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

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2006-06-09
• Study First Submitted QC: 2006-06-09
• Study First Posted: 2006-06-13
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Results First Submitted: 2010-01-12
• Results First Submitted QC: 2010-03-16
• Results First Posted: 2010-03-30
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-28
• Last Update Posted: 2010-08-03

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

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

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