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

Study Overview
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Brief Summary
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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.

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

Conditions
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Patient Indicated for an ICD

Intervention / Treatment
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* Other: Home Monitoring
* Other: In-Office Conventional Follow-up


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Home Monitoring<br>Home Monitoring programmed on. | Other: Home Monitoring<br>* 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.<br>|
| Other: In-Office Conventional Follow-up<br>Home Monitoring programmed off. | Other: In-Office Conventional Follow-up<br>* Home Monitoring programmed off. In-office evaluations at 3, 6, 9, 12, and 15 months post ICD implant.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early Detection of Cardiac Events | Detection time relative to onset of cardiac events (atrial fibrillation, ventricular tachycardia, ventricular fibrillation). | 12 months | 
| Patient Initiated Follow-up | Percentage of total patient initiated inqueries that result in ER or office follow-up visits. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telemonitoring, ICD, Reduction of office follow-ups