Trial · NCT00336284
TRUST: Lumos-T Safely RedUceS RouTine Office Device Follow-up
NCT00336284, Phase 4, Completed, Biotronik, Inc.; results first posted 2010-03-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. TRUST: Lumos-T Safely RedUceS RouTine Office Device Follow-up. Trials, record NCT00336284. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00336284
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- TRUST: Lumos-T Safely RedUceS RouTine Office Device Follow-up
- NCT number
- NCT00336284
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,450 participants, actual
- Lead sponsor
- Biotronik, Inc.
- Conditions
- Patient Indicated for an ICD
- Interventions
- Home Monitoring, In-Office Conventional Follow-up
- First posted
- 2006-06-13
- Last updated
- 2010-08-03
- Results first posted
- 2010-03-30
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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 | Early Detection of Cardiac Events | 12 months | Detection time relative to onset of cardiac events (atrial fibrillation, ventricular tachycardia, ventricular fibrillation). |
| Secondary | Patient Initiated Follow-up | 12 months | Percentage of total patient initiated inqueries that result in ER or office follow-up visits. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Home Monitoring Effectiveness | 12 months | Only participants who completed at least one follow-up visit are included in the analyses. | In-office ICD follow-up per patient year | MEAN |
| PRIMARY | Percent of Participants Experiencing Death, Incidence of Stroke, or Event Requiring Surgical Intervention. | 12 months | Safety Event Rate includes events occuring within 12 months of enrollment for participants with at least 1 follow-up. | Percentage of participants | NUMBER |
| SECONDARY | Early Detection of Cardiac Events | 12 months | Only participants with at least one follow-up are included in the analyses. | Days | MEAN |
| SECONDARY | Patient Initiated Follow-up | 12 months | Only participants with at least one follow-up are included in the analyses | percent of patient initiated follow-ups | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Home Monitoring Effectiveness | Home Monitoring | 2.1 | Full Range 0 to 45.6 | In-office ICD follow-up per patient year | |
| Home Monitoring Effectiveness | Conventional | 3.8 | Full Range 0 to 19.2 | In-office ICD follow-up per patient year | |
| Percent of Participants Experiencing Death, Incidence of Stroke, or Event Requiring Surgical Intervention. | Home Monitoring | 10.4 | Percentage of participants | ||
| Percent of Participants Experiencing Death, Incidence of Stroke, or Event Requiring Surgical Intervention. | Conventional | 10.4 | Percentage of participants | ||
| Early Detection of Cardiac Events | Home Monitoring | 13.98 | Full Range 0 to 256 | Days | |
| Early Detection of Cardiac Events | Conventional | 45.34 | Full Range 0 to 287 | Days | |
| Patient Initiated Follow-up | Home Monitoring | 92.7 | percent of patient initiated follow-ups | ||
| Patient Initiated Follow-up | Conventional | 100 | percent of patient initiated follow-ups |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Home Monitoring | 977 | |
| Overall Study | STARTED | Conventional | 473 | |
| Overall Study | COMPLETED | Home Monitoring | 741 | |
| Overall Study | COMPLETED | Conventional | 322 | |
| Overall Study | NOT COMPLETED | Home Monitoring | 236 | |
| Overall Study | NOT COMPLETED | Conventional | 151 |
Source ClinicalTrials.gov
Adverse events32
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Ablation procedure | Surgical and medical procedures | Home Monitoring | 5 | 977 | 5 |
| serious | Ablation procedure | Surgical and medical procedures | Conventional | 4 | 473 | 4 |
| serious | Aborted upgrade procedure | Surgical and medical procedures | Home Monitoring | 0 | 977 | 0 |
| serious | Aborted upgrade procedure | Surgical and medical procedures | Conventional | 1 | 473 | 1 |
| serious | Cardiac related hospitalizations | Cardiac disorders | Home Monitoring | 45 | 977 | 64 |
| serious | Cardiac related hospitalizations | Cardiac disorders | Conventional | 31 | 473 | 35 |
| serious | Catheterization/PCI procedure | Surgical and medical procedures | Home Monitoring | 15 | 977 | 16 |
| serious | Catheterization/PCI procedure | Surgical and medical procedures | Conventional | 3 | 473 | 4 |
| serious | Coronary artery bypass graft procedure | Surgical and medical procedures | Home Monitoring | 3 | 977 | 3 |
| serious | Coronary artery bypass graft procedure | Surgical and medical procedures | Conventional | 0 | 473 | 0 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Home Monitoring | ||
| Total, all-cause mortality | Conventional | ||
| Total, other adverse events | Home Monitoring | 0 | 977 |
| Total, other adverse events | Conventional | 0 | 473 |
| Total, serious adverse events | Home Monitoring | 124 | 977 |
| Total, serious adverse events | Conventional | 74 | 473 |
Source ClinicalTrials.gov
Papers8
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Home Monitoring vs Conventional: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00336284
GET https://conductscience.org/api/trials/v1/NCT00336284/events?page=2