TRUST Clinical Trial

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

Primary 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

Major Secondary Endpoints

• 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

Main 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