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

This study has been completed.
Sponsor:
Information provided by:
Biotronik, Inc.
ClinicalTrials.gov Identifier:
NCT00336284
First received: June 9, 2006
Last updated: July 28, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Patient Indicated for an ICD
Other: Home Monitoring
Other: In-Office Conventional Follow-up
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: TRUST: Lumos-T Safely RedUceS RouTine Office Device Follow-up

Resource links provided by NLM:


Further study details as provided by Biotronik, Inc.:

Primary Outcome Measures:
  • Home Monitoring Effectiveness [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Percentage of participants experiencing death, incidence of stroke, or event(s) requiring surgical intervention. Outcome measure time frame is 12 months.


Secondary Outcome Measures:
  • Early Detection of Cardiac Events [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Detection time relative to onset of cardiac events (atrial fibrillation, ventricular tachycardia, ventricular fibrillation).

  • Patient Initiated Follow-up [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Percentage of total patient initiated inqueries that result in ER or office follow-up visits.


Enrollment: 1450
Study Start Date: November 2005
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Home Monitoring
Home Monitoring programmed on.
Other: Home Monitoring
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
Home Monitoring programmed off.
Other: In-Office Conventional Follow-up
Home Monitoring programmed off. In-office evaluations at 3, 6, 9, 12, and 15 months post ICD implant.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00336284

  Show 110 Study Locations
Sponsors and Collaborators
Biotronik, Inc.
Investigators
Principal Investigator: Niraj Varma, MD, FRCP The Cleveland Clinic
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Justin Michalski, M.S. / Clinical Studies Engineer, BIOTRONIK, Inc.
ClinicalTrials.gov Identifier: NCT00336284     History of Changes
Other Study ID Numbers: 20052069
Study First Received: June 9, 2006
Results First Received: January 12, 2010
Last Updated: July 28, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Biotronik, Inc.:
Telemonitoring
ICD
Reduction of office follow-ups

ClinicalTrials.gov processed this record on August 28, 2014