Phase 4
Completed N=1,450
TRUST: Lumos-T Safely RedUceS RouTine Office Device Follow-up
Patient Indicated for an ICD
Source: ClinicalTrials.gov NCT00336284 ↗
Enrolled (actual)
1,450
Serious AEs
13.7%
Results posted
Mar 2010
Primary outcomePrimary: Home Monitoring Effectiveness — 2.1; 3.8 In-office ICD follow-up per patient year — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Home Monitoring Effectiveness |
2.1; 3.8 | <0.001 sig |
| PRIMARY Percent of Participants Experiencing Death, Incidence of Stroke, or Event Requiring Surgical Intervention. |
10.4; 10.4 | 0.005 sig |
| SECONDARY Early Detection of Cardiac Events |
13.98; 45.34 | 0.016 sig |
| SECONDARY Patient Initiated Follow-up |
92.7; 100 | — |
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
Data sourced from ClinicalTrials.gov (NCT00336284). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.