Trial Outcomes & Findings for Multicenter Automatic Defibrillator Implantation Trial - Reduce Inappropriate Therapy (NCT NCT00947310)
NCT ID: NCT00947310
Last Updated: 2018-08-08
Results Overview
First occurance of inappropriate therapy (either anti-tachycardia pacing or shock)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1500 participants
Primary outcome timeframe
Average of 1.4 years follow-up
Results posted on
2018-08-08
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
514
|
500
|
486
|
|
Overall Study
COMPLETED
|
514
|
500
|
486
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Multicenter Automatic Defibrillator Implantation Trial - Reduce Inappropriate Therapy
Baseline characteristics by cohort
| Measure |
A - Standard ICD Programming
n=514 Participants
Standard ICD Programming
Standard ICD programming : Standard ICD programming
|
B - High Rate Cutoff
n=500 Participants
High rate cutoff
High rate cutoff : Programming of a high rate cutoff
|
C - Long ICD Duration Delay
n=486 Participants
Long ICD duration delay
Long delay : Programming of a prolonged delay
|
Total
n=1500 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
252 Participants
n=5 Participants
|
245 Participants
n=7 Participants
|
254 Participants
n=5 Participants
|
751 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
262 Participants
n=5 Participants
|
255 Participants
n=7 Participants
|
232 Participants
n=5 Participants
|
749 Participants
n=4 Participants
|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 11 • n=5 Participants
|
63 years
STANDARD_DEVIATION 12 • n=7 Participants
|
62 years
STANDARD_DEVIATION 12 • n=5 Participants
|
63 years
STANDARD_DEVIATION 12 • n=4 Participants
|
|
Sex: Female, Male
Female
|
157 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
436 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
357 Participants
n=5 Participants
|
354 Participants
n=7 Participants
|
353 Participants
n=5 Participants
|
1064 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
353 participants
n=5 Participants
|
338 participants
n=7 Participants
|
325 participants
n=5 Participants
|
1016 participants
n=4 Participants
|
|
Region of Enrollment
Europe
|
94 participants
n=5 Participants
|
92 participants
n=7 Participants
|
91 participants
n=5 Participants
|
277 participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
22 participants
n=5 Participants
|
22 participants
n=7 Participants
|
24 participants
n=5 Participants
|
68 participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
11 participants
n=5 Participants
|
12 participants
n=7 Participants
|
12 participants
n=5 Participants
|
35 participants
n=4 Participants
|
|
Region of Enrollment
Israel
|
34 participants
n=5 Participants
|
36 participants
n=7 Participants
|
34 participants
n=5 Participants
|
104 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Average of 1.4 years follow-upFirst occurance of inappropriate therapy (either anti-tachycardia pacing or shock)
Outcome measures
| Measure |
A - Standard ICD Programming
n=514 Participants
Standard ICD Programming
Standard ICD programming : Standard ICD programming
|
B - High Rate Cutoff
n=500 Participants
High rate cutoff
High rate cutoff : Programming of a high rate cutoff
|
C - Long ICD Duration Delay
n=486 Participants
Long ICD duration delay
Long delay : Programming of a prolonged delay
|
|---|---|---|---|
|
Inappropriate ICD Therapy
|
105 participants
|
21 participants
Interval 0.13 to 0.34
|
26 participants
Interval 0.15 to 0.4
|
SECONDARY outcome
Timeframe: Average 1.4 years of follow-upOutcome measures
| Measure |
A - Standard ICD Programming
n=514 Participants
Standard ICD Programming
Standard ICD programming : Standard ICD programming
|
B - High Rate Cutoff
n=500 Participants
High rate cutoff
High rate cutoff : Programming of a high rate cutoff
|
C - Long ICD Duration Delay
n=486 Participants
Long ICD duration delay
Long delay : Programming of a prolonged delay
|
|---|---|---|---|
|
All-cause Mortality
|
34 participants
|
16 participants
|
21 participants
|
SECONDARY outcome
Timeframe: Average of 1.4 years follow-upFirst episode of syncope
Outcome measures
| Measure |
A - Standard ICD Programming
n=514 Participants
Standard ICD Programming
Standard ICD programming : Standard ICD programming
|
B - High Rate Cutoff
n=500 Participants
High rate cutoff
High rate cutoff : Programming of a high rate cutoff
|
C - Long ICD Duration Delay
n=486 Participants
Long ICD duration delay
Long delay : Programming of a prolonged delay
|
|---|---|---|---|
|
Syncope
|
23 participants
|
22 participants
|
22 participants
|
Adverse Events
A - Standard ICD Programming
Serious events: 446 serious events
Other events: 207 other events
Deaths: 0 deaths
B - High Rate Cutoff
Serious events: 380 serious events
Other events: 136 other events
Deaths: 0 deaths
C - Long ICD Duration Delay
Serious events: 394 serious events
Other events: 121 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
A - Standard ICD Programming
n=514 participants at risk
Standard ICD Programming
Standard ICD programming : Standard ICD programming
|
B - High Rate Cutoff
n=500 participants at risk
High rate cutoff
High rate cutoff : Programming of a high rate cutoff
|
C - Long ICD Duration Delay
n=486 participants at risk
Long ICD duration delay
Long delay : Programming of a prolonged delay
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Hematological
|
0.97%
5/514 • Number of events 7
|
0.60%
3/500 • Number of events 3
|
0.62%
3/486 • Number of events 3
|
|
Blood and lymphatic system disorders
Hematoma
|
0.19%
1/514 • Number of events 1
|
0.60%
3/500 • Number of events 3
|
0.21%
1/486 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemorrhage
|
0.39%
2/514 • Number of events 2
|
0.20%
1/500 • Number of events 1
|
0.21%
1/486 • Number of events 1
|
|
Blood and lymphatic system disorders
Thromboembolic events
|
3.5%
18/514 • Number of events 20
|
3.6%
18/500 • Number of events 18
|
3.1%
15/486 • Number of events 16
|
|
Cardiac disorders
Extracardiac Stimulation, Left Ventricular
|
0.00%
0/514
|
0.20%
1/500 • Number of events 1
|
0.62%
3/486 • Number of events 3
|
|
Cardiac disorders
Lead Dislodgment, Left Ventricular
|
2.1%
11/514 • Number of events 11
|
1.4%
7/500 • Number of events 7
|
2.3%
11/486 • Number of events 11
|
|
Cardiac disorders
Threshold Related, Left Ventricular
|
0.97%
5/514 • Number of events 5
|
0.20%
1/500 • Number of events 1
|
0.62%
3/486 • Number of events 3
|
|
Cardiac disorders
Pulse Generator-System, Patient-Other
|
0.00%
0/514
|
0.00%
0/500
|
0.21%
1/486 • Number of events 1
|
|
Cardiac disorders
Pacemaker-mediated Tachycardia (PMT)
|
0.39%
2/514 • Number of events 2
|
0.00%
0/500
|
0.21%
1/486 • Number of events 1
|
|
Cardiac disorders
Premature Ventricular Contractions (PVC)
|
0.19%
1/514 • Number of events 1
|
0.00%
0/500
|
0.21%
1/486 • Number of events 1
|
|
Cardiac disorders
Unable to Communicate with Pulse Generator
|
0.19%
1/514 • Number of events 1
|
0.00%
0/500
|
0.00%
0/486
|
|
Cardiac disorders
Elevated Threshold, Right Atrial
|
0.00%
0/514
|
0.00%
0/500
|
0.21%
1/486 • Number of events 1
|
|
Cardiac disorders
Lead Dislodgment, Right Atrial
|
1.4%
7/514 • Number of events 7
|
1.2%
6/500 • Number of events 6
|
1.0%
5/486 • Number of events 5
|
|
Cardiac disorders
Lead Related, Right Atrial
|
0.39%
2/514 • Number of events 2
|
0.00%
0/500
|
0.00%
0/486
|
|
Cardiac disorders
Sensing Related, Right Atrial
|
0.19%
1/514 • Number of events 1
|
0.00%
0/500
|
0.00%
0/486
|
|
Cardiac disorders
Lead Dislodgment, Right Ventricular
|
0.19%
1/514 • Number of events 1
|
1.8%
9/500 • Number of events 9
|
1.0%
5/486 • Number of events 7
|
|
Cardiac disorders
Lead Related, Right Ventricular
|
0.19%
1/514 • Number of events 1
|
0.40%
2/500 • Number of events 2
|
0.00%
0/486
|
|
Cardiac disorders
Sensing Related, Right Ventricular
|
0.39%
2/514 • Number of events 2
|
0.20%
1/500 • Number of events 1
|
0.41%
2/486 • Number of events 2
|
|
Cardiac disorders
Threshold Related, Right Ventricular
|
0.58%
3/514 • Number of events 3
|
1.0%
5/500 • Number of events 5
|
0.41%
2/486 • Number of events 2
|
|
Cardiac disorders
Cardiac Arrest
|
0.78%
4/514 • Number of events 4
|
0.00%
0/500
|
0.41%
2/486 • Number of events 2
|
|
Cardiac disorders
Cardiogenic Shock
|
0.19%
1/514 • Number of events 1
|
0.00%
0/500
|
0.21%
1/486 • Number of events 1
|
|
Cardiac disorders
Chest Pain, Ischemic
|
0.39%
2/514 • Number of events 2
|
1.2%
6/500 • Number of events 6
|
3.1%
15/486 • Number of events 17
|
|
Cardiac disorders
Chest Pain, Other
|
2.3%
12/514 • Number of events 15
|
3.2%
16/500 • Number of events 17
|
3.5%
17/486 • Number of events 18
|
|
Cardiac disorders
Pulse Generator Erosion
|
0.58%
3/514 • Number of events 3
|
0.60%
3/500 • Number of events 3
|
0.21%
1/486 • Number of events 1
|
|
Cardiac disorders
Heart Failure Symptoms
|
16.3%
84/514 • Number of events 141
|
13.4%
67/500 • Number of events 111
|
16.5%
80/486 • Number of events 130
|
|
Cardiac disorders
Hypertension
|
0.39%
2/514 • Number of events 4
|
0.60%
3/500 • Number of events 3
|
0.21%
1/486 • Number of events 1
|
|
Cardiac disorders
Hypotension
|
0.39%
2/514 • Number of events 2
|
0.40%
2/500 • Number of events 3
|
1.2%
6/486 • Number of events 6
|
|
Cardiac disorders
Inappropriate Tachy Therapy
|
2.7%
14/514 • Number of events 15
|
1.0%
5/500 • Number of events 5
|
0.41%
2/486 • Number of events 2
|
|
Cardiac disorders
Inadvertant Tachy Arrhythmia
|
0.19%
1/514 • Number of events 1
|
0.80%
4/500 • Number of events 4
|
0.41%
2/486 • Number of events 2
|
|
Cardiac disorders
Pulse Generator Migration
|
0.00%
0/514
|
0.20%
1/500 • Number of events 1
|
0.00%
0/486
|
|
Cardiac disorders
Myocardial Infarction
|
1.4%
7/514 • Number of events 8
|
1.0%
5/500 • Number of events 6
|
1.0%
5/486 • Number of events 5
|
|
Cardiac disorders
Cardiovascular, Patient Condition
|
2.3%
12/514 • Number of events 13
|
2.2%
11/500 • Number of events 13
|
1.6%
8/486 • Number of events 10
|
|
Cardiac disorders
Palpitations
|
0.00%
0/514
|
0.20%
1/500 • Number of events 1
|
0.21%
1/486 • Number of events 1
|
|
Cardiac disorders
Pericarditis
|
0.19%
1/514 • Number of events 1
|
0.00%
0/500
|
0.00%
0/486
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/514
|
0.40%
2/500 • Number of events 2
|
0.21%
1/486 • Number of events 1
|
|
Cardiac disorders
Supraventricular Tachy Arrhythmia
|
3.9%
20/514 • Number of events 25
|
3.4%
17/500 • Number of events 20
|
4.5%
22/486 • Number of events 29
|
|
Cardiac disorders
Valvular Related
|
0.19%
1/514 • Number of events 1
|
0.00%
0/500
|
0.21%
1/486 • Number of events 1
|
|
Cardiac disorders
Ventricular Arrhythmias
|
5.1%
26/514 • Number of events 28
|
2.6%
13/500 • Number of events 15
|
3.1%
15/486 • Number of events 17
|
|
Cardiac disorders
Syncope, Cardiac Related
|
0.78%
4/514 • Number of events 4
|
0.80%
4/500 • Number of events 5
|
0.82%
4/486 • Number of events 4
|
|
Endocrine disorders
Endocrine Related
|
0.78%
4/514 • Number of events 4
|
0.60%
3/500 • Number of events 3
|
1.0%
5/486 • Number of events 8
|
|
Gastrointestinal disorders
Gastrointestinal Related
|
5.4%
28/514 • Number of events 30
|
4.8%
24/500 • Number of events 33
|
5.1%
25/486 • Number of events 28
|
|
General disorders
Abnormal Laboratory Value
|
0.97%
5/514 • Number of events 6
|
1.0%
5/500 • Number of events 5
|
1.0%
5/486 • Number of events 5
|
|
General disorders
Death
|
0.19%
1/514 • Number of events 1
|
0.80%
4/500 • Number of events 4
|
0.82%
4/486 • Number of events 4
|
|
General disorders
Dizziness
|
0.58%
3/514 • Number of events 3
|
0.80%
4/500 • Number of events 4
|
0.41%
2/486 • Number of events 2
|
|
General disorders
Fatigue
|
0.19%
1/514 • Number of events 1
|
0.20%
1/500 • Number of events 1
|
0.00%
0/486
|
|
General disorders
Fever
|
0.19%
1/514 • Number of events 1
|
0.40%
2/500 • Number of events 2
|
0.62%
3/486 • Number of events 3
|
|
General disorders
Head, Eyes, Ears, Nose, Throat (HEENT)
|
0.78%
4/514 • Number of events 4
|
0.60%
3/500 • Number of events 3
|
1.2%
6/486 • Number of events 6
|
|
General disorders
Multi-System Failure
|
0.19%
1/514 • Number of events 1
|
0.20%
1/500 • Number of events 1
|
0.62%
3/486 • Number of events 3
|
|
General disorders
Related to Multiple Symptoms
|
0.97%
5/514 • Number of events 5
|
0.00%
0/500
|
0.41%
2/486 • Number of events 2
|
|
General disorders
Non-Cardiovascular, Patient Condition
|
0.39%
2/514 • Number of events 2
|
1.2%
6/500 • Number of events 8
|
1.0%
5/486 • Number of events 5
|
|
General disorders
Physical Trauma
|
1.4%
7/514 • Number of events 7
|
1.0%
5/500 • Number of events 5
|
1.6%
8/486 • Number of events 8
|
|
General disorders
Psychological
|
0.58%
3/514 • Number of events 3
|
0.20%
1/500 • Number of events 1
|
0.00%
0/486
|
|
General disorders
Cancer
|
1.2%
6/514 • Number of events 6
|
1.0%
5/500 • Number of events 5
|
1.4%
7/486 • Number of events 8
|
|
General disorders
Syncope, General
|
0.58%
3/514 • Number of events 3
|
0.80%
4/500 • Number of events 4
|
0.41%
2/486 • Number of events 2
|
|
Immune system disorders
Immune
|
0.39%
2/514 • Number of events 2
|
0.00%
0/500
|
0.00%
0/486
|
|
Infections and infestations
Systemic Infection
|
0.58%
3/514 • Number of events 3
|
1.2%
6/500 • Number of events 6
|
1.4%
7/486 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
2.9%
15/514 • Number of events 16
|
3.4%
17/500 • Number of events 17
|
2.1%
10/486 • Number of events 12
|
|
Nervous system disorders
Neurological
|
1.6%
8/514 • Number of events 9
|
0.60%
3/500 • Number of events 3
|
1.0%
5/486 • Number of events 7
|
|
Nervous system disorders
Syncope, Neurological Related
|
0.39%
2/514 • Number of events 2
|
0.20%
1/500 • Number of events 1
|
0.21%
1/486 • Number of events 2
|
|
Renal and urinary disorders
Genitourinary
|
1.9%
10/514 • Number of events 12
|
1.4%
7/500 • Number of events 7
|
0.41%
2/486 • Number of events 3
|
|
Renal and urinary disorders
Renal
|
2.7%
14/514 • Number of events 14
|
1.0%
5/500 • Number of events 5
|
1.4%
7/486 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.4%
7/514 • Number of events 10
|
1.4%
7/500 • Number of events 7
|
0.62%
3/486 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
3.5%
18/514 • Number of events 22
|
4.0%
20/500 • Number of events 22
|
3.3%
16/486 • Number of events 16
|
|
Skin and subcutaneous tissue disorders
Integumentary
|
0.39%
2/514 • Number of events 4
|
0.60%
3/500 • Number of events 4
|
0.62%
3/486 • Number of events 3
|
|
Surgical and medical procedures
Myocardial Perforation, Post-Implant, Right Ventricular
|
0.00%
0/514
|
0.00%
0/500
|
0.21%
1/486 • Number of events 1
|
|
Surgical and medical procedures
Seroma, Pocket (<= 30 days Post Pulse Generator Implant)
|
0.00%
0/514
|
0.20%
1/500 • Number of events 1
|
0.00%
0/486
|
|
Surgical and medical procedures
Adverse Reaction, Implant Procedure Related
|
0.39%
2/514 • Number of events 3
|
0.80%
4/500 • Number of events 5
|
0.00%
0/486
|
|
Surgical and medical procedures
Bleeding, Implant Procedure Related
|
0.97%
5/514 • Number of events 5
|
0.40%
2/500 • Number of events 2
|
0.41%
2/486 • Number of events 2
|
|
Surgical and medical procedures
Coronary Venous Trauma
|
0.00%
0/514
|
0.00%
0/500
|
0.21%
1/486 • Number of events 1
|
|
Surgical and medical procedures
Hematoma, Pulse Generator Pocket (>30 days Post Device Implant)
|
0.19%
1/514 • Number of events 1
|
0.00%
0/500
|
0.00%
0/486
|
|
Surgical and medical procedures
Infection, (> 30 days Post Device Implant)
|
1.2%
6/514 • Number of events 6
|
1.0%
5/500 • Number of events 5
|
0.82%
4/486 • Number of events 4
|
|
Surgical and medical procedures
Pneumothorax, Procedure Related
|
0.97%
5/514 • Number of events 5
|
1.0%
5/500 • Number of events 5
|
0.21%
1/486 • Number of events 1
|
|
Surgical and medical procedures
Post Surgical Wound Discomfort
|
0.19%
1/514 • Number of events 1
|
0.20%
1/500 • Number of events 1
|
0.21%
1/486 • Number of events 1
|
|
Surgical and medical procedures
Post Surgical Infection (<= 30 days Post Device Implant)
|
0.58%
3/514 • Number of events 3
|
0.80%
4/500 • Number of events 4
|
0.62%
3/486 • Number of events 3
|
|
Surgical and medical procedures
Post Surgical Pocket Hemorrhage
|
0.19%
1/514 • Number of events 1
|
0.00%
0/500
|
0.00%
0/486
|
|
Surgical and medical procedures
Venous Occlusion
|
0.19%
1/514 • Number of events 1
|
0.00%
0/500
|
0.21%
1/486 • Number of events 1
|
|
Vascular disorders
Vascular Related
|
1.4%
7/514 • Number of events 10
|
0.80%
4/500 • Number of events 4
|
2.1%
10/486 • Number of events 11
|
Other adverse events
| Measure |
A - Standard ICD Programming
n=514 participants at risk
Standard ICD Programming
Standard ICD programming : Standard ICD programming
|
B - High Rate Cutoff
n=500 participants at risk
High rate cutoff
High rate cutoff : Programming of a high rate cutoff
|
C - Long ICD Duration Delay
n=486 participants at risk
Long ICD duration delay
Long delay : Programming of a prolonged delay
|
|---|---|---|---|
|
Cardiac disorders
Extracardiac Stimulation, Left Ventricular
|
6.2%
32/514 • Number of events 38
|
5.2%
26/500 • Number of events 28
|
4.9%
24/486 • Number of events 25
|
|
Cardiac disorders
Heart Failure Symptoms
|
6.6%
34/514 • Number of events 44
|
6.4%
32/500 • Number of events 37
|
7.2%
35/486 • Number of events 39
|
|
Cardiac disorders
Inappropriate Tachy Therapy
|
16.5%
85/514 • Number of events 103
|
0.00%
0/500
|
4.1%
20/486 • Number of events 24
|
|
Cardiac disorders
Pacemaker-mediated Tachycardia (PMT)
|
0.00%
0/514
|
5.8%
29/500 • Number of events 30
|
4.1%
20/486 • Number of events 22
|
|
Cardiac disorders
Supraventricular Tachy Arrhythmia
|
5.8%
30/514 • Number of events 34
|
5.8%
29/500 • Number of events 30
|
4.5%
22/486 • Number of events 25
|
|
Cardiac disorders
Ventricular Tachyarrhythmia
|
5.1%
26/514 • Number of events 32
|
4.0%
20/500 • Number of events 22
|
0.00%
0/486
|
Additional Information
Dr. Arthur J. Moss
University of Rochester, Heart Research Follow-up Program
Phone: 585-275-5391
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60