Table1.
TRUST3 | ECOST5 | IN-TIME12 | |
---|---|---|---|
No. of centres | 102 USA sites | 43 French sites | 26 German sites, 10 sites elsewherea |
Patient eligibility | Class1 indication for ICD, not pacemaker dependent | Indication for ICD, not NYHA class IV | Indication for ICD or CRT-D, heart failure (≥ 3 months), NYHA class II or III, LVEF ≤ 35% |
Primary objective | To evaluate safety and efficacy of extended IO intervals | To compare major CVAEs including all-cause death | To compare heart failure outcomes using composite (“Packer”) scoreb |
Follow-up schedule | |||
HM group | IO at 3M and 15M. HM replaced IO at 6M, 9M, and 12M | IO at 1-3M, 15M, and 27M. HM replaced IO at 9M and 21M | IO at 12M, and in-between according to hospital routine |
Control group | IO every 3M | IO at 1-3M, then every 6M | Same as in the HM group |
Blinded endpoint committee | No | Yes | Yes |
Denmark (three sites), Czech Republic (two), Israel (two), Australia (one), Austria (one), Latvia (one).
The score combines all-cause death, overnight hospitalization for heart failure, change in NYHA class, and change in patient global self-assessment.
CRT-D, cardiac resynchronization therapy defibrillator; CVAE, cardiovascular adverse event; ECOST, Effectiveness and cost of ICDs follow-up schedule with telecardiology; HM, Home Monitoring; ICD, implantable cardioverter-defibrillator; IN-TIME, Influence of HM on mortality and morbidity in heart failure patients with impaired left ventricular function; IO, in-office visit; LVEF, left ventricular ejection fraction; M, months; NYHA, New York Heart Association; TRUST, Lumos-T safely reduces routine office device follow-up.