TRUST: Lumos-T Safely RedUceS RouTine Office Device Follow-up
- 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
- 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
- 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
Name Time Method 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.
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
Name Time Method Early Detection of Cardiac Events 12 months Detection time relative to onset of cardiac events (atrial fibrillation, ventricular tachycardia, ventricular fibrillation).
Patient Initiated Follow-up 12 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