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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00336284
Recruitment Status : Completed
First Posted : June 13, 2006
Results First Posted : March 30, 2010
Last Update Posted : August 3, 2010
Sponsor:
Information provided by:
Biotronik, Inc.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Patient Indicated for an ICD Other: Home Monitoring Other: In-Office Conventional Follow-up Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TRUST: Lumos-T Safely RedUceS RouTine Office Device Follow-up
Study Start Date : November 2005
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009
Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00336284


Locations
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Sponsors and Collaborators
Biotronik, Inc.
Investigators
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Principal Investigator: Niraj Varma, MD, FRCP The Cleveland Clinic
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Justin Michalski, M.S. / Clinical Studies Engineer, BIOTRONIK, Inc.
ClinicalTrials.gov Identifier: NCT00336284    
Other Study ID Numbers: 20052069
First Posted: June 13, 2006    Key Record Dates
Results First Posted: March 30, 2010
Last Update Posted: August 3, 2010
Last Verified: July 2010
Keywords provided by Biotronik, Inc.:
Telemonitoring
ICD
Reduction of office follow-ups