Study Stopped
Ended follow-up after four years
OMNI Study--Assessing Therapies in Medtronic Pacemaker, Defibrillator, and Cardiac Resynchronization Therapy Devices.
OMNI
1 other identifier
observational
3,032
1 country
113
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2005
Longer than P75 for all trials
113 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 12, 2006
CompletedFirst Posted
Study publicly available on registry
January 16, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedResults Posted
Study results publicly available
August 28, 2013
CompletedAugust 28, 2013
May 1, 2013
5.3 years
January 12, 2006
July 13, 2012
May 21, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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.
Baseline
Secondary Outcomes (5)
AV Block Status by Device Type at 6 and 12 Months.
12 months post enrollment
AV Block Status by Severity of Historical AV Block
4 years post implant
Summary of ATP Episodes Within All Treated Episodes
4 years post enrollment
Compare First Shock Rate Between Medtronic "PainFREE" Programming and "SCD-HeFT" Programming in Primary Prevention Study Participants.
4 years post implant
Frequencies of Subjects With OptiVol Trends and Disease Progression.
4 years post implant
Study Arms (1)
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.
Eligibility Criteria
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.
You may qualify if:
- Implant of new or replacement study device. Enrollment must occur no later than 40 days post-implant.
- Study participants must be 18 years of age or older.
You may not qualify if:
- Study participants enrolled or intend to participate in another clinical device trial during the course of this study that required specific treatment or programming.
- Study participants unwilling and unable to comply with follow-up schedule.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtronic Cardiac Rhythm and Heart Failurelead
- Medtroniccollaborator
Study Sites (113)
Southern Arizona Health Care System
Tucson, Arizona, 85712-2836, United States
Arkansas Cardiology PA (Little Rock AR)
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
Related Publications (5)
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.
PMID: 15492306BACKGROUNDAlpert 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.
PMID: 10952831BACKGROUNDLamas 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.
PMID: 12950512BACKGROUNDBardy 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.
PMID: 15659722BACKGROUNDLiang KY, Zeger S. Longitudinal data analysis using generalized linear models. Biometrika, 1986, 73:13-22.
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Melinda Hoey, Clinical Research Specialist
- Organization
- Medtronic Cardiac Rhythm Disease Management
Study Officials
- PRINCIPAL INVESTIGATOR
Michael O. Sweeney
Cardiovascular Division Brigham and Womens
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2006
First Posted
January 16, 2006
Study Start
August 1, 2005
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
August 28, 2013
Results First Posted
August 28, 2013
Record last verified: 2013-05