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.

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

Early detection- Asymptomatic and all arrhythmia event

Key Result 3

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

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 Flowchart
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