TRUST: Lumos-T Safely RedUceS RouTine Office Device Follow-up
TRUST
1 other identifier
interventional
1,450
2 countries
110
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2005
Longer than P75 for phase_4
110 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
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 9, 2006
CompletedFirst Posted
Study publicly available on registry
June 13, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedResults Posted
Study results publicly available
March 30, 2010
CompletedAugust 3, 2010
July 1, 2010
3.6 years
June 9, 2006
January 12, 2010
July 28, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Home Monitoring Effectiveness
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.
12 months
Percent of Participants Experiencing Death, Incidence of Stroke, or Event Requiring Surgical Intervention.
Percentage of participants experiencing death, incidence of stroke, or event(s) requiring surgical intervention. Outcome measure time frame is 12 months.
12 months
Secondary Outcomes (2)
Early Detection of Cardiac Events
12 months
Patient Initiated Follow-up
12 months
Study Arms (2)
Home Monitoring
ACTIVE COMPARATORHome Monitoring programmed on.
In-Office Conventional Follow-up
OTHERHome Monitoring programmed off.
Interventions
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.
Home Monitoring programmed off. In-office evaluations at 3, 6, 9, 12, and 15 months post ICD implant.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pacemaker dependent
- Currently enrolled in any other cardiac clinical investigation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biotronik, Inc.lead
Study Sites (110)
Site 55
Birmingham, Alabama, 35294, United States
Site 68
Mesa, Arizona, 85205, United States
Site 99
Phoenix, Arizona, 85016, United States
Site 118
Bakersfield, California, 93301, United States
Site 91
Bakersfield, California, 93301, United States
Site 95
Burbank, California, 91505, United States
Site 72
Fairfield, California, 94533, United States
Site 43
Fremont, California, 94568, United States
Site 90
Fresno, California, 93701, United States
Site 73
Fresno, California, 93720, United States
Site 75
Fresno, California, 93720, United States
Site 67
Glendale, California, 91203, United States
Site 82
Jackson, California, 95642, United States
Site 78
Mission Viejo, California, 92691, United States
Site 15
Sherman Oaks, California, 91403, United States
Site 89
Simi Valley, California, 93065, United States
Site 88
Whittier, California, 90603, United States
Site 37
Boulder, Colorado, 80304, United States
Site 38
Boulder, Colorado, 80304, United States
Site 98
Denver, Colorado, 80210, United States
Site 122
Newark, Delaware, 19713, United States
Site 100
Brooksville, Florida, 34613, United States
Site 111
Jacksonville, Florida, 32207, United States
Site 40
Lakeland, Florida, 33803, United States
Site 36
Lauderdale Lakes, Florida, 33313, United States
Site 34
Miami, Florida, 33176, United States
Site 42
Oakland Park, Florida, 33334, United States
Site 13
Port Charlotte, Florida, 33952, United States
Site 41
Tamarac, Florida, 33321, United States
Site 60
Vero Beach, Florida, 32960, United States
Site 6
Canton, Georgia, 30114, United States
Site 106
Douglas, Georgia, 31533, United States
Site 61
Lawrenceville, Georgia, 30045, United States
Site 10
Marietta, Georgia, 30060, United States
Site 66
Marietta, Georgia, 30060, United States
Site 21
Chicago, Illinois, 60153, United States
Site 124
Chicago, Illinois, 60657, United States
Site 39
Oak Lawn, Illinois, 60453, United States
Site 3
Louisville, Kentucky, 40215, United States
Site 11
Owensboro, Kentucky, 42303, United States
Site 51
Covington, Louisiana, 70433, United States
Site 79
Hammond, Louisiana, 70403, United States
Site 85
Lacombe, Louisiana, 70445, United States
Site 102
Lafayette, Louisiana, 70503, United States
Site 2
Lake Charles, Louisiana, 70601, United States
Site 53
New Orleans, Louisiana, 70112, United States
Site 17
Annapolis, Maryland, 21401, United States
Site 25
Lanham, Maryland, 20706, United States
Site 17
Riverdale, Maryland, 20737, United States
Site 18
Rockville, Maryland, 20852, United States
Site 29
Boston, Massachusetts, 02135, United States
Site 94
Ann Arbor, Michigan, 48109-0273, United States
Site 103
Bloomfield Hills, Michigan, 48302, United States
Site 4
Lansing, Michigan, 48910, United States
Site 12
Lapeer, Michigan, 48446, United States
Site 22
Saginaw, Michigan, 48601, United States
Site 14
Corinth, Mississippi, 38834, United States
Site 52
Gulfport, Mississippi, 39503, United States
Site 49
Bridgeton, Missouri, 63044, United States
Site 105
Festus, Missouri, 63028, United States
Site 121
Festus, Missouri, 63028, United States
Site 45
Moberly, Missouri, 65270, United States
Site 56
Osage Beach, Missouri, 65065, United States
Site 108
St Louis, Missouri, 63103, United States
Site 114
St Louis, Missouri, 63117, United States
Site 48
St Louis, Missouri, 63128, United States
Site 113
St Louis, Missouri, 63131, United States
Site 74
St Louis, Missouri, 63131, United States
Site 47
University City, Missouri, 63130, United States
Site 117
Brick, New Jersey, 08724, United States
Site 120
East Brunswick, New Jersey, 08816, United States
Site 107
East Orange, New Jersey, 07019, United States
Site 119
Elizabeth, New Jersey, 07202, United States
Site 116
Oakhurst, New Jersey, 07755, United States
Site 71
Wayne, New Jersey, 07470, United States
Site 97
Las Cruces, New Mexico, 88011, United States
Site 112
Batavia, New York, 14020, United States
Site 19
Brooklyn, New York, 11203, United States
Site 27
Brooklyn, New York, 11203, United States
Site 26
Brooklyn, New York, 11209, United States
Site 77
Brooklyn, New York, 11223, United States
Site 9
Johnson City, New York, 13790, United States
Site 35
New York, New York, 10021, United States
Site 76
New York, New York, 10028, United States
Site 115
Pinehurst, North Carolina, 28374, United States
Site 57
Cleveland, Ohio, 44195, United States
Site 16
Columbus, Ohio, 43210, United States
Site 50
Columbus, Ohio, 43228, United States
Site 84
Fairview Park, Ohio, 44129, United States
Site 93
Massillon, Ohio, 44646, United States
Site 30
Middletown, Ohio, 45042, United States
Site 87
Middletown, Ohio, 45042, United States
Site 96
Tulsa, Oklahoma, 74136, United States
Site 63
Chinchilla, Pennsylvania, 18410, United States
Site 62
Clarks Summit, Pennsylvania, 18411, United States
Site 32
Upland, Pennsylvania, 19013, United States
Site 23
Columbia, South Carolina, 29204, United States
Site 20
Florence, South Carolina, 29506, United States
Site 109
Lancaster, South Carolina, 29720, United States
Site 5
Rock Hill, South Carolina, 29732, United States
Site 59
Knoxville, Tennessee, 37923, United States
Site 8
Knoxville, Tennessee, 37923, United States
Site 110
Tullahoma, Tennessee, 37388, United States
Site 1
Amarillo, Texas, 79106, United States
Site 81
Brownsville, Texas, 78520, United States
Site 33
Odessa, Texas, 79761, United States
Site 80
San Antonio, Texas, 78229, United States
Site 7
Yakima, Washington, 98902, United States
Site 104
Toronto, Ontario, Canada
Site 92
Fleurimont, Quebec, Canada
Related Publications (8)
Varma N, Epstein AE, Irimpen A, Schweikert R, Love C; 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):325-32. doi: 10.1161/CIRCULATIONAHA.110.937409. Epub 2010 Jul 12.
PMID: 20625110RESULTChew DS, Piccini JP, Au F, Frazier-Mills CG, Michalski J, Varma N; TRUST Investigators. Alert-driven vs scheduled remote monitoring of implantable cardiac defibrillators: A cost-consequence analysis from the TRUST trial. Heart Rhythm. 2023 Mar;20(3):440-447. doi: 10.1016/j.hrthm.2022.12.003. Epub 2022 Dec 8.
PMID: 36503177DERIVEDVarma N, Love CJ, Michalski J, Epstein AE; TRUST Investigators. Alert-Based ICD Follow-Up: A Model of Digitally Driven Remote Patient Monitoring. JACC Clin Electrophysiol. 2021 Aug;7(8):976-987. doi: 10.1016/j.jacep.2021.01.008. Epub 2021 Feb 24.
PMID: 33640345DERIVEDVarma N, Love CJ, Schweikert R, Moll P, Michalski J, Epstein AE; TRUST Investigators. Automatic remote monitoring utilizing daily transmissions: transmission reliability and implantable cardioverter defibrillator battery longevity in the TRUST trial. Europace. 2018 Apr 1;20(4):622-628. doi: 10.1093/europace/eux059.
PMID: 29016878DERIVEDVarma N, Epstein AE, Schweikert R, Michalski J, Love CJ; TRUST Investigators. Role of Automatic Wireless Remote Monitoring Immediately Following ICD Implant: The Lumos-T Reduces Routine Office Device Follow-Up Study (TRUST) Trial. J Cardiovasc Electrophysiol. 2016 Mar;27(3):321-6. doi: 10.1111/jce.12895. Epub 2016 Jan 27.
PMID: 26661687DERIVEDVarma N, Michalski J, Stambler B, Pavri BB; TRUST Investigators. Superiority of automatic remote monitoring compared with in-person evaluation for scheduled ICD follow-up in the TRUST trial - testing execution of the recommendations. Eur Heart J. 2014 May 21;35(20):1345-52. doi: 10.1093/eurheartj/ehu066. Epub 2014 Mar 3.
PMID: 24595864DERIVEDVarma N, Pavri BB, Stambler B, Michalski J; TRUST Investigators. Same-day discovery of implantable cardioverter defibrillator dysfunction in the TRUST remote monitoring trial: influence of contrasting messaging systems. Europace. 2013 May;15(5):697-703. doi: 10.1093/europace/eus410. Epub 2012 Dec 19.
PMID: 23258817DERIVEDVarma 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;3(5):428-36. doi: 10.1161/CIRCEP.110.951962. Epub 2010 Aug 17.
PMID: 20716717DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Justin Michalski, M.S. / Clinical Studies Engineer
- Organization
- Biotronik, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Niraj Varma, MD, FRCP
The Cleveland Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 9, 2006
First Posted
June 13, 2006
Study Start
November 1, 2005
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
August 3, 2010
Results First Posted
March 30, 2010
Record last verified: 2010-07