MedPath

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

Phase 4
Completed
Conditions
Patient Indicated for an ICD
Registration Number
NCT00336284
Lead Sponsor
Biotronik, Inc.
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1450
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Home Monitoring Effectiveness12 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.

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 Outcome Measures
NameTimeMethod
Early Detection of Cardiac Events12 months

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

Patient Initiated Follow-up12 months

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

Trial Locations

Locations (109)

Site 55

🇺🇸

Birmingham, Alabama, United States

Site 68

🇺🇸

Mesa, Arizona, United States

Site 99

🇺🇸

Phoenix, Arizona, United States

Site 118

🇺🇸

Bakersfield, California, United States

Site 91

🇺🇸

Bakersfield, California, United States

Site 95

🇺🇸

Burbank, California, United States

Site 72

🇺🇸

Fairfield, California, United States

Site 43

🇺🇸

Fremont, California, United States

Site 90

🇺🇸

Fresno, California, United States

Site 73

🇺🇸

Fresno, California, United States

Scroll for more (99 remaining)
Site 55
🇺🇸Birmingham, Alabama, United States

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