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Patient Indicated for an ICDPhase 4TRUSTNCT00336284

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

A Phase 4 study testing Home Monitoring and In-Office Conventional Follow-up in people with Patient Indicated for an ICD, run by Biotronik, Inc. at 110 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Patient Indicated for an ICD
What is being tested?
Home Monitoring and In-Office Conventional Follow-up
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,450 participants
Where
110 sitesin 2 countries
Study dates
Nov 2005to Jun 2009
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

110 sites in 2 countries.

110 sites in 2 countries

United States108 sites

  • Site 1

    Amarillo, Texas, 79106

  • Site 94

    Ann Arbor, Michigan, 48109-0273

  • Site 17

    Annapolis, Maryland, 21401

  • Site 118

    Bakersfield, California, 93301

  • Site 91

    Bakersfield, California, 93301

  • Site 112

    Batavia, New York, 14020

  • Site 55

    Birmingham, Alabama, 35294

  • Site 103

    Bloomfield Hills, Michigan, 48302

  • Site 29

    Boston, Massachusetts, 02135

  • Site 37

    Boulder, Colorado, 80304

  • Site 38

    Boulder, Colorado, 80304

  • Site 117

    Brick, New Jersey, 08724

  • Site 49

    Bridgeton, Missouri, 63044

  • Site 19

    Brooklyn, New York, 11203

  • Site 27

    Brooklyn, New York, 11203

  • Site 26

    Brooklyn, New York, 11209

  • Site 77

    Brooklyn, New York, 11223

  • Site 100

    Brooksville, Florida, 34613

  • Site 81

    Brownsville, Texas, 78520

  • Site 95

    Burbank, California, 91505

  • Site 6

    Canton, Georgia, 30114

  • Site 21

    Chicago, Illinois, 60153

  • Site 124

    Chicago, Illinois, 60657

  • Site 63

    Chinchilla, Pennsylvania, 18410

  • Site 62

    Clarks Summit, Pennsylvania, 18411

  • Site 57

    Cleveland, Ohio, 44195

  • Site 23

    Columbia, South Carolina, 29204

  • Site 16

    Columbus, Ohio, 43210

  • Site 50

    Columbus, Ohio, 43228

  • Site 14

    Corinth, Mississippi, 38834

  • Site 51

    Covington, Louisiana, 70433

  • Site 98

    Denver, Colorado, 80210

  • Site 106

    Douglas, Georgia, 31533

  • Site 120

    East Brunswick, New Jersey, 08816

  • Site 107

    East Orange, New Jersey, 07019

  • Site 119

    Elizabeth, New Jersey, 07202

  • Site 72

    Fairfield, California, 94533

  • Site 84

    Fairview Park, Ohio, 44129

  • Site 105

    Festus, Missouri, 63028

  • Site 121

    Festus, Missouri, 63028

  • Site 20

    Florence, South Carolina, 29506

  • Site 43

    Fremont, California, 94568

  • Site 90

    Fresno, California, 93701

  • Site 73

    Fresno, California, 93720

  • Site 75

    Fresno, California, 93720

  • Site 67

    Glendale, California, 91203

  • Site 52

    Gulfport, Mississippi, 39503

  • Site 79

    Hammond, Louisiana, 70403

  • Site 82

    Jackson, California, 95642

  • Site 111

    Jacksonville, Florida, 32207

  • Site 9

    Johnson City, New York, 13790

  • Site 59

    Knoxville, Tennessee, 37923

  • Site 8

    Knoxville, Tennessee, 37923

  • Site 85

    Lacombe, Louisiana, 70445

  • Site 102

    Lafayette, Louisiana, 70503

  • Site 2

    Lake Charles, Louisiana, 70601

  • Site 40

    Lakeland, Florida, 33803

  • Site 109

    Lancaster, South Carolina, 29720

  • Site 25

    Lanham, Maryland, 20706

  • Site 4

    Lansing, Michigan, 48910

  • Site 12

    Lapeer, Michigan, 48446

  • Site 97

    Las Cruces, New Mexico, 88011

  • Site 36

    Lauderdale Lakes, Florida, 33313

  • Site 61

    Lawrenceville, Georgia, 30045

  • Site 3

    Louisville, Kentucky, 40215

  • Site 10

    Marietta, Georgia, 30060

  • Site 66

    Marietta, Georgia, 30060

  • Site 93

    Massillon, Ohio, 44646

  • Site 68

    Mesa, Arizona, 85205

  • Site 34

    Miami, Florida, 33176

  • Site 30

    Middletown, Ohio, 45042

  • Site 87

    Middletown, Ohio, 45042

  • Site 78

    Mission Viejo, California, 92691

  • Site 45

    Moberly, Missouri, 65270

  • Site 53

    New Orleans, Louisiana, 70112

  • Site 35

    New York, New York, 10021

  • Site 76

    New York, New York, 10028

  • Site 122

    Newark, Delaware, 19713

  • Site 39

    Oak Lawn, Illinois, 60453

  • Site 116

    Oakhurst, New Jersey, 07755

  • Site 42

    Oakland Park, Florida, 33334

  • Site 33

    Odessa, Texas, 79761

  • Site 56

    Osage Beach, Missouri, 65065

  • Site 11

    Owensboro, Kentucky, 42303

  • Site 99

    Phoenix, Arizona, 85016

  • Site 115

    Pinehurst, North Carolina, 28374

  • Site 13

    Port Charlotte, Florida, 33952

  • Site 17

    Riverdale, Maryland, 20737

  • Site 5

    Rock Hill, South Carolina, 29732

  • Site 18

    Rockville, Maryland, 20852

  • Site 22

    Saginaw, Michigan, 48601

  • Site 80

    San Antonio, Texas, 78229

  • Site 15

    Sherman Oaks, California, 91403

  • Site 89

    Simi Valley, California, 93065

  • Site 108

    St Louis, Missouri, 63103

  • Site 114

    St Louis, Missouri, 63117

  • Site 48

    St Louis, Missouri, 63128

  • Site 113

    St Louis, Missouri, 63131

  • Site 74

    St Louis, Missouri, 63131

  • Site 41

    Tamarac, Florida, 33321

  • Site 110

    Tullahoma, Tennessee, 37388

  • Site 96

    Tulsa, Oklahoma, 74136

  • Site 47

    University City, Missouri, 63130

  • Site 32

    Upland, Pennsylvania, 19013

  • Site 60

    Vero Beach, Florida, 32960

  • Site 71

    Wayne, New Jersey, 07470

  • Site 88

    Whittier, California, 90603

  • Site 7

    Yakima, Washington, 98902

Other trials in United States

Canada2 sites

  • Site 92

    Fleurimont, Quebec

  • Site 104

    Toronto, Ontario

Other trials in Canada

About this study

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.

Being tested
Home Monitoring, In-Office Conventional Follow-up
Keywords
Telemonitoring, ICD, Reduction of office follow-ups

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Home MonitoringOther

    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-upOther

    Home Monitoring programmed off. In-office evaluations at 3, 6, 9, 12, and 15 months post ICD implant.

Study groups in NCT00336284
Study groupRoleWhat they receive
Home MonitoringActive comparatorHome Monitoring programmed on.
Receives: Other: Home Monitoring
In-Office Conventional Follow-upOtherHome Monitoring programmed off.
Receives: Other: In-Office Conventional Follow-up

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months

  2. 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.

    Measured: 12 months

Secondary outcomes (2)

  1. Early Detection of Cardiac Events

    Detection time relative to onset of cardiac events (atrial fibrillation, ventricular tachycardia, ventricular fibrillation).

    Measured: 12 months

  2. Patient Initiated Follow-up

    Percentage of total patient initiated inqueries that result in ER or office follow-up visits.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2006 (estimated)
  2. Study startNov 2005
  3. Primary completionJun 2009
  4. Study completionJun 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,450 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00336284
Sponsor's protocol ID
20052069
Acronym
TRUST
Status last verified
Jul 2010
First submitted
9 Jun 2006
Last updated
3 Aug 2010
Data monitoring committee
No

Publications

  • 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.

    PubMed 20625110

  • Chew 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.

    PubMed 36503177

  • 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.

    PubMed 33640345

  • 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.

    PubMed 29016878

  • 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.

    PubMed 26661687

  • 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.

    PubMed 24595864

  • 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.

    PubMed 23258817

  • 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.

    PubMed 20716717

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Home Monitoring and In-Office Conventional Follow-up in people with Patient Indicated for an ICD, run by Biotronik, Inc. at 110 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 110 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Mar 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Home Monitoring Effectiveness (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00336284, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2010.

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