Clinical trial NCT00336284: TRUST: Lumos-T Safely RedUceS RouTine Office Device Follow-up
Official title: TRUST: Lumos-T Safely RedUceS RouTine Office Device Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Patient Indicated for an ICD
Keywords: Telemonitoring
ICD
Reduction of office follow-ups
Lead sponsor: Biotronik, Inc.
Sponsor class: INDUSTRY
First posted: 2006-06-13
Enrollment: 1450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Home Monitoring Effectiveness
timeFrame: 12 months
measure: Percent of Participants Experiencing Death, Incidence of Stroke, or Event Requiring Surgical Intervention.
timeFrame: 12 months
Secondary outcomes:
measure: Early Detection of Cardiac Events
timeFrame: 12 months
measure: Patient Initiated Follow-up
timeFrame: 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Site 55
state: Alabama
city: Mesa
country: United States
facility: Site 68
state: Arizona
city: Phoenix
country: United States
facility: Site 99
state: Arizona
city: Bakersfield
country: United States
facility: Site 118
state: California
city: Bakersfield
country: United States
facility: Site 91
state: California
city: Burbank
country: United States
facility: Site 95
state: California
city: Fairfield
country: United States
facility: Site 72
state: California
city: Fremont
country: United States
facility: Site 43
state: California
city: Fresno
country: United States
facility: Site 90
state: California
city: Fresno
country: United States
facility: Site 73
state: California
city: Fresno
country: United States
facility: Site 75
state: California
city: Glendale
country: United States
facility: Site 67
state: California
city: Jackson
country: United States
facility: Site 82
state: California
city: Mission Viejo
country: United States
facility: Site 78
state: California
city: Sherman Oaks
country: United States
facility: Site 15
state: California
city: Simi Valley
country: United States
facility: Site 89
state: California
city: Whittier
country: United States
facility: Site 88
state: California
city: Boulder
country: United States
facility: Site 37
state: Colorado
city: Boulder
country: United States
facility: Site 38
state: Colorado
city: Denver
country: United States
facility: Site 98
state: Colorado
city: Newark
country: United States
facility: Site 122
state: Delaware
city: Brooksville
country: United States
facility: Site 100
state: Florida
city: Jacksonville
country: United States
facility: Site 111
state: Florida
city: Lakeland
country: United States
facility: Site 40
state: Florida
city: Lauderdale Lakes
country: United States
facility: Site 36
state: Florida
city: Miami
country: United States
facility: Site 34
state: Florida
city: Oakland Park
country: United States
facility: Site 42
state: Florida
city: Port Charlotte
country: United States
facility: Site 13
state: Florida
city: Tamarac
country: United States
facility: Site 41
state: Florida
city: Vero Beach
country: United States
facility: Site 60
state: Florida
city: Canton
country: United States
facility: Site 6
state: Georgia
city: Douglas
country: United States
facility: Site 106
state: Georgia
city: Lawrenceville
country: United States
facility: Site 61
state: Georgia
city: Marietta
country: United States
facility: Site 10
state: Georgia
city: Marietta
country: United States
facility: Site 66
state: Georgia
city: Chicago
country: United States
facility: Site 21
state: Illinois
city: Chicago
country: United States
facility: Site 124
state: Illinois
city: Oak Lawn
country: United States
facility: Site 39
state: Illinois
city: Louisville
country: United States
facility: Site 3
state: Kentucky
city: Owensboro
country: United States
facility: Site 11
state: Kentucky
city: Covington
country: United States
facility: Site 51
state: Louisiana
city: Hammond
country: United States
facility: Site 79
state: Louisiana
city: Lacombe
country: United States
facility: Site 85
state: Louisiana
city: Lafayette
country: United States
facility: Site 102
state: Louisiana
city: Lake Charles
country: United States
facility: Site 2
state: Louisiana
city: New Orleans
country: United States
facility: Site 53
state: Louisiana
city: Annapolis
country: United States
facility: Site 17
state: Maryland
city: Lanham
country: United States
facility: Site 25
state: Maryland
city: Riverdale
country: United States
facility: Site 17
state: Maryland
city: Rockville
country: United States
facility: Site 18
state: Maryland
city: Boston
country: United States
facility: Site 29
state: Massachusetts
city: Ann Arbor
country: United States
facility: Site 94
state: Michigan
city: Bloomfield Hills
country: United States
facility: Site 103
state: Michigan
city: Lansing
country: United States
facility: Site 4
state: Michigan
city: Lapeer
country: United States
facility: Site 12
state: Michigan
city: Saginaw
country: United States
facility: Site 22
state: Michigan
city: Corinth
country: United States
facility: Site 14
state: Mississippi
city: Gulfport
country: United States
facility: Site 52
state: Mississippi
city: Bridgeton
country: United States
facility: Site 49
state: Missouri
city: Festus
country: United States
facility: Site 105
state: Missouri
city: Festus
country: United States
facility: Site 121
state: Missouri
city: Moberly
country: United States
facility: Site 45
state: Missouri
city: Osage Beach
country: United States
facility: Site 56
state: Missouri
city: St. Louis
country: United States
facility: Site 108
state: Missouri
city: St. Louis
country: United States
facility: Site 114
state: Missouri
city: St. Louis
country: United States
facility: Site 48
state: Missouri
city: St. Louis
country: United States
facility: Site 113
state: Missouri
city: St. Louis
country: United States
facility: Site 74
state: Missouri
city: University City
country: United States
facility: Site 47
state: Missouri
city: Brick
country: United States
facility: Site 117
state: New Jersey
city: East Brunswick
country: United States
facility: Site 120
state: New Jersey
city: East Orange
country: United States
facility: Site 107
state: New Jersey
city: Elizabeth
country: United States
facility: Site 119
state: New Jersey
city: Oakhurst
country: United States
facility: Site 116
state: New Jersey
city: Wayne
country: United States
facility: Site 71
state: New Jersey
city: Las Cruces
country: United States
facility: Site 97
state: New Mexico
city: Batavia
country: United States
facility: Site 112
state: New York
city: Brooklyn
country: United States
facility: Site 19
state: New York
city: Brooklyn
country: United States
facility: Site 27
state: New York
city: Brooklyn
country: United States
facility: Site 26
state: New York
city: Brooklyn
country: United States
facility: Site 77
state: New York
city: Johnson City
country: United States
facility: Site 9
state: New York
city: New York
country: United States
facility: Site 35
state: New York
city: New York
country: United States
facility: Site 76
state: New York
city: Pinehurst
country: United States
facility: Site 115
state: North Carolina
city: Cleveland
country: United States
facility: Site 57
state: Ohio
city: Columbus
country: United States
facility: Site 16
state: Ohio
city: Columbus
country: United States
facility: Site 50
state: Ohio
city: Fairview Park
country: United States
facility: Site 84
state: Ohio
city: Massillon
country: United States
facility: Site 93
state: Ohio
city: Middletown
country: United States
facility: Site 30
state: Ohio
city: Middletown
country: United States
facility: Site 87
state: Ohio
city: Tulsa
country: United States
facility: Site 96
state: Oklahoma
city: Chinchilla
country: United States
facility: Site 63
state: Pennsylvania
city: Clarks Summit
country: United States
facility: Site 62
state: Pennsylvania
city: Upland
country: United States
facility: Site 32
state: Pennsylvania
city: Columbia
country: United States
facility: Site 23
state: South Carolina
city: Florence
country: United States
facility: Site 20
state: South Carolina
city: Lancaster
country: United States
facility: Site 109
state: South Carolina
city: Rock Hill
country: United States
facility: Site 5
state: South Carolina
city: Knoxville
country: United States
facility: Site 59
state: Tennessee
city: Knoxville
country: United States
facility: Site 8
state: Tennessee
city: Tullahoma
country: United States
facility: Site 110
state: Tennessee
city: Amarillo
country: United States
facility: Site 1
state: Texas
city: Brownsville
country: United States
facility: Site 81
state: Texas
city: Odessa
country: United States
facility: Site 33
state: Texas
city: San Antonio
country: United States
facility: Site 80
state: Texas
city: Yakima
country: United States
facility: Site 7
state: Washington
city: Toronto
country: Canada
facility: Site 104
state: Ontario
city: Fleurimont
country: Canada
facility: Site 92
state: Quebec
Study officials:
affiliation: The Cleveland Clinic
name: Niraj Varma, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Varma 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.
citation: Varma 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.
citation: Varma 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.
citation: Varma 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.
citation: Varma 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.
citation: 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;3(5):428-36. doi: 10.1161/CIRCEP.110.951962. Epub 2010 Aug 17.