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

Sponsored by:	Biotronik, Inc.
Information provided by:	Biotronik, Inc.
ClinicalTrials.gov Identifier:	NCT00336284

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	Device: ICD with Telemonitoring	Phase IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	TRUST: Lumos-T Safely RedUceS RouTine Office Device Follow-up

Further study details as provided by Biotronik, Inc.:

Primary Outcome Measures:

Compare the number of ICD follow-ups for patients with Home Monitoring to patients with the conventional, calendar-based ICD follow-up method [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Compare the Safety Event Rate (includes death, incidence of strokes and events requiring surgical interventions)between the two groups [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Compare cardiac events (AF, VT, VF) between the two groups in terms of the number, categories, and detection time relative to onset [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Evaluate and compare between groups the number of patient initiated inquiries that result in ER or office device interrogations [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment:	1516
Study Start Date:	October 2005
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Home Monitoring follow-ups compared to conventional office visit follow-ups of ICDs

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/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

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

Loyola University

More Information

Responsible Party:	BIOTRONIK, Inc. ( Lori Gibson, D.V.M. )
Study ID Numbers:	20052069
Study First Received:	June 9, 2006
Last Updated:	March 5, 2008
ClinicalTrials.gov Identifier:	NCT00336284
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 January 16, 2009