Clinical trial NCT00277524: OMNI Study--Assessing Therapies in Medtronic Pacemaker, Defibrillator, and Cardiac Resynchronization Therapy Devices.
Official title: OMNI Study--Assessing Therapies in Medtronic Pacemaker, Defibrillator, and Cardiac Resynchronization Therapy Devices.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Tachycardia, Ventricular
Heart Failure, Congestive
Ventricular Fibrillation
Ventricular Dysfunction
Bradycardia
Keywords: Pacemaker
Defibrillator
Cardiac Resynchronization
Dysynchrony
Heart failure
Arrhythmia
Tachycardia
Bradycardia
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2006-01-16
Enrollment: 3032
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Implanted Systems Frequencies
timeFrame: Baseline
measure: Implantable Pulse Generator (IPG) Device Baseline Programming Frequencies.
timeFrame: Baseline
measure: ICD/CRT-D Device Baseline Programming Frequencies
timeFrame: Baseline
measure: ICD/CRT-D Device Baseline Programming Measurements
timeFrame: Baseline
Secondary outcomes:
measure: AV Block Status by Device Type at 6 and 12 Months.
timeFrame: 12 months post enrollment
measure: AV Block Status by Severity of Historical AV Block
timeFrame: 4 years post implant
measure: Summary of ATP Episodes Within All Treated Episodes
timeFrame: 4 years post enrollment
measure: Compare First Shock Rate Between Medtronic "PainFREE" Programming and "SCD-HeFT" Programming in Primary Prevention Study Participants.
timeFrame: 4 years post implant
measure: Frequencies of Subjects With OptiVol Trends and Disease Progression.
timeFrame: 4 years post implant
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Southern Arizona Health Care System
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Cardiology PA (Little Rock AR)
state: Arkansas
city: Fresno
country: United States
facility: California Heart Medical Associates
state: California
city: Inglewood
country: United States
facility: Apex Cardiology
state: California
city: La Jolla
country: United States
facility: Scripps Green Hospital Scripps Clinic Torrey Pines
state: California
city: Larkspur
country: United States
facility: Northern California Heart Care
state: California
city: Mission Viejo
country: United States
facility: Mission Internal Medical Group
state: California
city: Orange
country: United States
facility: Orange County Heart Institute & Research Center
state: California
city: Pasadena
country: United States
facility: Foothill Cardiology
state: California
city: Rancho Mirage
country: United States
facility: Desert Cardiology Center / Desert Cardiology Medical Group Consultants
state: California
city: San Diego
country: United States
facility: Brett Berman Cardiology & Cardiac Electrophysiology
state: California
city: San Jose
country: United States
facility: Dwain L Coggins MD FACC
state: California
city: Tarzana
country: United States
facility: Cardiology Clinic of San Antonio
state: California
city: Torrance
country: United States
facility: Erol Kosar MD Inc
state: California
city: Boulder
country: United States
facility: Rocky Mountain Cardiology PC
state: Colorado
city: Colorado Springs
country: United States
facility: Pikes Peak Cardiology
state: Colorado
city: Daytona Beach
country: United States
facility: Daytona Heart
state: Florida
city: Fort Lauderdale
country: United States
facility: Florida Arrhythmia Consultants
state: Florida
city: Lakeland
country: United States
facility: Clark & Daughtrey Medical Group PA
state: Florida
city: Melbourne
country: United States
facility: Melbourne Internal Medicine Associates / Century Research Associates
state: Florida
city: Orlando
country: United States
facility: C. Raghavan MD PA
state: Florida
city: Pensacola
country: United States
facility: Northwest Florida Heart Group PA
state: Florida
city: Safety Harbor
country: United States
facility: Heart & Vascular Institute of Florida
state: Florida
city: Tampa
country: United States
facility: Florida Cardiovascular Institute PA
state: Florida
city: Trinity
country: United States
facility: Interventional Cardiac Consultants PLC
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Gainesville
country: United States
facility: Northeast Georgia Heart Center PC
state: Georgia
city: Macon
country: United States
facility: Macon Electrophysiology Associates PC
state: Georgia
city: Savannah
country: United States
facility: Cardiovascular Consultants (Savannah GA)
state: Georgia
city: Honolulu
country: United States
facility: Edward N Shen MD Inc
state: Hawaii
city: Belleville
country: United States
facility: Midwest Cardiology PC
state: Illinois
city: Elk Grove Village
country: United States
facility: Cardiovascular Associates
state: Illinois
city: Evansville
country: United States
facility: The Heart Group PC
state: Indiana
city: Hobart
country: United States
facility: Saint Mary Medical Center (Community Healthcare System)
state: Indiana
city: Cedar Rapids
country: United States
facility: Cardiologists PC
state: Iowa
city: Ashland
country: United States
facility: King's Daughters Medical Center
state: Kentucky
city: Louisville
country: United States
facility: University Medical Associates
state: Kentucky
city: Covington
country: United States
facility: Cardiovascular Associates LLC
state: Louisiana
city: Annapolis
country: United States
facility: Cardiology Associates PC
state: Maryland
city: Frederick
country: United States
facility: Cardiovascular Specialists of Frederick
state: Maryland
city: Glen Burnie
country: United States
facility: The Heart Center
state: Maryland
city: Randallstown
country: United States
facility: Baltimore Heart Associates (Randallstown MD)
state: Maryland
city: Rockville
country: United States
facility: Shady Grove Adventist Hospital
state: Maryland
city: Salisbury
country: United States
facility: Peninsula Cardiology Associates
state: Maryland
city: Fall River
country: United States
facility: Internal Medicine & Cardiology Associates of Southeastern New England PC
state: Massachusetts
city: New Bedford
country: United States
facility: New Bedford Medical Associates
state: Massachusetts
city: Salem
country: United States
facility: North Shore Cardiology Associates
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Memorial Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System (UMHS) VA Medical Center
state: Michigan
city: Grand Blanc
country: United States
facility: Genesys Regional Medical Center
state: Michigan
city: Kalamazoo
country: United States
facility: Borgess Medical Center
state: Michigan
city: Lapeer
country: United States
facility: Cardiology Consultants of East Michigan
state: Michigan
city: Southfield
country: United States
facility: Cardiovascular Clinical Associates PC
state: Michigan
city: St. Joseph
country: United States
facility: Great Lakes Heart and Vascular Institute PC
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: St. Paul
country: United States
facility: Saint Paul Cardiology
state: Minnesota
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic/Forrest General
state: Mississippi
city: Cape Girardeau
country: United States
facility: Cardiovascular Consultants (Cape Giradeau MO)
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis Heart & Vascular PC
state: Missouri
city: St. Louis
country: United States
facility: Cardiology Consultants of Saint Louis County PC
state: Missouri
city: Omaha
country: United States
facility: Heart Consultants PC
state: Nebraska
city: Reno
country: United States
facility: Reno Heart Physicians
state: Nevada
city: Elizabeth
country: United States
facility: New Jersey Heart (Elizabeth NJ)
state: New Jersey
city: Englewood
country: United States
facility: Englewood Hospital & Medical Center
state: New Jersey
city: Paterson
country: United States
facility: Saint Joseph's Regional Medical Center
state: New Jersey
city: West Paterson
country: United States
facility: Cardiology Associates
state: New Jersey
city: Albany
country: United States
facility: Albany Associates in Cardiology
state: New York
city: Bayside
country: United States
facility: Cardio Research of New York Inc
state: New York
city: New York City
country: United States
facility: New York Medical Center of Queens
state: New York
city: New York
country: United States
facility: Heartwise Cardiology
state: New York
city: New York
country: United States
facility: Arrhythmia Associates of New York
state: New York
city: Rochester
country: United States
facility: University Cardiovascular Associates (UCVA)
state: New York
city: Schenectady
country: United States
facility: Cardiology Associates of Schenectady PC
state: New York
city: Smithtown
country: United States
facility: Saint Catherine of Sienna Medical Center
state: New York
city: Charlotte
country: United States
facility: Sanger Heart and Vascular Institute-Charlotte
state: North Carolina
city: Greenville
country: United States
facility: Heart Rhythm Associates PLLC
state: North Carolina
city: High Point
country: United States
facility: High Point Regional Health System
state: North Carolina
city: Raleigh
country: United States
facility: Wake Heart & Vascular Associates
state: North Carolina
city: Wilmington
country: United States
facility: Wilmington Cardiology LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: Forsyth Medical Center
state: North Carolina
city: Grand Forks
country: United States
facility: Altru Hospital
state: North Dakota
city: Cincinnati
country: United States
facility: TriHealth Good Samaritan Hos
state: Ohio
city: Elyria
country: United States
facility: EMH Elyria Medical Center
state: Ohio
city: Gahanna
country: United States
facility: Heart Care Inc
state: Ohio
city: Massillon
country: United States
facility: Stark Medical Specialties Inc
state: Ohio
city: Springfield
country: United States
facility: Ohio Institute of Cardiac Care Inc
state: Ohio
city: Toledo
country: United States
facility: The Toledo Clinic
state: Ohio
city: Bartlesville
country: United States
facility: Bluestem Cardiology PC
state: Oklahoma
city: Midwest City
country: United States
facility: Heart Consultants
state: Oklahoma
city: Oklahoma City
country: United States
facility: Terrance Khastgir MD PC
state: Oklahoma
city: Portland
country: United States
facility: Pacific Heart Associates
state: Oregon
city: Altoona
country: United States
facility: Altoona Regional Health Center
state: Pennsylvania
city: Newtown
country: United States
facility: Arrhythmia Institute
state: Pennsylvania
city: Philadelphia
country: United States
facility: Cardiology Consultants of Philadelphia
state: Pennsylvania
city: Pottsville
country: United States
facility: Marshall-Rismiller & Associates
state: Pennsylvania
city: Columbia
country: United States
facility: Columbia Heart Clinic PA
state: South Carolina
city: Florence
country: United States
facility: Pee Dee Cardiology
state: South Carolina
city: Greenwood
country: United States
facility: Piedmont Cardiology Associates (Greenwood SC)
state: South Carolina
city: Memphis
country: United States
facility: Memphis Heart Clinic
state: Tennessee
city: Mountain Home
country: United States
facility: James H Quillen VA Medical Center
state: Tennessee
city: Amarillo
country: United States
facility: Amarillo Heart Group
state: Texas
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
city: Houston
country: United States
facility: Hall Garcia Cardiology Associates
state: Texas
city: McAllen
country: United States
facility: Heart Clinic PLLC
state: Texas
city: Odessa
country: United States
facility: Medical Center Hospital Odessa
state: Texas
city: San Antonio
country: United States
facility: Cardiology Clinic of San Antonio
state: Texas
city: Tyler
country: United States
facility: Cardiovascular Associates of East Texas PA
state: Texas
city: Ogden
country: United States
facility: Utah Cardiology (Ogden UT)
state: Utah
city: Richmond
country: United States
facility: Virginia Cardiovascular Specialists PC
state: Virginia
city: Charleston
country: United States
facility: CAMC Institute Clinical Trials Center
state: West Virginia
city: Madison
country: United States
facility: Wisconsin Heart SC
state: Wisconsin
city: Wauwatosa
country: United States
facility: Arrhythmia Consultants of Milwaukee SC
state: Wisconsin
Study officials:
affiliation: Cardiovascular Division Brigham and Womens
name: Michael O. Sweeney
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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. doi: 10.1046/j.1540-8167.14.s9.14.x.
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. doi: 10.1056/NEJMoa043399.
citation: Liang KY, Zeger S. Longitudinal data analysis using generalized linear models. Biometrika, 1986, 73:13-22.