TRUST

TRUST

Lumos-T Safely Reduces Routine Office Device Follow-up

Demonstrate that the use of the BIOTRONIK Home Monitoring system can safely reduce the number of regularly scheduled office follow-up visits compared to the conventional method of ICD follow-up.

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Study Design

  • Prospective, randomized, multicenter
  • 1,339 subjects randomized 2:1 to HM or conventional follow-up at 102 centers

Study Design

Home Monitoring delivered a reduction of 45% of in-office follow-ups1

Grafic about mean number of in-office follow-up visits per patient /year

Clinical Relevance

BIOTRONIK Home Monitoring had the same safety event rate as the control group1

Early Detection

Home Monitoring detected arrhythmias 27-37 days (median) in advance of conventional office follow-up1

Early detection of clinically relevant tacchyarrhythmia events

Clinical Relevance

  • Home Monitoring safely reduced device follow-up burden
  • Home Monitoring provides early detection of clinically relevant events
  • Home Monitoring improves the efficiency of device patient office visits
Reference no.
  • NCT00336284
Study Objective
  • Demonstrate that the use of the BIOTRONIK Home Monitoring system can safely reduce the number of regularly scheduled office follow-up visits compared to the conventional method of ICD follow-up.
1° Endpoints
  • Compare number of office-based ICD follow-ups in HM group compared to conventional care.
  • Compare safety event rate between HM and conventional groups
2° Endpoints
  • Compare time to detection of symptomatic and asymptomatic cardiac events between HM and control groups
Clinical Sites
  • 102 US centers
Sample Size
  • 1,339 (2:1 randominization)
Inclusion Criteria
  • Implanted within 45 days or being considered for implant with a BIOTRONIK ICD with Home Monitoring
  • Able to utilize Home Monitoring throughout the study
  • Ability to give informed consent
  • Geographically stable and able to return for regular follow-up for 15 months
  • At least 18 years old
Main Exclusion Criteria
  • Patients who do not fulfill all inclusion criteria
  • Pacemaker dependent
  • Currently enrolled in any other cardiac clinical investigation
Devices
  • BIOTRONIK Lumos/Lumax DR/VR-T ICDs
Follow-Up
  • 15 Months post-implant
Study Duration
  • November 2005 - June 2009
Principal Investigators
  • Niraj Varma, Cleveland Clinic

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Clinical Relevance

1 Varma N, Epstein AE, Irimpen A, Schweikert R, Love C; TRUST Investigators. Efficacy and safety of automatic remote monitoring for implantable cardioverter-defibrillator follow-up: the Lumos-T Safely Reduces Routine Office Device Follow-up (TRUST) trial. Circulation. 2010 Jul 27;122(4):325-32. doi: 10.1161/CIRCULATIONAHA.110.937409. Epub 2010 Jul 12.

3 Varma N, Pavri BB, Stambler B, Michalski J; TRUST Investigators. Same-day discovery of implantable cardioverter defibrillator dysfunction in the TRUST remote monitoring trial: influence of contrasting messaging systems. Europace. 2013 May;15(5):697-703. doi: 10.1093/europace/eus410. Epub 2012 Dec 19.

Clinical Relevance

2 Varma N, Michalski J, Stambler B, Pavri BB; TRUST Investigators. Superiority of automatic remote monitoring compared with in-person evaluation for scheduled ICD follow-up in the TRUST trial - testing execution of the recommendations. Eur Heart J. 2014 May 21;35(20):1345-52. doi: 10.1093/eurheartj/ehu066. Epub 2014 Mar 3.

4 Varma N, Michalski J, Epstein AE, Schweikert R. Automatic remote monitoring of implantable cardioverter-defibrillator lead and generator performance: the Lumos-T Safely RedUceS RouTine Office Device Follow-Up (TRUST) trial. Circ Arrhythm Electrophysiol. 2010 Oct;3(5):428-36. doi: 10.1161/CIRCEP.110.951962. Epub 2010 Aug 17.