TRUST: Lumos-T Safely RedUceS RouTine Office Device Follow-up

This study has been completed.

Sponsor:

Information provided by:

Biotronik, Inc.

ClinicalTrials.gov Identifier:

NCT00336284

First received: June 9, 2006

Last updated: July 28, 2010

Last verified: July 2010

History of Changes

Purpose

This study is a multi-center, prospective and randomized trial. The primary objective of this study is to demonstrate that the use of the BIOTRONIK Home Monitoring system (HM) can safely reduce the number of regularly scheduled office follow-up visits, compared to the conventional method of implantable cardioverter defibrillator (ICD) follow-up.

Condition	Intervention	Phase
Patient Indicated for an ICD	Other: Home Monitoring Other: In-Office Conventional Follow-up	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	TRUST: Lumos-T Safely RedUceS RouTine Office Device Follow-up

Further study details as provided by Biotronik, Inc.:

Primary Outcome Measures:

Home Monitoring Effectiveness [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Average number of office-based implantable cardioverter defibrillator (ICD) follow-up visits in the Home Monitoring arm vs the Conventional (calendar-based) follow-up arm.
Percent of Participants Experiencing Death, Incidence of Stroke, or Event Requiring Surgical Intervention. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Percentage of participants experiencing death, incidence of stroke, or event(s) requiring surgical intervention. Outcome measure time frame is 12 months.

Secondary Outcome Measures:

Early Detection of Cardiac Events [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Detection time relative to onset of cardiac events (atrial fibrillation, ventricular tachycardia, ventricular fibrillation).
Patient Initiated Follow-up [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Percentage of total patient initiated inqueries that result in ER or office follow-up visits.

Enrollment:	1450
Study Start Date:	November 2005
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Home Monitoring Home Monitoring programmed on.	Other: Home Monitoring Home Monitoring programmed on. In-office and Home Monitoring evaluation at 3 and 15 months post ICD implant. Home Monitoring evaluation only at 6, 9, and 12 months post ICD implant.
In-Office Conventional Follow-up Home Monitoring programmed off.	Other: In-Office Conventional Follow-up Home Monitoring programmed off. In-office evaluations at 3, 6, 9, 12, and 15 months post ICD implant.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Implanted within the last 45 days or being considered for implant with a BIOTRONIK ICD with Home Monitoring (HM)/Intracardiac Electrogram (IEGM)-Online technology, or legally marketed future generation device with HM/IEGM Online.
Able to utilize the HM system throughout the study
Ability to give informed consent
Geographically stable and able to return for regular follow-ups for fifteen (15) months
At least 18 years old

Exclusion Criteria:

Patients who do not fulfill all inclusion criteria
Pacemaker dependent
Currently enrolled in any other cardiac clinical investigation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00336284

Hide Study Locations

Locations

United States, Alabama
Site 55
Birmingham, Alabama, United States, 35294
United States, Arizona
Site 68
Mesa, Arizona, United States, 85205
Site 99
Phoenix, Arizona, United States, 85016
United States, California
Site 118
Bakersfield, California, United States, 93301
Site 91
Bakersfield, California, United States, 93301
Site 95
Burbank, California, United States, 91505
Site 72
Fairfield, California, United States, 94533
Site 43
Fremont, California, United States, 94568
Site 73
Fresno, California, United States, 93720
Site 75
Fresno, California, United States, 93720
Site 90
Fresno, California, United States, 93701
Site 67
Glendale, California, United States, 91203
Site 82
Jackson, California, United States, 95642
Site 78
Mission Viejo, California, United States, 92691
Site 15
Sherman Oaks, California, United States, 91403
Site 89
Simi Valley, California, United States, 93065
Site 88
Whittier, California, United States, 90603
United States, Colorado
Site 37
Boulder, Colorado, United States, 80304
Site 38
Boulder, Colorado, United States, 80304
Site 98
Denver, Colorado, United States, 80210
United States, Delaware
Site 122
Newark, Delaware, United States, 19713
United States, Florida
Site 100
Brooksville, Florida, United States, 34613
Site 111
Jacksonville, Florida, United States, 32207
Site 40
Lakeland, Florida, United States, 33803
Site 36
Lauderdale Lakes, Florida, United States, 33313
Site 34
Miami, Florida, United States, 33176
Site 42
Oakland Park, Florida, United States, 33334
Site 13
Port Charlotte, Florida, United States, 33952
Site 41
Tamarac, Florida, United States, 33321
Site 60
Vero Beach, Florida, United States, 32960
United States, Georgia
Site 6
Canton, Georgia, United States, 30114
Site 106
Douglas, Georgia, United States, 31533
Site 61
Lawrenceville, Georgia, United States, 30045
Site 10
Marietta, Georgia, United States, 30060
Site 66
Marietta, Georgia, United States, 30060
United States, Illinois
Site 21
Chicago, Illinois, United States, 60153
Site 124
Chicago, Illinois, United States, 60657
Site 39
Oak Lawn, Illinois, United States, 60453
United States, Kentucky
Site 3
Louisville, Kentucky, United States, 40215
Site 11
Owensboro, Kentucky, United States, 42303
United States, Louisiana
Site 51
Covington, Louisiana, United States, 70433
Site 79
Hammond, Louisiana, United States, 70403
Site 85
Lacombe, Louisiana, United States, 70445
Site 102
Lafayette, Louisiana, United States, 70503
Site 2
Lake Charles, Louisiana, United States, 70601
Site 53
New Orleans, Louisiana, United States, 70112
United States, Maryland
Site 17
Annapolis, Maryland, United States, 21401
Site 25
Lanham, Maryland, United States, 20706
Site 17
Riverdale, Maryland, United States, 20737
Site 18
Rockville, Maryland, United States, 20852
United States, Massachusetts
Site 29
Boston, Massachusetts, United States, 02135
United States, Michigan
Site 94
Ann Arbor, Michigan, United States, 48109-0273
Site 103
Bloomfield Hills, Michigan, United States, 48302
Site 4
Lansing, Michigan, United States, 48910
Site 12
Lapeer, Michigan, United States, 48446
Site 22
Saginaw, Michigan, United States, 48601
United States, Mississippi
Site 14
Corinth, Mississippi, United States, 38834
Site 52
Gulfport, Mississippi, United States, 39503
United States, Missouri
Site 49
Bridgeton, Missouri, United States, 63044
Site 121
Festus, Missouri, United States, 63028
Site 105
Festus, Missouri, United States, 63028
Site 45
Moberly, Missouri, United States, 65270
Site 56
Osage Beach, Missouri, United States, 65065
Site 108
St. Louis, Missouri, United States, 63103
Site 48
St. Louis, Missouri, United States, 63128
Site 74
St. Louis, Missouri, United States, 63131
Site 113
St. Louis, Missouri, United States, 63131
Site 114
St. Louis, Missouri, United States, 63117
Site 47
University City, Missouri, United States, 63130
United States, New Jersey
Site 117
Brick, New Jersey, United States, 08724
Site 120
East Brunswick, New Jersey, United States, 08816
Site 107
East Orange, New Jersey, United States, 07019
Site 119
Elizabeth, New Jersey, United States, 07202
Site 116
Oakhurst, New Jersey, United States, 07755
Site 71
Wayne, New Jersey, United States, 07470
United States, New Mexico
Site 97
Las Cruces, New Mexico, United States, 88011
United States, New York
Site 112
Batavia, New York, United States, 14020
Site 27
Brooklyn, New York, United States, 11203
Site 77
Brooklyn, New York, United States, 11223
Site 19
Brooklyn, New York, United States, 11203
Site 26
Brooklyn, New York, United States, 11209
Site 9
Johnson City, New York, United States, 13790
Site 35
New York, New York, United States, 10021
Site 76
New York, New York, United States, 10028
United States, North Carolina
Site 115
Pinehurst, North Carolina, United States, 28374
United States, Ohio
Site 57
Cleveland, Ohio, United States, 44195
Site 16
Columbus, Ohio, United States, 43210
Site 50
Columbus, Ohio, United States, 43228
Site 84
Fairview Park, Ohio, United States, 44129
Site 93
Massillon, Ohio, United States, 44646
Site 30
Middletown, Ohio, United States, 45042
Site 87
Middletown, Ohio, United States, 45042
United States, Oklahoma
Site 96
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
Site 63
Chinchilla, Pennsylvania, United States, 18410
Site 62
Clarks Summit, Pennsylvania, United States, 18411
Site 32
Upland, Pennsylvania, United States, 19013
United States, South Carolina
Site 23
Columbia, South Carolina, United States, 29204
Site 20
Florence, South Carolina, United States, 29506
Site 109
Lancaster, South Carolina, United States, 29720
Site 5
Rock Hill, South Carolina, United States, 29732
United States, Tennessee
Site 8
Knoxville, Tennessee, United States, 37923
Site 59
Knoxville, Tennessee, United States, 37923
Site 110
Tullahoma, Tennessee, United States, 37388
United States, Texas
Site 1
Amarillo, Texas, United States, 79106
Site 81
Brownsville, Texas, United States, 78520
Site 33
Odessa, Texas, United States, 79761
Site 80
San Antonio, Texas, United States, 78229
United States, Washington
Site 7
Yakima, Washington, United States, 98902
Canada, Ontario
Site 104
Toronto, Ontario, Canada
Canada, Quebec
Site 92
Fleurimont, Quebec, Canada

Sponsors and Collaborators

Biotronik, Inc.

Investigators

Principal Investigator:

Niraj Varma, MD, FRCP

The Cleveland Clinic

More Information

Publications:

Varma N, Epstein AE, Irimpen A, Schweikert R, Love C; for the TRUST Investigators. Efficacy and Safety of Automatic Remote Monitoring for Implantable Cardioverter-Defibrillator Follow-Up: The Lumos-T Safely Reduces Routine Office Device Follow-Up (TRUST) Trial. Circulation. 2010 Jul 27;122(4):325-332. Epub 2010 Jul 12.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Varma N, Michalski J, Epstein AE, Schweikert R. Automatic remote monitoring of implantable cardioverter-defibrillator lead and generator performance: the Lumos-T Safely RedUceS RouTine Office Device Follow-Up (TRUST) trial. Circ Arrhythm Electrophysiol. 2010 Oct 1;3(5):428-36. Epub 2010 Aug 17.

Responsible Party:	Justin Michalski, M.S. / Clinical Studies Engineer, BIOTRONIK, Inc.
ClinicalTrials.gov Identifier:	NCT00336284 History of Changes
Other Study ID Numbers:	20052069
Study First Received:	June 9, 2006
Results First Received:	January 12, 2010
Last Updated:	July 28, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Biotronik, Inc.:

Telemonitoring
ICD
Reduction of office follow-ups

ClinicalTrials.gov processed this record on May 22, 2013

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