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

Biotronik

Status and phase: Completed; Phase 4

Conditions: Patient Indicated for an ICD

Treatments: Other: In-Office Conventional Follow-up; Other: Home Monitoring

Study type: Interventional

Funder types: Industry

Identifiers

NCT00336284

20052069

Details and patient eligibility

About

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.

Enrollment: 1,450 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,450 participants in 2 patient groups

Home Monitoring

Active Comparator group

Description:

Home Monitoring programmed on.

Treatment:

Other: Home Monitoring

In-Office Conventional Follow-up

Other group

Description:

Home Monitoring programmed off.

Treatment:

Other: In-Office Conventional Follow-up