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. 2017 May 10;38(22):1749–1755. doi: 10.1093/eurheartj/ehx015

Table1.

Included trials

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
a

Denmark (three sites), Czech Republic (two), Israel (two), Australia (one), Austria (one), Latvia (one).

b

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.