TRUST

TRUST

Efficacy and Safety of Automatic Remote Monitoring for Implantable Cardioverter-Defibrillator Follow-Up

Varma, Circulation 2012

Study Design

  • Multi-center, prospective, randomized study
  • Assesses that BIOTRONIK Home Monitoring can safely reduce in-office follow-ups
  • 1,450 patients enrolled at 102 centers in USA

Key Result 1

TRUST demonstrated equal safety event rate in both groups. BIOTRONIK Home Monitoring delivered a reduction of 45% of in-office follow-up visits.

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

Key Result 2

BIOTRONIK Home Monitoring delivered a significant gain in early detection of clinically relevant symptomatic and asymptomatic events

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Early detection- Asymptomatic and all arrhythmia event

Key Result 3

BIOTRONIK Home Monitoring significantly reduced the time to evaluation of clinically relevant tachyarrhythmia events

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Early detection of clinically relevant tacchyarrhythmia events

Clinical Relevance

  • The TRUST trial is the first and largest clinical study of its kind. It has clinically proven the safety and effectiveness of BIOTRONIK Home Monitoring
  • Results unequivocally establish BIOTRONIK Home Monitoring as a highly effective method of follow-up. Patients' safety is enhanced by enabling prompt medical care if problems occur in either their clinical condition or in their devices

Study Objective
  • The study aims to determine that BIOTRONIK Home Monitoring can safely reduce in-office follow-ups and provide early detection of VF, VT, SVT, and AF events
1 Endpoint
  • Effectiveness: to compare the number of in-office follow-ups between the BIOTRONIK Home Monitoring group and control group
  • Safety: to compare the composite safety event rate (SER): death, incidence of stroke, and events requiring surgical interventions between the two groups
2 Endpoint
  • To demonstrate that BIOTRONIK Home Monitoring provides early detection of VF, VT, SVT, and AF events and to demonstrate that BIOTRONIK Home Monitoring can be used to triage patient-initiated calls such as those following device therapy delivery, resulting in lower utilization of ER/clinic visits
  • Early detection: to compare the time from onset to evaluation of VF, VT, SVT and AF events between the two groups
  • Remote triage: to evaluate and compare between the two groups the number of patient initiated inquiries that result in emergency room (ER)/ clinic visits
Clinical Sites
  • 102 sites in USA
Sample Size
  • 1,450 patients enrolled
Inclusion Criteria
  • Implanted within 45 days prior to enrollment or being considered for implantation of a BIOTRONIK Lumax/ Lumos ICD with Home Monitoring technology
  • Ability to use HM system
  • Ability to give informed consent
  • Ability to return to clinic for protocol required follow-ups for 15 months
  • At least 18 years old
Main Exclusion Criteria
  • Patients who were pacemaker dependent when being considered for enrollment
  • Patients who were enrolled in any other cardiac clinical investigation when being considered for enrollment
  • Patients who did not fulfill all inclusion criteria
Devices
  • Patients were implanted with Lumax VR-T/DR-T or Lumos VR-T/DR-T
Study FlowchartFlow Chart Study Design TRUST
Study Duration
  • Patient participation and follow up period: up to 15 months
Reference no.
  • NCT00336284
Principal Investigators
  • Niraj Varma, M.D. (Principal Investigator, Cleveland Clinic, Cleveland, OH)
  • Andrew Epstein, M.D. (University of Pennsylvania, PA)
  • Venkateshwar Gottipaty, M.D. (South Carolina Heart, Columbia, SC)
  • Shumel Inbar, M.D. (Odessa, TX)
  • John Ip, M.D. (Ingham Hospital, Lansing, MI)
  • Charles Love, M.D. (Ohio State University, Columbus, OH)
  • Suresh Neelagaru, M.D. (Lone Star Arrhythmia & HF, Amarillo, TX)
  • Farrell Pierson, M.D.( Knoxville, TN) and Robert Schweikert, M.D. (Cleveland Clinic, Cleveland, OH

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