80%)  33 25/486 (5.14%)  28
General disorders       
Abnormal Laboratory Value  5/514 (0.97%)  6 5/500 (1.00%)  5 5/486 (1.03%)  5
Death [1]  1/514 (0.19%)  1 4/500 (0.80%)  4 4/486 (0.82%)  4
Dizziness  3/514 (0.58%)  3 4/500 (0.80%)  4 2/486 (0.41%)  2
Fatigue  1/514 (0.19%)  1 1/500 (0.20%)  1 0/486 (0.00%)  0
Fever  1/514 (0.19%)  1 2/500 (0.40%)  2 3/486 (0.62%)  3
Head, Eyes, Ears, Nose, Throat (HEENT)  4/514 (0.78%)  4 3/500 (0.60%)  3 6/486 (1.23%)  6
Multi-System Failure  1/514 (0.19%)  1 1/500 (0.20%)  1 3/486 (0.62%)  3
Related to Multiple Symptoms  5/514 (0.97%)  5 0/500 (0.00%)  0 2/486 (0.41%)  2
Non-Cardiovascular, Patient Condition  2/514 (0.39%)  2 6/500 (1.20%)  8 5/486 (1.03%)  5
Physical Trauma  7/514 (1.36%)  7 5/500 (1.00%)  5 8/486 (1.65%)  8
Psychological  3/514 (0.58%)  3 1/500 (0.20%)  1 0/486 (0.00%)  0
Cancer  6/514 (1.17%)  6 5/500 (1.00%)  5 7/486 (1.44%)  8
Syncope, General  3/514 (0.58%)  3 4/500 (0.80%)  4 2/486 (0.41%)  2
Immune system disorders       
Immune  2/514 (0.39%)  2 0/500 (0.00%)  0 0/486 (0.00%)  0
Infections and infestations       
Systemic Infection  3/514 (0.58%)  3 6/500 (1.20%)  6 7/486 (1.44%)  7
Musculoskeletal and connective tissue disorders       
Musculoskeletal  15/514 (2.92%)  16 17/500 (3.40%)  17 10/486 (2.06%)  12
Nervous system disorders       
Neurological  8/514 (1.56%)  9 3/500 (0.60%)  3 5/486 (1.03%)  7
Syncope, Neurological Related  2/514 (0.39%)  2 1/500 (0.20%)  1 1/486 (0.21%)  2
Renal and urinary disorders       
Genitourinary  10/514 (1.95%)  12 7/500 (1.40%)  7 2/486 (0.41%)  3
Renal  14/514 (2.72%)  14 5/500 (1.00%)  5 7/486 (1.44%)  8
Respiratory, thoracic and mediastinal disorders       
Dyspnea  7/514 (1.36%)  10 7/500 (1.40%)  7 3/486 (0.62%)  3
Pulmonary  18/514 (3.50%)  22 20/500 (4.00%)  22 16/486 (3.29%)  16
Skin and subcutaneous tissue disorders       
Integumentary  2/514 (0.39%)  4 3/500 (0.60%)  4 3/486 (0.62%)  3
Surgical and medical procedures       
Myocardial Perforation, Post-Implant, Right Ventricular  0/514 (0.00%)  0 0/500 (0.00%)  0 1/486 (0.21%)  1
Seroma, Pocket (<= 30 days Post Pulse Generator Implant)  0/514 (0.00%)  0 1/500 (0.20%)  1 0/486 (0.00%)  0
Adverse Reaction, Implant Procedure Related  2/514 (0.39%)  3 4/500 (0.80%)  5 0/486 (0.00%)  0
Bleeding, Implant Procedure Related  5/514 (0.97%)  5 2/500 (0.40%)  2 2/486 (0.41%)  2
Coronary Venous Trauma  0/514 (0.00%)  0 0/500 (0.00%)  0 1/486 (0.21%)  1
Hematoma, Pulse Generator Pocket (>30 days Post Device Implant)  1/514 (0.19%)  1 0/500 (0.00%)  0 0/486 (0.00%)  0
Infection, (> 30 days Post Device Implant)  6/514 (1.17%)  6 5/500 (1.00%)  5 4/486 (0.82%)  4
Pneumothorax, Procedure Related  5/514 (0.97%)  5 5/500 (1.00%)  5 1/486 (0.21%)  1
Post Surgical Wound Discomfort  1/514 (0.19%)  1 1/500 (0.20%)  1 1/486 (0.21%)  1
Post Surgical Infection (<= 30 days Post Device Implant)  3/514 (0.58%)  3 4/500 (0.80%)  4 3/486 (0.62%)  3
Post Surgical Pocket Hemorrhage  1/514 (0.19%)  1 0/500 (0.00%)  0 0/486 (0.00%)  0
Venous Occlusion  1/514 (0.19%)  1 0/500 (0.00%)  0 1/486 (0.21%)  1
Vascular disorders       
Vascular Related  7/514 (1.36%)  10 4/500 (0.80%)  4 10/486 (2.06%)  11
[1]
This is not a complete listing of reported deaths, others are reported within other adverse event categories with a result in death.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
A - Standard ICD Programming B - High Rate Cutoff C - Long ICD Duration Delay
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   207/514 (40.27%)      136/500 (27.20%)      121/486 (24.90%)    
Cardiac disorders       
Extracardiac Stimulation, Left Ventricular  32/514 (6.23%)  38 26/500 (5.20%)  28 24/486 (4.94%)  25
Heart Failure Symptoms  34/514 (6.61%)  44 32/500 (6.40%)  37 35/486 (7.20%)  39
Inappropriate Tachy Therapy  85/514 (16.54%)  103 0/500 (0.00%)  0 20/486 (4.12%)  24
Pacemaker-mediated Tachycardia (PMT)  0/514 (0.00%)  0 29/500 (5.80%)  30 20/486 (4.12%)  22
Supraventricular Tachy Arrhythmia  30/514 (5.84%)  34 29/500 (5.80%)  30 22/486 (4.53%)  25
Ventricular Tachyarrhythmia  26/514 (5.06%)  32 20/500 (4.00%)  22 0/486 (0.00%)  0
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Arthur J. Moss
Organization: University of Rochester, Heart Research Follow-up Program
Phone: 585-275-5391
EMail: arthur.moss@heart.rochester.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00947310    
Other Study ID Numbers: MADIT-RIT
First Submitted: July 27, 2009
First Posted: July 28, 2009
Results First Submitted: March 4, 2013
Results First Posted: April 18, 2013
Last Update Posted: August 8, 2018