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

Phase 4

Completed

Conditions: Patient Indicated for an ICD

Interventions: Other: In-Office Conventional Follow-up
Other: Home Monitoring

Registration Number: NCT00336284

Lead Sponsor: Biotronik, Inc.

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1450

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
In-Office Conventional Follow-up	In-Office Conventional Follow-up	Home Monitoring programmed off.
Home Monitoring	Home Monitoring	Home Monitoring programmed on.

Primary Outcome Measures

Name	Time	Method
Home Monitoring Effectiveness	12 months	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.	12 months	Percentage of participants experiencing death, incidence of stroke, or event(s) requiring surgical intervention. Outcome measure time frame is 12 months.

Secondary Outcome Measures

Name	Time	Method
Early Detection of Cardiac Events	12 months	Detection time relative to onset of cardiac events (atrial fibrillation, ventricular tachycardia, ventricular fibrillation).
Patient Initiated Follow-up	12 months	Percentage of total patient initiated inqueries that result in ER or office follow-up visits.

Trial Locations

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