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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00336284
Acronym
TRUST
Enrollment
1450
Registered
2006-06-13
Start date
2005-11-30
Completion date
2009-06-30
Last updated
2010-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient Indicated for an ICD

Keywords

Telemonitoring, ICD, Reduction of office follow-ups

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.

Interventions

OTHERHome 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.

OTHERIn-Office Conventional Follow-up

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

Sponsors

Biotronik, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Home Monitoring Effectiveness12 monthsAverage 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 monthsPercentage of participants experiencing death, incidence of stroke, or event(s) requiring surgical intervention. Outcome measure time frame is 12 months.

Secondary

MeasureTime frameDescription
Early Detection of Cardiac Events12 monthsDetection time relative to onset of cardiac events (atrial fibrillation, ventricular tachycardia, ventricular fibrillation).
Patient Initiated Follow-up12 monthsPercentage of total patient initiated inqueries that result in ER or office follow-up visits.

Countries

Canada, United States

Participant flow

Participants by arm

ArmCount
Home Monitoring
Home Monitoring programmed ON
908
Conventional
Home Monitoring programmed OFF
431
Total1,339

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath5226
Overall StudyLost to Follow-up8261
Overall StudyWithdrawal by Physician or Subject10264

Baseline characteristics

CharacteristicHome MonitoringConventionalTotal
Age Continuous63 years
STANDARD_DEVIATION 13
64 years
STANDARD_DEVIATION 12
64 years
STANDARD_DEVIATION 13
Region of Enrollment
Canada
12 participants6 participants18 participants
Region of Enrollment
United States
896 participants425 participants1321 participants
Sex: Female, Male
Female
254 Participants116 Participants370 Participants
Sex: Female, Male
Male
654 Participants315 Participants969 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 9770 / 473
serious
Total, serious adverse events
124 / 97774 / 473

Outcome results

Primary

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.

Time frame: 12 months

Population: Only participants who completed at least one follow-up visit are included in the analyses.

ArmMeasureValue (MEAN)
Home MonitoringHome Monitoring Effectiveness2.1 In-office ICD follow-up per patient year
ConventionalHome Monitoring Effectiveness3.8 In-office ICD follow-up per patient year
p-value: <0.001t-test, 2 sided
Primary

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.

Time frame: 12 months

Population: Safety Event Rate includes events occuring within 12 months of enrollment for participants with at least 1 follow-up.

ArmMeasureValue (NUMBER)
Home MonitoringPercent of Participants Experiencing Death, Incidence of Stroke, or Event Requiring Surgical Intervention.10.4 Percentage of participants
ConventionalPercent of Participants Experiencing Death, Incidence of Stroke, or Event Requiring Surgical Intervention.10.4 Percentage of participants
p-value: 0.005Exact binomial test for non-inferiority
Secondary

Early Detection of Cardiac Events

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

Time frame: 12 months

Population: Only participants with at least one follow-up are included in the analyses.

ArmMeasureValue (MEAN)
Home MonitoringEarly Detection of Cardiac Events13.98 Days
ConventionalEarly Detection of Cardiac Events45.34 Days
p-value: 0.016t-test, 2 sided
Secondary

Patient Initiated Follow-up

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

Time frame: 12 months

Population: Only participants with at least one follow-up are included in the analyses

ArmMeasureValue (NUMBER)
Home MonitoringPatient Initiated Follow-up92.7 percent of patient initiated follow-ups
ConventionalPatient Initiated Follow-up100 percent of patient initiated follow-ups

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026