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

July 28, 2010 updated by: Biotronik, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1450

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Home Monitoring Effectiveness
Time Frame: 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.
12 months
Percent of Participants Experiencing Death, Incidence of Stroke, or Event Requiring Surgical Intervention.
Time Frame: 12 months
Percentage of participants experiencing death, incidence of stroke, or event(s) requiring surgical intervention. Outcome measure time frame is 12 months.
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotronik, Inc.

Investigators

  • Principal Investigator: Niraj Varma, MD, FRCP, The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

June 9, 2006

First Submitted That Met QC Criteria

June 9, 2006

First Posted (Estimate)

June 13, 2006

Study Record Updates

Last Update Posted (Estimate)

August 3, 2010

Last Update Submitted That Met QC Criteria

July 28, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20052069

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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