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OpenTrials
Completed

NCT Number: NCT00336284

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

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.

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Key information

Conditions

Patient Indicated for an ICD

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Site 104, Toronto, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home Monitoring

Other

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-up

Other

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

Primary outcomes

  1. Home Monitoring Effectiveness

    Time frame: 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.

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

    Time frame: 12 months

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

Secondary outcomes

  1. Early Detection of Cardiac Events

    Time frame: 12 months

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

  2. Patient Initiated Follow-up

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Biotronik, Inc.

Industry

Registry information

Acronym: TRUST

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Jun 13, 2006
Registry last updated
Aug 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.