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Trial record 95 of 132 for:    "Paroxysmal Ventricular Fibrillation"

OMNI Study--Assessing Therapies in Medtronic Pacemaker, Defibrillator, and Cardiac Resynchronization Therapy Devices. (OMNI)

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ClinicalTrials.gov Identifier: NCT00277524
Recruitment Status : Terminated (Ended follow-up after four years)
First Posted : January 16, 2006
Results First Posted : August 28, 2013
Last Update Posted : August 28, 2013
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Study Type Observational
Study Design Time Perspective: Prospective
Conditions Tachycardia, Ventricular
Heart Failure, Congestive
Ventricular Fibrillation
Ventricular Dysfunction
Bradycardia
Enrollment 3032
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Subjects With IPG Subjects With Single Chamber ICD Subjects With Dual Chamber ICD Subjects With CRT-D
Hide Arm/Group Description Subjects implanted with an implantable pulse generator (IPG). Subjects implanted with a single chamber implantable cardioverter defibrillator (ICD). Subjects implanted with a dual chamber implantable cardioverter defibrillator (ICD). Subjects implanted with a cardiac resynchronization therapy defibrillator (CRT-D).
Period Title: Overall Study
Started 621 324 1088 850
Completed 621 324 1088 850
Not Completed 0 0 0 0
Arm/Group Title Overall
Hide Arm/Group Description All patients enrolled in OMNI.
Overall Number of Baseline Participants 2883
Hide Baseline Analysis Population Description
Subjects implanted with an IPG, ICD or CRT-D and age 18 years or older were eligible for the OMNI study. Clinical data and device programming at baseline from all subjects was summarized for categorical and continuous variables using descriptive statistics.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2883 participants
<=18 years
0
   0.0%
Between 18 and 65 years
988
  34.3%
>=65 years
1895
  65.7%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2883 participants
68.7  (12.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2883 participants
Female
907
  31.5%
Male
1976
  68.5%
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2883 participants
American Indian 7
Asian 38
Black 335
Hispanic 206
Native Hawaiian 8
White 2217
Other 6
[1]
Measure Description: 2817 subjects had information on race or ethnic origin.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2883 participants
2883
Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Lbs
Number Analyzed 2883 participants
188  (45.3)
[1]
Measure Description: 2781 subjects had information on weight.
QRS duration   [1] 
Mean (Standard Deviation)
Unit of measure:  Ms
Number Analyzed 2883 participants
119.9  (34.0)
[1]
Measure Description: 2132 subjects had information on QRS duration.
PR interval   [1] 
Mean (Standard Deviation)
Unit of measure:  Ms
Number Analyzed 2883 participants
182.6  (45.5)
[1]
Measure Description: 1829 subjects had information on PR interval.
LVEF(%)   [1] 
Mean (Standard Deviation)
Unit of measure:  Participants
Number Analyzed 2883 participants
33.4  (15.7)
[1]
Measure Description: 2487 subjects had information on left ventricular ejection fraction (LVEF, %).
New York Heart Association (NYHA) classification   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2883 participants
I 104
II 627
III 857
IV 72
No Heart Failure 600
Missing 5
[1]
Measure Description: New York Heart Association (NYHA) classification is used to classify the extent of heart failure. It has four classes: Class I (Mild), Class II (Mild), Class III (Moderate), and Class IV (Severe).
Heart failure (HF) stage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2883 participants
A 44
B 229
C 713
D 44
No HF 578
NA 1275
[1]
Measure Description:

This is a new classification heart failure (HF) which include four stages:

Stage A - At high risk for HF but without structural heart disease or symptoms of HF; Stage B - Structural heart disease but without signs or symptoms of HF; Stage C - Structural heart disease with prior or current symptoms of HF; Stage D - Refractory HF requiring specialized interventions.

Number of patients implanted  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2883 participants
2882
1.Primary Outcome
Title Implanted Systems Frequencies
Hide Description Frequencies of implanted systems were measured among patients who were implanted with a device (IPT, ICD or CRT-D).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Implanted Subjects
Hide Arm/Group Description:
All patients enrolled in OMNI.
Overall Number of Participants Analyzed 2882
Measure Type: Number
Unit of Measure: participants
EnRhythm (P1501DR) 620
EnTrust AT (D154ATG) 820
EnTrust VR (D154VRC) 321
InSync Sentry (7297) 30
InSync Sentry (7299) 820
Intrinsic DR (7288) 271
2.Primary Outcome
Title Implantable Pulse Generator (IPG) Device Baseline Programming Frequencies.
Hide Description 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.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IPG Group
Hide Arm/Group Description:
Subjects implanted with IPG
Overall Number of Participants Analyzed 620
Measure Type: Number
Unit of Measure: participants
Pacing Mode, DDD/DDDR 81
Pacing Mode, DDI/DDIR 4
Pacing Mode, MVP_AAIR_DD 380
Pacing Mode, MVP_AAI_DDD 148
Pacing Mode, VVI/VVIR 7
3.Primary Outcome
Title ICD/CRT-D Device Baseline Programming Frequencies
Hide Description ICD/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.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ICD/CRT-D Group
Hide Arm/Group Description:
Subjects implanted with ICD/CRT-D
Overall Number of Participants Analyzed 2262
Overall Number of Units Analyzed
Type of Units Analyzed: ICD/CRT-D Devices
2262
Measure Type: Number
Unit of Measure: participants
Pacing Mode, DDD/DDDR 804
Pacing Mode, DDI/DDIR 21
Pacing Mode, MVP_AAIR_DD 525
Pacing Mode, MVP_AAI_DDD 481
Pacing Mode, VVI/VVIR 424
ATP Status, Before Charging 23
ATP Status, During Charging 1089
ATP Status, Off 26
VF Detection Enable, On 2234
VT Detection Enable, On 1283
VT Detection Enable, Monitor 345
VF Initial NID, 12/16 1176
VF Initial NID, 18/24 1077
VF Initial NID, 24/32 2
FVT Detection On via VF zone 829
FVT Detection On via VT zone 27
4.Primary Outcome
Title ICD/CRT-D Device Baseline Programming Measurements
Hide Description

ICD/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.

Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ICD/CRT-D Group
Hide Arm/Group Description:
Subjects implanted with Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy-Defibrillator (ICD/CRT-D).
Overall Number of Participants Analyzed 2262
Mean (Standard Deviation)
Unit of Measure: ms
Pace AV 168  (39.2)
Sense AV 139  (40.8)
FVT Detection Interval 260  (24.6)
VF Detection Interval 314  (17.1)
VT Detection Interval 383  (25.2)
5.Secondary Outcome
Title AV Block Status by Device Type at 6 and 12 Months.
Hide Description Frequencies of subject with AV block over time between ICD and Implantable Pulse Generator(IPG) study participants.
Time Frame 12 months post enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IPG (N=610) ICD (N=1029)
Hide Arm/Group Description:
IPG Patients with MVP enabled and follow up data available
ICD Patients with MVP enabled and follow up data available
Overall Number of Participants Analyzed 610 1029
Measure Type: Number
Unit of Measure: participants
6 Months: Subjects with MVP enabled, N 441 815
6 Months: AV Block 1st degree 103 167
6 Months: AV Block 2nd degree Type I 11 7
6 Months: AV Block 2nd degree Type II 19 7
6 Months: AV Block 3rd degree Intermittent 39 5
6 Months: AV Block 3rd degree Persistent 11 5
6 Months: None 250 603
12 Months: Subjects with MVP enabled, N 389 732
12 Months: AV Block 1st degree 90 159
12 Months: AV Block 2nd degree Type I 12 7
12 Months: AV Block 2nd degree Type II 7 7
12 Months: AV Block 3rd degree Intermittent 30 5
12 Months: AV Block 3rd degree Persistent 14 7
12 Months: None 216 523
6.Secondary Outcome
Title AV Block Status by Severity of Historical AV Block
Hide Description Frequencies of Subjects with AV Block Over Time by Severity of Historical AV Block
Time Frame 4 years post implant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Without History of AV Block Patients With History of AV Block
Hide Arm/Group Description:
Patients with MVP enabled and follow up data available
Patients with MVP enabled and follow up data available
Overall Number of Participants Analyzed 1098 541
Measure Type: Number
Unit of Measure: participants
6 Months: Subjects with MVP enabled 883 373
6 Months: AV Block 1st degree 49 221
6 Months: AV Block 2nd degree Type I 1 17
6 Months: AV Block 2nd degree Type II 1 25
6 Months: AV Block 3rd degree Intermittent 2 42
6 Months: AV Block 3rd degree Persistent 3 13
6 Months: None 818 35
12 Months: Subjects with MVP enabled 786 335
12 Months: AV Block 1st degree 73 176
12 Months: AV Block 2nd degree Type I 0 19
12 Months: AV Block 2nd degree Type II 1 13
12 Months: AV Block 3rd degree Intermittent 5 30
12 Months: AV Block 3rd degree Persistent 3 18
12 Months: None 689 50
24 Months: Subjects with MVP enabled 426 146
24 Months: AV Block 1st degree 51 95
24 Months: AV Block 2nd degree Type I 0 5
24 Months: AV Block 2nd degree Type II 0 3
24 Months: AV Block 3rd degree Intermittent 1 3
24 Months: AV Block 3rd degree Persistent 0 2
24 Months: None 362 24
36 Months: Subjects with MVP enabled 324 105
36 Months: AV Block 1st degree 58 69
36 Months: AV Block 2nd degree Type I 1 3
36 Months: AV Block 2nd degree Type II 0 2
36 Months: AV Block 3rd degree Intermittent 0 3
36 Months: AV Block 3rd degree Persistent 0 2
36 Months: None 253 18
48 Months: Subjects with MVP enabled 269 92
48 Months: AV Block 1st degree 59 59
48 Months: AV Block 2nd degree Type I 0 2
48 Months: AV Block 2nd degree Type II 0 1
48 Months: AV Block 3rd degree Intermittent 0 2
48 Months: AV Block 3rd degree Persistent 1 2
48 Months: None 201 17
7.Secondary Outcome
Title Summary of ATP Episodes Within All Treated Episodes
Hide Description Evaluate the utility of the Antitachycardia Pacing (ATP) During Charging feature of the device.
Time Frame 4 years post enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ATP During Charging
Hide Arm/Group Description:
Patients who had an episode and were programmed with the ATP during charging feature.
Overall Number of Participants Analyzed 343
Measure Type: Number
Unit of Measure: Episodes
Number of episodes analyzed from 343 participants 1584
Episodes with ATP attempted 1100
Episodes with Sucessful ATP 650
8.Secondary Outcome
Title Compare First Shock Rate Between Medtronic "PainFREE" Programming and "SCD-HeFT" Programming in Primary Prevention Study Participants.
Hide Description

First 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.

Time Frame 4 years post implant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title "PainFREE" Programming "SCD-HeFT" Programming
Hide Arm/Group Description:
OMNI “PainFREE” definition: programming combinations that result in ATP therapy for 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.
Overall Number of Participants Analyzed 1116 462
Mean (Standard Deviation)
Unit of Measure: rate
At implant 0  (0) 0  (0)
12 months after implant 0.10  (0.009) 0.15  (0.017)
24 months after implant 0.14  (0.011) 0.21  (0.019)
36 months after implant 0.18  (0.013) 0.24  (0.021)
48 months after implant 0.20  (0.014) 0.27  (0.023)
9.Secondary Outcome
Title Frequencies of Subjects With OptiVol Trends and Disease Progression.
Hide Description

Estimate 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'.

Time Frame 4 years post implant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 12-month Follow-up 24-month Follow-up 36-month Follow-up 48-month Follow-up
Hide Arm/Group Description:
Total subjects with disease progressed at 12 months
Total subjects with disease progressed at 24 months
Total subjects with disease progressed at 36 months
Total subjects with disease progressed at 48 months
Overall Number of Participants Analyzed 488 375 326 257
Measure Type: Number
Unit of Measure: participants
Disease Progressed, N 97 95 93 84
Crossed Threshold, N 382 327 287 224
Time Frame [Not Specified]
Adverse Event Reporting Description The Medtronic OMNI Study is a post-market observational study conducted in the United States (US). Adverse events were not collected as a part of the OMNI study. Sites were instructed to report applicable events in the same manner as required for any commercially available device, through the Medical Device Reporting (MDR) process.
 
Arm/Group Title [Not Specified]
Hide Arm/Group Description The Medtronic OMNI Study is a post-market observational study conducted in the United States (US). Adverse events were not collected as a part of the OMNI study. Sites were instructed to report applicable events in the same manner as required for any commercially available device, through the Medical Device Reporting (MDR) process.
All-Cause Mortality
[Not Specified]
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
[Not Specified]
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
[Not Specified]
Affected / at Risk (%)
Total   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Name/Title: Melinda Hoey, Clinical Research Specialist
Organization: Medtronic Cardiac Rhythm Disease Management
Phone: 763-526-2831
Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT00277524     History of Changes
Other Study ID Numbers: 601
First Submitted: January 12, 2006
First Posted: January 16, 2006
Results First Submitted: July 13, 2012
Results First Posted: August 28, 2013
Last Update Posted: August 28, 2013