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

Heart Failure, Congestive Clinical Trial

— OMNI  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00277524
• Other study ID #: 601
• Status: Terminated
• Phase: N/A
• First received: January 12, 2006
• Last updated: May 21, 2013
• Start date: August 2005
• Est. completion date: November 2010

Study information

• Verified date: May 2013
• Source: Medtronic Cardiac Rhythm Disease Management
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3032
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Bradycardia
• Heart Failure
• Heart Failure, Congestive
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Dysfunction
• Ventricular Fibrillation

Locations

Country	Name	City	State
United States	Albany Associates in Cardiology	Albany	New York
United States	Altoona Regional Health Center	Altoona	Pennsylvania
United States	Amarillo Heart Group	Amarillo	Texas
United States	University of Michigan Health System (UMHS) VA Medical Center	Ann Arbor	Michigan
United States	Cardiology Associates PC	Annapolis	Maryland
United States	King's Daughters Medical Center	Ashland	Kentucky
United States	Emory University Hospital	Atlanta	Georgia
United States	Bluestem Cardiology PC	Bartlesville	Oklahoma
United States	Cardio Research of New York Inc	Bayside	New York
United States	Midwest Cardiology PC	Belleville	Illinois
United States	Rocky Mountain Cardiology PC	Boulder	Colorado
United States	Cardiovascular Consultants (Cape Giradeau MO)	Cape Girardeau	Missouri
United States	Cardiologists PC	Cedar Rapids	Iowa
United States	CAMC Institute Clinical Trials Center	Charleston	West Virginia
United States	Sanger Heart and Vascular Institute-Charlotte	Charlotte	North Carolina
United States	TriHealth Good Samaritan Hos	Cincinnati	Ohio
United States	Pikes Peak Cardiology	Colorado Springs	Colorado
United States	Columbia Heart Clinic PA	Columbia	South Carolina
United States	Cardiovascular Associates LLC	Covington	Louisiana
United States	Dallas VA Medical Center	Dallas	Texas
United States	Daytona Heart	Daytona Beach	Florida
United States	New Jersey Heart (Elizabeth NJ)	Elizabeth	New Jersey
United States	Cardiovascular Associates	Elk Grove Village	Illinois
United States	EMH Elyria Medical Center	Elyria	Ohio
United States	Englewood Hospital & Medical Center	Englewood	New Jersey
United States	The Heart Group PC	Evansville	Indiana
United States	Internal Medicine & Cardiology Associates of Southeastern New England PC	Fall River	Massachusetts
United States	Pee Dee Cardiology	Florence	South Carolina
United States	Florida Arrhythmia Consultants	Fort Lauderdale	Florida
United States	Cardiovascular Specialists of Frederick	Frederick	Maryland
United States	California Heart Medical Associates	Fresno	California
United States	Heart Care Inc	Gahanna	Ohio
United States	Northeast Georgia Heart Center PC	Gainesville	Georgia
United States	The Heart Center	Glen Burnie	Maryland
United States	Genesys Regional Medical Center	Grand Blanc	Michigan
United States	Altru Hospital	Grand Forks	North Dakota
United States	Heart Rhythm Associates PLLC	Greenville	North Carolina
United States	Piedmont Cardiology Associates (Greenwood SC)	Greenwood	South Carolina
United States	Hattiesburg Clinic/Forrest General	Hattiesburg	Mississippi
United States	High Point Regional Health System	High Point	North Carolina
United States	Saint Mary Medical Center (Community Healthcare System)	Hobart	Indiana
United States	Edward N Shen MD Inc	Honolulu	Hawaii
United States	Hall Garcia Cardiology Associates	Houston	Texas
United States	Apex Cardiology	Inglewood	California
United States	Borgess Medical Center	Kalamazoo	Michigan
United States	Scripps Green Hospital Scripps Clinic Torrey Pines	La Jolla	California
United States	Clark & Daughtrey Medical Group PA	Lakeland	Florida
United States	Cardiology Consultants of East Michigan	Lapeer	Michigan
United States	Northern California Heart Care	Larkspur	California
United States	Arkansas Cardiology PA (Little Rock AR)	Little Rock	Arkansas
United States	University Medical Associates	Louisville	Kentucky
United States	Macon Electrophysiology Associates PC	Macon	Georgia
United States	Wisconsin Heart SC	Madison	Wisconsin
United States	Stark Medical Specialties Inc	Massillon	Ohio
United States	Heart Clinic PLLC	McAllen	Texas
United States	Melbourne Internal Medicine Associates / Century Research Associates	Melbourne	Florida
United States	Memphis Heart Clinic	Memphis	Tennessee
United States	Heart Consultants	Midwest City	Oklahoma
United States	University of Minnesota	Minneapolis	Minnesota
United States	Mission Internal Medical Group	Mission Viejo	California
United States	James H Quillen VA Medical Center	Mountain Home	Tennessee
United States	New Bedford Medical Associates	New Bedford	Massachusetts
United States	Arrhythmia Associates of New York	New York	New York
United States	Heartwise Cardiology	New York	New York
United States	New York Medical Center of Queens	New York City	New York
United States	Arrhythmia Institute	Newtown	Pennsylvania
United States	Medical Center Hospital Odessa	Odessa	Texas
United States	Utah Cardiology (Ogden UT)	Ogden	Utah
United States	Terrance Khastgir MD PC	Oklahoma City	Oklahoma
United States	Heart Consultants PC	Omaha	Nebraska
United States	Orange County Heart Institute & Research Center	Orange	California
United States	C. Raghavan MD PA	Orlando	Florida
United States	Foothill Cardiology	Pasadena	California
United States	Saint Joseph's Regional Medical Center	Paterson	New Jersey
United States	Northwest Florida Heart Group PA	Pensacola	Florida
United States	Cardiology Consultants of Philadelphia	Philadelphia	Pennsylvania
United States	Pacific Heart Associates	Portland	Oregon
United States	Marshall-Rismiller & Associates	Pottsville	Pennsylvania
United States	Wake Heart & Vascular Associates	Raleigh	North Carolina
United States	Desert Cardiology Center / Desert Cardiology Medical Group Consultants	Rancho Mirage	California
United States	Baltimore Heart Associates (Randallstown MD)	Randallstown	Maryland
United States	Reno Heart Physicians	Reno	Nevada
United States	Virginia Cardiovascular Specialists PC	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	University Cardiovascular Associates (UCVA)	Rochester	New York
United States	Shady Grove Adventist Hospital	Rockville	Maryland
United States	Heart & Vascular Institute of Florida	Safety Harbor	Florida
United States	Saint Louis Heart & Vascular PC	Saint Louis	Missouri
United States	North Shore Cardiology Associates	Salem	Massachusetts
United States	Peninsula Cardiology Associates	Salisbury	Maryland
United States	Cardiology Clinic of San Antonio	San Antonio	Texas
United States	Brett Berman Cardiology & Cardiac Electrophysiology	San Diego	California
United States	Dwain L Coggins MD FACC	San Jose	California
United States	Cardiovascular Consultants (Savannah GA)	Savannah	Georgia
United States	Cardiology Associates of Schenectady PC	Schenectady	New York
United States	Saint Catherine of Sienna Medical Center	Smithtown	New York
United States	Cardiovascular Clinical Associates PC	Southfield	Michigan
United States	Ohio Institute of Cardiac Care Inc	Springfield	Ohio
United States	Great Lakes Heart and Vascular Institute PC	St. Joseph	Michigan
United States	Cardiology Consultants of Saint Louis County PC	St. Louis	Missouri
United States	Saint Paul Cardiology	St. Paul	Minnesota
United States	Florida Cardiovascular Institute PA	Tampa	Florida
United States	Cardiology Clinic of San Antonio	Tarzana	California
United States	The Toledo Clinic	Toledo	Ohio
United States	Erol Kosar MD Inc	Torrance	California
United States	Interventional Cardiac Consultants PLC	Trinity	Florida
United States	Southern Arizona Health Care System	Tucson	Arizona
United States	Cardiovascular Associates of East Texas PA	Tyler	Texas
United States	Arrhythmia Consultants of Milwaukee SC	Wauwatosa	Wisconsin
United States	Cardiology Associates	West Paterson	New Jersey
United States	Wilmington Cardiology LLC	Wilmington	North Carolina
United States	Forsyth Medical Center	Winston-Salem	North Carolina
United States	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm Disease Management	Medtronic

Country where clinical trial is conducted

United States, 

References & Publications (5)

Alpert JS. Are data from clinical registries of any value? Eur Heart J. 2000 Sep;21(17):1399-401. — View Citation

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. Erratum in: N Engl J Med. 2005 May 19;352(20):2146. — View Citation

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. — View Citation

Liang KY, Zeger S. Longitudinal data analysis using generalized linear models. Biometrika, 1986, 73:13-22.

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. Epub 2004 Oct 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implanted Systems Frequencies	Frequencies of implanted systems were measured among patients who were implanted with a device (IPT, ICD or CRT-D).	Baseline	No
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.	Baseline	No
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.	Baseline	No
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.	Baseline	No
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.	12 months post enrollment	No
Secondary	AV Block Status by Severity of Historical AV Block	Frequencies of Subjects with AV Block Over Time by Severity of Historical AV Block	4 years post implant	No
Secondary	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	No
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.	4 years post implant	No
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: The NYHA classification number increases (example: I to II), or; The LVEF decreases by at least 20% (relative difference) and by at least a 5% absolute difference, or; The subject expires; A subject who crossed OptiVol threshold since last visit was regarded as 'crossed threshold'.	4 years post implant	No