Trial Outcomes & Findings for OMNI Study--Assessing Therapies in Medtronic Pacemaker, Defibrillator, and Cardiac Resynchronization Therapy Devices. (NCT NCT00277524)
NCT ID: NCT00277524
Last Updated: 2013-08-28
Results Overview
Frequencies of implanted systems were measured among patients who were implanted with a device (IPT, ICD or CRT-D).
TERMINATED
3032 participants
Baseline
2013-08-28
Participant Flow
The study included 147 outpatient cardiology practices in the United States. Inclusion criteria were(1) implant of an implantable pulse generator (IPG), implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D); and (2) age 18 years or older. Enrollment period was from Aug 2005 to Jun 2006.
This is a post-market prospective study. No group assignment is given. Subjects implanted with IPGs were enrolled and followed at 6 and 12 months. Subjects implanted with ICDs or CRT-Ds were enrolled and followed at six, 12, 24, 36, 48, and 60 months.
Participant milestones
| Measure |
Subjects With IPG
Subjects implanted with an implantable pulse generator (IPG).
|
Subjects With Single Chamber ICD
Subjects implanted with a single chamber implantable cardioverter defibrillator (ICD).
|
Subjects With Dual Chamber ICD
Subjects implanted with a dual chamber implantable cardioverter defibrillator (ICD).
|
Subjects With CRT-D
Subjects implanted with a cardiac resynchronization therapy defibrillator (CRT-D).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
621
|
324
|
1088
|
850
|
|
Overall Study
COMPLETED
|
621
|
324
|
1088
|
850
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
OMNI Study--Assessing Therapies in Medtronic Pacemaker, Defibrillator, and Cardiac Resynchronization Therapy Devices.
Baseline characteristics by cohort
| Measure |
Overall
n=2883 Participants
All patients enrolled in OMNI.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
988 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1895 Participants
n=5 Participants
|
|
Age Continuous
|
68.7 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
907 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1976 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
38 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
335 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
206 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian
|
8 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
2217 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2883 participants
n=5 Participants
|
|
Weight
|
188 lbs
STANDARD_DEVIATION 45.3 • n=5 Participants
|
|
QRS duration
|
119.9 ms
STANDARD_DEVIATION 34.0 • n=5 Participants
|
|
PR interval
|
182.6 ms
STANDARD_DEVIATION 45.5 • n=5 Participants
|
|
LVEF(%)
|
33.4 participants
STANDARD_DEVIATION 15.7 • n=5 Participants
|
|
New York Heart Association (NYHA) classification
I
|
104 participants
n=5 Participants
|
|
New York Heart Association (NYHA) classification
II
|
627 participants
n=5 Participants
|
|
New York Heart Association (NYHA) classification
III
|
857 participants
n=5 Participants
|
|
New York Heart Association (NYHA) classification
IV
|
72 participants
n=5 Participants
|
|
New York Heart Association (NYHA) classification
No Heart Failure
|
600 participants
n=5 Participants
|
|
New York Heart Association (NYHA) classification
Missing
|
5 participants
n=5 Participants
|
|
Heart failure (HF) stage
A
|
44 participants
n=5 Participants
|
|
Heart failure (HF) stage
B
|
229 participants
n=5 Participants
|
|
Heart failure (HF) stage
C
|
713 participants
n=5 Participants
|
|
Heart failure (HF) stage
D
|
44 participants
n=5 Participants
|
|
Heart failure (HF) stage
No HF
|
578 participants
n=5 Participants
|
|
Heart failure (HF) stage
NA
|
1275 participants
n=5 Participants
|
|
Number of patients implanted
|
2882 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselineFrequencies of implanted systems were measured among patients who were implanted with a device (IPT, ICD or CRT-D).
Outcome measures
| Measure |
Implanted Subjects
n=2882 Participants
All patients enrolled in OMNI.
|
ICD (N=1029)
ICD Patients with MVP enabled and follow up data available
|
36-month Follow-up
Total subjects with disease progressed at 36 months
|
48-month Follow-up
Total subjects with disease progressed at 48 months
|
|---|---|---|---|---|
|
Implanted Systems Frequencies
EnRhythm (P1501DR)
|
620 participants
|
—
|
—
|
—
|
|
Implanted Systems Frequencies
EnTrust AT (D154ATG)
|
820 participants
|
—
|
—
|
—
|
|
Implanted Systems Frequencies
EnTrust VR (D154VRC)
|
321 participants
|
—
|
—
|
—
|
|
Implanted Systems Frequencies
InSync Sentry (7297)
|
30 participants
|
—
|
—
|
—
|
|
Implanted Systems Frequencies
InSync Sentry (7299)
|
820 participants
|
—
|
—
|
—
|
|
Implanted Systems Frequencies
Intrinsic DR (7288)
|
271 participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: BaselinePacing mode is based on the NASPE/BPEG Generic (NBG) Pacemake coding which includes: I, the chambers paced (V= Ventricle, A=Atrium, D=Dual (A\&V), O=None); II, the chambers sensed (V= Ventricle, A=Atrium, D=Dual (A\&V), O=None); III, the mode of response (T=Triggered, I=Inhibited, D=Dual Triggered/Inhibited, O=None); IV, the programmable functions(R=Rate Modulated, C=Communicating, M=Multiprogrammable, P=Simple Programmable, O=None); V, the antitachycardia functions (O=None, P=Paced, S=Shocks, D=Dual (P\&S)). In addition, MVP (managed ventricular pacing) is a mode that promotes AV conduction by reducing or eliminating unnecessary RV pacing but maintains dual chamber ventricular support in the event that AV conduction is lost.
Outcome measures
| Measure |
Implanted Subjects
n=620 Participants
All patients enrolled in OMNI.
|
ICD (N=1029)
ICD Patients with MVP enabled and follow up data available
|
36-month Follow-up
Total subjects with disease progressed at 36 months
|
48-month Follow-up
Total subjects with disease progressed at 48 months
|
|---|---|---|---|---|
|
Implantable Pulse Generator (IPG) Device Baseline Programming Frequencies.
Pacing Mode, DDD/DDDR
|
81 participants
|
—
|
—
|
—
|
|
Implantable Pulse Generator (IPG) Device Baseline Programming Frequencies.
Pacing Mode, DDI/DDIR
|
4 participants
|
—
|
—
|
—
|
|
Implantable Pulse Generator (IPG) Device Baseline Programming Frequencies.
Pacing Mode, MVP_AAIR_DD
|
380 participants
|
—
|
—
|
—
|
|
Implantable Pulse Generator (IPG) Device Baseline Programming Frequencies.
Pacing Mode, MVP_AAI_DDD
|
148 participants
|
—
|
—
|
—
|
|
Implantable Pulse Generator (IPG) Device Baseline Programming Frequencies.
Pacing Mode, VVI/VVIR
|
7 participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: BaselineICD/CRT-D baseline programming, pacing mode and detection. Pacing mode is based on the NASPE/BPEG Generic (NBG) Pacemake coding which includes: I, the chambers paced (V= Ventricle, A=Atrium, D=Dual (A\&V), O=None); II, the chambers sensed (V= Ventricle, A=Atrium, D=Dual (A\&V), O=None); III, the mode of response (T=Triggered, I=Inhibited, D=Dual Triggered/Inhibited, O=None); IV, the programmable functions(R=Rate Modulated, C=Communicating, M=Multiprogrammable, P=Simple Programmable, O=None); V, the antitachycardia functions (O=None, P=Paced, S=Shocks, D=Dual (P\&S)). In addition, MVP (managed ventricular pacing) is a mode that promotes AV conduction by reducing or eliminating unnecessary RV pacing but maintains dual chamber ventricular support in the event that AV conduction is lost.
Outcome measures
| Measure |
Implanted Subjects
n=2262 ICD/CRT-D Devices
All patients enrolled in OMNI.
|
ICD (N=1029)
ICD Patients with MVP enabled and follow up data available
|
36-month Follow-up
Total subjects with disease progressed at 36 months
|
48-month Follow-up
Total subjects with disease progressed at 48 months
|
|---|---|---|---|---|
|
ICD/CRT-D Device Baseline Programming Frequencies
Pacing Mode, DDD/DDDR
|
804 participants
|
—
|
—
|
—
|
|
ICD/CRT-D Device Baseline Programming Frequencies
Pacing Mode, DDI/DDIR
|
21 participants
|
—
|
—
|
—
|
|
ICD/CRT-D Device Baseline Programming Frequencies
Pacing Mode, MVP_AAIR_DD
|
525 participants
|
—
|
—
|
—
|
|
ICD/CRT-D Device Baseline Programming Frequencies
Pacing Mode, MVP_AAI_DDD
|
481 participants
|
—
|
—
|
—
|
|
ICD/CRT-D Device Baseline Programming Frequencies
Pacing Mode, VVI/VVIR
|
424 participants
|
—
|
—
|
—
|
|
ICD/CRT-D Device Baseline Programming Frequencies
ATP Status, Before Charging
|
23 participants
|
—
|
—
|
—
|
|
ICD/CRT-D Device Baseline Programming Frequencies
ATP Status, During Charging
|
1089 participants
|
—
|
—
|
—
|
|
ICD/CRT-D Device Baseline Programming Frequencies
ATP Status, Off
|
26 participants
|
—
|
—
|
—
|
|
ICD/CRT-D Device Baseline Programming Frequencies
VF Detection Enable, On
|
2234 participants
|
—
|
—
|
—
|
|
ICD/CRT-D Device Baseline Programming Frequencies
VT Detection Enable, On
|
1283 participants
|
—
|
—
|
—
|
|
ICD/CRT-D Device Baseline Programming Frequencies
VT Detection Enable, Monitor
|
345 participants
|
—
|
—
|
—
|
|
ICD/CRT-D Device Baseline Programming Frequencies
VF Initial NID, 12/16
|
1176 participants
|
—
|
—
|
—
|
|
ICD/CRT-D Device Baseline Programming Frequencies
VF Initial NID, 18/24
|
1077 participants
|
—
|
—
|
—
|
|
ICD/CRT-D Device Baseline Programming Frequencies
VF Initial NID, 24/32
|
2 participants
|
—
|
—
|
—
|
|
ICD/CRT-D Device Baseline Programming Frequencies
FVT Detection On via VF zone
|
829 participants
|
—
|
—
|
—
|
|
ICD/CRT-D Device Baseline Programming Frequencies
FVT Detection On via VT zone
|
27 participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: BaselineICD/CRT-D baseline programming measurements, detection interval. Implanted Cardioverter/Defibrillator paces a patient's heart in a tachyarrhythmia prevention-pacing mode. Detection intervals are used to detect atrial tachyarrhythmia. Detection Intervals are programmable heart rate thresholds. R-R intervals that are less than the VT or VF detection intervals (in ms) are considered evidence of VT or VF, respectively. R-R intervals that are between the FVT and the VF detection intervals are considered evidence of FVT. Thus, these detection interval thresholds demarcate rate zones of detection. The rate zones are used to determine the type of therapy applied once detection occurs.
Outcome measures
| Measure |
Implanted Subjects
n=2262 Participants
All patients enrolled in OMNI.
|
ICD (N=1029)
ICD Patients with MVP enabled and follow up data available
|
36-month Follow-up
Total subjects with disease progressed at 36 months
|
48-month Follow-up
Total subjects with disease progressed at 48 months
|
|---|---|---|---|---|
|
ICD/CRT-D Device Baseline Programming Measurements
Pace AV
|
168 ms
Standard Deviation 39.2
|
—
|
—
|
—
|
|
ICD/CRT-D Device Baseline Programming Measurements
Sense AV
|
139 ms
Standard Deviation 40.8
|
—
|
—
|
—
|
|
ICD/CRT-D Device Baseline Programming Measurements
FVT Detection Interval
|
260 ms
Standard Deviation 24.6
|
—
|
—
|
—
|
|
ICD/CRT-D Device Baseline Programming Measurements
VF Detection Interval
|
314 ms
Standard Deviation 17.1
|
—
|
—
|
—
|
|
ICD/CRT-D Device Baseline Programming Measurements
VT Detection Interval
|
383 ms
Standard Deviation 25.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 months post enrollmentFrequencies of subject with AV block over time between ICD and Implantable Pulse Generator(IPG) study participants.
Outcome measures
| Measure |
Implanted Subjects
n=610 Participants
All patients enrolled in OMNI.
|
ICD (N=1029)
n=1029 Participants
ICD Patients with MVP enabled and follow up data available
|
36-month Follow-up
Total subjects with disease progressed at 36 months
|
48-month Follow-up
Total subjects with disease progressed at 48 months
|
|---|---|---|---|---|
|
AV Block Status by Device Type at 6 and 12 Months.
6 Months: Subjects with MVP enabled, N
|
441 participants
12.5
|
815 participants
|
—
|
—
|
|
AV Block Status by Device Type at 6 and 12 Months.
6 Months: AV Block 1st degree
|
103 participants
|
167 participants
|
—
|
—
|
|
AV Block Status by Device Type at 6 and 12 Months.
6 Months: AV Block 2nd degree Type I
|
11 participants
|
7 participants
|
—
|
—
|
|
AV Block Status by Device Type at 6 and 12 Months.
6 Months: AV Block 2nd degree Type II
|
19 participants
|
7 participants
|
—
|
—
|
|
AV Block Status by Device Type at 6 and 12 Months.
6 Months: AV Block 3rd degree Intermittent
|
39 participants
|
5 participants
|
—
|
—
|
|
AV Block Status by Device Type at 6 and 12 Months.
6 Months: AV Block 3rd degree Persistent
|
11 participants
|
5 participants
|
—
|
—
|
|
AV Block Status by Device Type at 6 and 12 Months.
6 Months: None
|
250 participants
|
603 participants
|
—
|
—
|
|
AV Block Status by Device Type at 6 and 12 Months.
12 Months: Subjects with MVP enabled, N
|
389 participants
|
732 participants
|
—
|
—
|
|
AV Block Status by Device Type at 6 and 12 Months.
12 Months: AV Block 1st degree
|
90 participants
|
159 participants
|
—
|
—
|
|
AV Block Status by Device Type at 6 and 12 Months.
12 Months: AV Block 2nd degree Type I
|
12 participants
|
7 participants
|
—
|
—
|
|
AV Block Status by Device Type at 6 and 12 Months.
12 Months: AV Block 2nd degree Type II
|
7 participants
|
7 participants
|
—
|
—
|
|
AV Block Status by Device Type at 6 and 12 Months.
12 Months: AV Block 3rd degree Intermittent
|
30 participants
|
5 participants
|
—
|
—
|
|
AV Block Status by Device Type at 6 and 12 Months.
12 Months: AV Block 3rd degree Persistent
|
14 participants
|
7 participants
|
—
|
—
|
|
AV Block Status by Device Type at 6 and 12 Months.
12 Months: None
|
216 participants
|
523 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 years post implantFrequencies of Subjects with AV Block Over Time by Severity of Historical AV Block
Outcome measures
| Measure |
Implanted Subjects
n=1098 Participants
All patients enrolled in OMNI.
|
ICD (N=1029)
n=541 Participants
ICD Patients with MVP enabled and follow up data available
|
36-month Follow-up
Total subjects with disease progressed at 36 months
|
48-month Follow-up
Total subjects with disease progressed at 48 months
|
|---|---|---|---|---|
|
AV Block Status by Severity of Historical AV Block
48 Months: AV Block 3rd degree Intermittent
|
0 participants
|
2 participants
|
—
|
—
|
|
AV Block Status by Severity of Historical AV Block
6 Months: Subjects with MVP enabled
|
883 participants
|
373 participants
|
—
|
—
|
|
AV Block Status by Severity of Historical AV Block
6 Months: AV Block 1st degree
|
49 participants
|
221 participants
|
—
|
—
|
|
AV Block Status by Severity of Historical AV Block
6 Months: AV Block 2nd degree Type I
|
1 participants
|
17 participants
|
—
|
—
|
|
AV Block Status by Severity of Historical AV Block
6 Months: AV Block 2nd degree Type II
|
1 participants
|
25 participants
|
—
|
—
|
|
AV Block Status by Severity of Historical AV Block
6 Months: AV Block 3rd degree Intermittent
|
2 participants
|
42 participants
|
—
|
—
|
|
AV Block Status by Severity of Historical AV Block
6 Months: AV Block 3rd degree Persistent
|
3 participants
|
13 participants
|
—
|
—
|
|
AV Block Status by Severity of Historical AV Block
6 Months: None
|
818 participants
|
35 participants
|
—
|
—
|
|
AV Block Status by Severity of Historical AV Block
12 Months: Subjects with MVP enabled
|
786 participants
|
335 participants
|
—
|
—
|
|
AV Block Status by Severity of Historical AV Block
12 Months: AV Block 1st degree
|
73 participants
|
176 participants
|
—
|
—
|
|
AV Block Status by Severity of Historical AV Block
12 Months: AV Block 2nd degree Type I
|
0 participants
|
19 participants
|
—
|
—
|
|
AV Block Status by Severity of Historical AV Block
12 Months: AV Block 2nd degree Type II
|
1 participants
|
13 participants
|
—
|
—
|
|
AV Block Status by Severity of Historical AV Block
12 Months: AV Block 3rd degree Intermittent
|
5 participants
|
30 participants
|
—
|
—
|
|
AV Block Status by Severity of Historical AV Block
12 Months: AV Block 3rd degree Persistent
|
3 participants
|
18 participants
|
—
|
—
|
|
AV Block Status by Severity of Historical AV Block
12 Months: None
|
689 participants
|
50 participants
|
—
|
—
|
|
AV Block Status by Severity of Historical AV Block
24 Months: Subjects with MVP enabled
|
426 participants
|
146 participants
|
—
|
—
|
|
AV Block Status by Severity of Historical AV Block
24 Months: AV Block 1st degree
|
51 participants
|
95 participants
|
—
|
—
|
|
AV Block Status by Severity of Historical AV Block
24 Months: AV Block 2nd degree Type I
|
0 participants
|
5 participants
|
—
|
—
|
|
AV Block Status by Severity of Historical AV Block
24 Months: AV Block 2nd degree Type II
|
0 participants
|
3 participants
|
—
|
—
|
|
AV Block Status by Severity of Historical AV Block
24 Months: AV Block 3rd degree Intermittent
|
1 participants
|
3 participants
|
—
|
—
|
|
AV Block Status by Severity of Historical AV Block
24 Months: AV Block 3rd degree Persistent
|
0 participants
|
2 participants
|
—
|
—
|
|
AV Block Status by Severity of Historical AV Block
24 Months: None
|
362 participants
|
24 participants
|
—
|
—
|
|
AV Block Status by Severity of Historical AV Block
36 Months: Subjects with MVP enabled
|
324 participants
|
105 participants
|
—
|
—
|
|
AV Block Status by Severity of Historical AV Block
36 Months: AV Block 1st degree
|
58 participants
|
69 participants
|
—
|
—
|
|
AV Block Status by Severity of Historical AV Block
36 Months: AV Block 2nd degree Type I
|
1 participants
|
3 participants
|
—
|
—
|
|
AV Block Status by Severity of Historical AV Block
36 Months: AV Block 2nd degree Type II
|
0 participants
|
2 participants
|
—
|
—
|
|
AV Block Status by Severity of Historical AV Block
36 Months: AV Block 3rd degree Intermittent
|
0 participants
|
3 participants
|
—
|
—
|
|
AV Block Status by Severity of Historical AV Block
36 Months: AV Block 3rd degree Persistent
|
0 participants
|
2 participants
|
—
|
—
|
|
AV Block Status by Severity of Historical AV Block
36 Months: None
|
253 participants
|
18 participants
|
—
|
—
|
|
AV Block Status by Severity of Historical AV Block
48 Months: Subjects with MVP enabled
|
269 participants
|
92 participants
|
—
|
—
|
|
AV Block Status by Severity of Historical AV Block
48 Months: AV Block 1st degree
|
59 participants
|
59 participants
|
—
|
—
|
|
AV Block Status by Severity of Historical AV Block
48 Months: AV Block 2nd degree Type I
|
0 participants
|
2 participants
|
—
|
—
|
|
AV Block Status by Severity of Historical AV Block
48 Months: AV Block 2nd degree Type II
|
0 participants
|
1 participants
|
—
|
—
|
|
AV Block Status by Severity of Historical AV Block
48 Months: AV Block 3rd degree Persistent
|
1 participants
|
2 participants
|
—
|
—
|
|
AV Block Status by Severity of Historical AV Block
48 Months: None
|
201 participants
|
17 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 years post enrollmentEvaluate the utility of the Antitachycardia Pacing (ATP) During Charging feature of the device.
Outcome measures
| Measure |
Implanted Subjects
n=343 Participants
All patients enrolled in OMNI.
|
ICD (N=1029)
ICD Patients with MVP enabled and follow up data available
|
36-month Follow-up
Total subjects with disease progressed at 36 months
|
48-month Follow-up
Total subjects with disease progressed at 48 months
|
|---|---|---|---|---|
|
Summary of ATP Episodes Within All Treated Episodes
Number of episodes analyzed from 343 participants
|
1584 Episodes
|
—
|
—
|
—
|
|
Summary of ATP Episodes Within All Treated Episodes
Episodes with ATP attempted
|
1100 Episodes
|
—
|
—
|
—
|
|
Summary of ATP Episodes Within All Treated Episodes
Episodes with Sucessful ATP
|
650 Episodes
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 years post implantFirst shock rate for VF and FVT zones was estimated using Kaplan-Meier method. OMNI "PainFREE" definition: programming combinations that result in ATP therapy for ventricular tachycardia (VT) at cycle lengths \<320 ms. Programming at cycle lengths ≥320 ms were not mandated. OMNI "SCD-HeFT" definition: programming combinations that result in shock therapy only for arrhythmias at cycle lengths of \<320 ms or faster and no therapy for arrhythmias at cycle lengths ≥320 ms.
Outcome measures
| Measure |
Implanted Subjects
n=1116 Participants
All patients enrolled in OMNI.
|
ICD (N=1029)
n=462 Participants
ICD Patients with MVP enabled and follow up data available
|
36-month Follow-up
Total subjects with disease progressed at 36 months
|
48-month Follow-up
Total subjects with disease progressed at 48 months
|
|---|---|---|---|---|
|
Compare First Shock Rate Between Medtronic "PainFREE" Programming and "SCD-HeFT" Programming in Primary Prevention Study Participants.
At implant
|
0 rate
Standard Deviation 0
|
0 rate
Standard Deviation 0
|
—
|
—
|
|
Compare First Shock Rate Between Medtronic "PainFREE" Programming and "SCD-HeFT" Programming in Primary Prevention Study Participants.
12 months after implant
|
0.10 rate
Standard Deviation 0.009
|
0.15 rate
Standard Deviation 0.017
|
—
|
—
|
|
Compare First Shock Rate Between Medtronic "PainFREE" Programming and "SCD-HeFT" Programming in Primary Prevention Study Participants.
24 months after implant
|
0.14 rate
Standard Deviation 0.011
|
0.21 rate
Standard Deviation 0.019
|
—
|
—
|
|
Compare First Shock Rate Between Medtronic "PainFREE" Programming and "SCD-HeFT" Programming in Primary Prevention Study Participants.
36 months after implant
|
0.18 rate
Standard Deviation 0.013
|
0.24 rate
Standard Deviation 0.021
|
—
|
—
|
|
Compare First Shock Rate Between Medtronic "PainFREE" Programming and "SCD-HeFT" Programming in Primary Prevention Study Participants.
48 months after implant
|
0.20 rate
Standard Deviation 0.014
|
0.27 rate
Standard Deviation 0.023
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 years post implantEstimate the correlation between OptiVol trends and disease progression. A subject's disease status was said to have progressed if: 1. The NYHA classification number increases (example: I to II), or 2. The LVEF decreases by at least 20% (relative difference) and by at least a 5% absolute difference, or 3. The subject expires A subject who crossed OptiVol threshold since last visit was regarded as 'crossed threshold'.
Outcome measures
| Measure |
Implanted Subjects
n=488 Participants
All patients enrolled in OMNI.
|
ICD (N=1029)
n=375 Participants
ICD Patients with MVP enabled and follow up data available
|
36-month Follow-up
n=326 Participants
Total subjects with disease progressed at 36 months
|
48-month Follow-up
n=257 Participants
Total subjects with disease progressed at 48 months
|
|---|---|---|---|---|
|
Frequencies of Subjects With OptiVol Trends and Disease Progression.
Disease Progressed, N
|
97 participants
|
95 participants
|
93 participants
|
84 participants
|
|
Frequencies of Subjects With OptiVol Trends and Disease Progression.
Crossed Threshold, N
|
382 participants
|
327 participants
|
287 participants
|
224 participants
|
Adverse Events
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Melinda Hoey, Clinical Research Specialist
Medtronic Cardiac Rhythm Disease Management
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place