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

Biotronik, Inc.1,450 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,450

Conditions

Patient Indicated for an ICD

Interventions

Home MonitoringOTHER

Home Monitoring programmed on. In-office and Home Monitoring evaluation at 3 and 15 months post ICD implant. Home Monitoring evaluation only at 6, 9, and 12 months post ICD implant.

In-Office Conventional Follow-upOTHER

Home Monitoring programmed off. In-office evaluations at 3, 6, 9, 12, and 15 months post ICD implant.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (110)

Outcomes

Primary Outcomes

Home Monitoring Effectiveness

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.

Time frame: 12 months

Percent of Participants Experiencing Death, Incidence of Stroke, or Event Requiring Surgical Intervention.

Percentage of participants experiencing death, incidence of stroke, or event(s) requiring surgical intervention. Outcome measure time frame is 12 months.

Time frame: 12 months

Secondary Outcomes

Early Detection of Cardiac Events

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

Time frame: 12 months

Patient Initiated Follow-up

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

Time frame: 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

...and 100 more locations