Not provided
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Ended follow-up after four years
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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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The purpose of the OMNI study is to characterize therapy and diagnostic utilization in study participants implanted with study devices and to describe Implantable Cardioverter Defibrillator(ICD)therapy utilization for life threatening arrhythmias in primary and secondary prevention study participants. This study will assess therapies in Medtronic pacemaker, defibrillator, and cardiac resynchronization therapy devices.
The first therapy is for reducing unnecessary pacing in pacemaker patients. The second therapy provides pacing therapy in an attempt to stop fast or life threatening ventricular arrhythmias in lieu of delivering a defibrillation shock. The third therapy is a diagnostic measurement of a patient's fluid status and provides the physician information on the patient's heart failure status.
The study will also assess the time to a patient's first defibrillation shock and will verify that the shock was for a fast or life threatening ventricular rhythm.
The OMNI results demonstrate the importance of Medtronic's ongoing efforts to increase adoption of evidence based shock-reduction programming strategies. Longer VF NID (number of intervals to detect in the VF zone) should be utilized with the Anti-tachycardia Pacing (ATP) During Charging Feature. ATP during Charging allows physicians to treat with ATP without delay to shock. Therefore, VF NID may be extended to allow episodes the chance to self-terminate immediately to shock by use of the ATP during the charging feature.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Overall | All patients enrolled in OMNI. Patient sub-groups include device type, history of atrial fibrillation (AF), history of investigate atrioventricular (AV) block, implant indication, and managed ventricular pacing (MVP) enabled. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Implanted Systems Frequencies | Frequencies of implanted systems were measured among patients who were implanted with a device (IPT, ICD or CRT-D). | Baseline |
| Implantable Pulse Generator (IPG) Device Baseline Programming Frequencies. | 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. | Baseline |
| ICD/CRT-D Device Baseline Programming Frequencies | 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. | Baseline |
| ICD/CRT-D Device Baseline Programming Measurements | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| AV Block Status by Device Type at 6 and 12 Months. | Frequencies of subject with AV block over time between ICD and Implantable Pulse Generator(IPG) study participants. | 12 months post enrollment |
| AV Block Status by Severity of Historical AV Block |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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Patients receiving a specified Medtronic Implantable Pulse Generator(IPG), Implantable Cardioverter Defibrillator(ICD), or Cardiac Resynchronization Therapy-Defibrillator(CRT-D) device where informed consent and/or authorization to use and disclose health information permission has been granted.
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| Name | Affiliation | Role |
|---|---|---|
| Michael O. Sweeney | Cardiovascular Division Brigham and Womens | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Arizona Health Care System | Tucson | Arizona | 85712-2836 | United States | ||
| Arkansas Cardiology PA (Little Rock AR) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15492306 | Background | Wathen MS, DeGroot PJ, Sweeney MO, Stark AJ, Otterness MF, Adkisson WO, Canby RC, Khalighi K, Machado C, Rubenstein DS, Volosin KJ; PainFREE Rx II Investigators. Prospective randomized multicenter trial of empirical antitachycardia pacing versus shocks for spontaneous rapid ventricular tachycardia in patients with implantable cardioverter-defibrillators: Pacing Fast Ventricular Tachycardia Reduces Shock Therapies (PainFREE Rx II) trial results. Circulation. 2004 Oct 26;110(17):2591-6. doi: 10.1161/01.CIR.0000145610.64014.E4. Epub 2004 Oct 18. | |
| 10952831 |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects With IPG | Subjects implanted with an implantable pulse generator (IPG). |
| FG001 | Subjects With Single Chamber ICD | Subjects implanted with a single chamber implantable cardioverter defibrillator (ICD). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline |
Frequencies of Subjects with AV Block Over Time by Severity of Historical AV Block
| 4 years post implant |
| Summary of ATP Episodes Within All Treated Episodes | Evaluate the utility of the Antitachycardia Pacing (ATP) During Charging feature of the device. | 4 years post enrollment |
| Compare First Shock Rate Between Medtronic "PainFREE" Programming and "SCD-HeFT" Programming in Primary Prevention Study Participants. | 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. | 4 years post implant |
| Frequencies of Subjects With OptiVol Trends and Disease Progression. | Estimate the correlation between OptiVol trends and disease progression. A subject's disease status was said to have progressed if:
A subject who crossed OptiVol threshold since last visit was regarded as 'crossed threshold'. | 4 years post implant |
| Little Rock |
| Arkansas |
| 72205-6231 |
| United States |
| California Heart Medical Associates | Fresno | California | 93720 | United States |
| Apex Cardiology | Inglewood | California | 90301-4057 | United States |
| Scripps Green Hospital Scripps Clinic Torrey Pines | La Jolla | California | 92037-1027 | United States |
| Northern California Heart Care | Larkspur | California | 94939 | United States |
| Mission Internal Medical Group | Mission Viejo | California | 92691-6384 | United States |
| Orange County Heart Institute & Research Center | Orange | California | 92868 | United States |
| Foothill Cardiology | Pasadena | California | 91105 | United States |
| Desert Cardiology Center / Desert Cardiology Medical Group Consultants | Rancho Mirage | California | 92270 | United States |
| Brett Berman Cardiology & Cardiac Electrophysiology | San Diego | California | 92103 | United States |
| Dwain L Coggins MD FACC | San Jose | California | 95124 | United States |
| Cardiology Clinic of San Antonio | Tarzana | California | 91356 | United States |
| Erol Kosar MD Inc | Torrance | California | 90503 | United States |
| Rocky Mountain Cardiology PC | Boulder | Colorado | 80304 | United States |
| Pikes Peak Cardiology | Colorado Springs | Colorado | 80909 | United States |
| Daytona Heart | Daytona Beach | Florida | 32114 | United States |
| Florida Arrhythmia Consultants | Fort Lauderdale | Florida | 33308 | United States |
| Clark & Daughtrey Medical Group PA | Lakeland | Florida | 33803 | United States |
| Melbourne Internal Medicine Associates / Century Research Associates | Melbourne | Florida | 32901 | United States |
| C. Raghavan MD PA | Orlando | Florida | 32819 | United States |
| Northwest Florida Heart Group PA | Pensacola | Florida | 32514 | United States |
| Heart & Vascular Institute of Florida | Safety Harbor | Florida | 34695-6604 | United States |
| Florida Cardiovascular Institute PA | Tampa | Florida | 33609 | United States |
| Interventional Cardiac Consultants PLC | Trinity | Florida | 34655 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| Northeast Georgia Heart Center PC | Gainesville | Georgia | 30501 | United States |
| Macon Electrophysiology Associates PC | Macon | Georgia | 31201 | United States |
| Cardiovascular Consultants (Savannah GA) | Savannah | Georgia | 31404 | United States |
| Edward N Shen MD Inc | Honolulu | Hawaii | 96813 | United States |
| Midwest Cardiology PC | Belleville | Illinois | 62226 | United States |
| Cardiovascular Associates | Elk Grove Village | Illinois | 60007 | United States |
| The Heart Group PC | Evansville | Indiana | 47710-1656 | United States |
| Saint Mary Medical Center (Community Healthcare System) | Hobart | Indiana | 46342 | United States |
| Cardiologists PC | Cedar Rapids | Iowa | 52403 | United States |
| King's Daughters Medical Center | Ashland | Kentucky | 41101-2843 | United States |
| University Medical Associates | Louisville | Kentucky | 40202-1901 | United States |
| Cardiovascular Associates LLC | Covington | Louisiana | 70433 | United States |
| Cardiology Associates PC | Annapolis | Maryland | 21401 | United States |
| Cardiovascular Specialists of Frederick | Frederick | Maryland | 21702 | United States |
| The Heart Center | Glen Burnie | Maryland | 21061-5613 | United States |
| Baltimore Heart Associates (Randallstown MD) | Randallstown | Maryland | 21133-4707 | United States |
| Shady Grove Adventist Hospital | Rockville | Maryland | 20850 | United States |
| Peninsula Cardiology Associates | Salisbury | Maryland | 21804 | United States |
| Internal Medicine & Cardiology Associates of Southeastern New England PC | Fall River | Massachusetts | 02720 | United States |
| New Bedford Medical Associates | New Bedford | Massachusetts | 02740 | United States |
| North Shore Cardiology Associates | Salem | Massachusetts | 01970 | United States |
| University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | 01655-0002 | United States |
| University of Michigan Health System (UMHS) VA Medical Center | Ann Arbor | Michigan | 48105-2303 | United States |
| Genesys Regional Medical Center | Grand Blanc | Michigan | 48439 | United States |
| Borgess Medical Center | Kalamazoo | Michigan | 49048 | United States |
| Cardiology Consultants of East Michigan | Lapeer | Michigan | 48446 | United States |
| Great Lakes Heart and Vascular Institute PC | Saint Joseph | Michigan | 49085 | United States |
| Cardiovascular Clinical Associates PC | Southfield | Michigan | 48034 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455-0368 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905-0001 | United States |
| Saint Paul Cardiology | Saint Paul | Minnesota | 55102-1036 | United States |
| Hattiesburg Clinic/Forrest General | Hattiesburg | Mississippi | 39401 | United States |
| Cardiovascular Consultants (Cape Giradeau MO) | Cape Girardeau | Missouri | 63703 | United States |
| Cardiology Consultants of Saint Louis County PC | St Louis | Missouri | 63128 | United States |
| Saint Louis Heart & Vascular PC | St Louis | Missouri | 63136-6111 | United States |
| Heart Consultants PC | Omaha | Nebraska | 68122 | United States |
| Reno Heart Physicians | Reno | Nevada | 89503-4541 | United States |
| New Jersey Heart (Elizabeth NJ) | Elizabeth | New Jersey | 07202 | United States |
| Englewood Hospital & Medical Center | Englewood | New Jersey | 07631 | United States |
| Saint Joseph's Regional Medical Center | Paterson | New Jersey | 07503 | United States |
| Cardiology Associates | Woodland Park | New Jersey | 07424 | United States |
| Albany Associates in Cardiology | Albany | New York | 12205-1438 | United States |
| Cardio Research of New York Inc | Bayside | New York | 11361 | United States |
| New York Medical Center of Queens | New York | New York | 10001 | United States |
| Heartwise Cardiology | New York | New York | 10016 | United States |
| Arrhythmia Associates of New York | New York | New York | 10028-1802 | United States |
| University Cardiovascular Associates (UCVA) | Rochester | New York | 14618-2663 | United States |
| Cardiology Associates of Schenectady PC | Schenectady | New York | 12304 | United States |
| Saint Catherine of Sienna Medical Center | Smithtown | New York | 11787-1628 | United States |
| Sanger Heart and Vascular Institute-Charlotte | Charlotte | North Carolina | 28203 | United States |
| Heart Rhythm Associates PLLC | Greenville | North Carolina | 27834 | United States |
| High Point Regional Health System | High Point | North Carolina | 27262 | United States |
| Wake Heart & Vascular Associates | Raleigh | North Carolina | 27610-1231 | United States |
| Wilmington Cardiology LLC | Wilmington | North Carolina | 28403-5345 | United States |
| Forsyth Medical Center | Winston-Salem | North Carolina | 27103 | United States |
| Altru Hospital | Grand Forks | North Dakota | 58201-4032 | United States |
| TriHealth Good Samaritan Hos | Cincinnati | Ohio | 45220-2475 | United States |
| EMH Elyria Medical Center | Elyria | Ohio | 44035 | United States |
| Heart Care Inc | Gahanna | Ohio | 43230 | United States |
| Stark Medical Specialties Inc | Massillon | Ohio | 44646 | United States |
| Ohio Institute of Cardiac Care Inc | Springfield | Ohio | 45504 | United States |
| The Toledo Clinic | Toledo | Ohio | 43623-4231 | United States |
| Bluestem Cardiology PC | Bartlesville | Oklahoma | 74006 | United States |
| Heart Consultants | Midwest City | Oklahoma | 73110 | United States |
| Terrance Khastgir MD PC | Oklahoma City | Oklahoma | 73112-4457 | United States |
| Pacific Heart Associates | Portland | Oregon | 97227 | United States |
| Altoona Regional Health Center | Altoona | Pennsylvania | 16601-4804 | United States |
| Arrhythmia Institute | Newtown | Pennsylvania | 18940-1885 | United States |
| Cardiology Consultants of Philadelphia | Philadelphia | Pennsylvania | 19107 | United States |
| Marshall-Rismiller & Associates | Pottsville | Pennsylvania | 17901 | United States |
| Columbia Heart Clinic PA | Columbia | South Carolina | 29203 | United States |
| Pee Dee Cardiology | Florence | South Carolina | 29506 | United States |
| Piedmont Cardiology Associates (Greenwood SC) | Greenwood | South Carolina | 29646 | United States |
| Memphis Heart Clinic | Memphis | Tennessee | 38120 | United States |
| James H Quillen VA Medical Center | Mountain Home | Tennessee | 37604 | United States |
| Amarillo Heart Group | Amarillo | Texas | 79106-2430 | United States |
| Dallas VA Medical Center | Dallas | Texas | 75216 | United States |
| Hall Garcia Cardiology Associates | Houston | Texas | 77030-2309 | United States |
| Heart Clinic PLLC | McAllen | Texas | 78503 | United States |
| Medical Center Hospital Odessa | Odessa | Texas | 76761 | United States |
| Cardiology Clinic of San Antonio | San Antonio | Texas | 78229 | United States |
| Cardiovascular Associates of East Texas PA | Tyler | Texas | 75701 | United States |
| Utah Cardiology (Ogden UT) | Ogden | Utah | 84405-7420 | United States |
| Virginia Cardiovascular Specialists PC | Richmond | Virginia | 23226-1928 | United States |
| CAMC Institute Clinical Trials Center | Charleston | West Virginia | 25304 | United States |
| Wisconsin Heart SC | Madison | Wisconsin | 53713-2319 | United States |
| Arrhythmia Consultants of Milwaukee SC | Wauwatosa | Wisconsin | 53226-4362 | United States |
| Background |
| Alpert JS. Are data from clinical registries of any value? Eur Heart J. 2000 Sep;21(17):1399-401. doi: 10.1053/euhj.2000.2265. No abstract available. |
| 12950512 | Background | Lamas GA, Williams A. Have the results of randomized clinical trials of pacing altered the practice of cardiac pacing? J Cardiovasc Electrophysiol. 2003 Sep;14(9 Suppl):S15-9. doi: 10.1046/j.1540-8167.14.s9.14.x. |
| 15659722 | Background | Bardy GH, Lee KL, Mark DB, Poole JE, Packer DL, Boineau R, Domanski M, Troutman C, Anderson J, Johnson G, McNulty SE, Clapp-Channing N, Davidson-Ray LD, Fraulo ES, Fishbein DP, Luceri RM, Ip JH; Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005 Jan 20;352(3):225-37. doi: 10.1056/NEJMoa043399. |
| Background | Liang KY, Zeger S. Longitudinal data analysis using generalized linear models. Biometrika, 1986, 73:13-22. |
| FG002 | Subjects With Dual Chamber ICD | Subjects implanted with a dual chamber implantable cardioverter defibrillator (ICD). |
| FG003 | Subjects With CRT-D | Subjects implanted with a cardiac resynchronization therapy defibrillator (CRT-D). |
| COMPLETED |
|
| NOT COMPLETED |
|
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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Overall | All patients enrolled in OMNI. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | 2817 subjects had information on race or ethnic origin. | Number | participants |
| ||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Weight | 2781 subjects had information on weight. | Mean | Standard Deviation | lbs |
| |||||||||||||||||||||
| QRS duration | 2132 subjects had information on QRS duration. | Mean | Standard Deviation | ms |
| |||||||||||||||||||||
| PR interval | 1829 subjects had information on PR interval. | Mean | Standard Deviation | ms |
| |||||||||||||||||||||
| LVEF(%) | 2487 subjects had information on left ventricular ejection fraction (LVEF, %). | Mean | Standard Deviation | participants |
| |||||||||||||||||||||
| New York Heart Association (NYHA) classification | 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). | Number | participants |
| ||||||||||||||||||||||
| Heart failure (HF) stage | 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 | participants |
| ||||||||||||||||||||||
| Number of patients implanted | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Implanted Systems Frequencies | Frequencies of implanted systems were measured among patients who were implanted with a device (IPT, ICD or CRT-D). | Posted | Number | participants | Baseline |
|
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Implantable Pulse Generator (IPG) Device Baseline Programming Frequencies. | 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. | Posted | Number | participants | Baseline |
|
| ||||||||||||||||||||||||||||||||||||||
| Primary | ICD/CRT-D Device Baseline Programming Frequencies | 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. | Posted | Number | participants | Baseline | ICD/CRT-D Devices | Participants |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | AV Block Status by Device Type at 6 and 12 Months. | Frequencies of subject with AV block over time between ICD and Implantable Pulse Generator(IPG) study participants. | Posted | Number | participants | 12 months post enrollment |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | AV Block Status by Severity of Historical AV Block | Frequencies of Subjects with AV Block Over Time by Severity of Historical AV Block | Posted | Number | participants | 4 years post implant |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Summary of ATP Episodes Within All Treated Episodes | Evaluate the utility of the Antitachycardia Pacing (ATP) During Charging feature of the device. | Posted | Number | Episodes | 4 years post enrollment |
|
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Compare First Shock Rate Between Medtronic "PainFREE" Programming and "SCD-HeFT" Programming in Primary Prevention Study Participants. | 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. | Posted | Mean | Standard Deviation | rate | 4 years post implant |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Frequencies of Subjects With OptiVol Trends and Disease Progression. | Estimate the correlation between OptiVol trends and disease progression. A subject's disease status was said to have progressed if:
A subject who crossed OptiVol threshold since last visit was regarded as 'crossed threshold'. | Posted | Number | participants | 4 years post implant |
| |||||||||||||||||||||||||||||||||||||||
| Primary | ICD/CRT-D Device Baseline Programming Measurements | 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. | Posted | Mean | Standard Deviation | ms | Baseline |
|
|
Not provided
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melinda Hoey, Clinical Research Specialist | Medtronic Cardiac Rhythm Disease Management | 763-526-2831 | Melinda.hoey@medtronic.com |
| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| D006333 | Heart Failure |
| D014693 | Ventricular Fibrillation |
| D018754 | Ventricular Dysfunction |
| D001919 | Bradycardia |
| D001145 | Arrhythmias, Cardiac |
| D013610 | Tachycardia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Black |
|
| Hispanic |
|
| Native Hawaiian |
|
| White |
|
| Other |
|
| III |
|
| IV |
|
| No Heart Failure |
|
| Missing |
|
| C |
|
| D |
|
| No HF |
|
| NA |
|
| Title | Measurements |
|---|---|
|
| InSync Sentry (7297) |
|
| InSync Sentry (7299) |
|
| Intrinsic DR (7288) |
|
|
| ICD/CRT-D Devices |
|
|
|
|
| Categories |
|---|
| Number of episodes analyzed from 343 participants |
| |||||
| Episodes with ATP attempted |
| |||||
| Episodes with Sucessful ATP |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|