The MOnitoring Resynchronization dEvices and CARdiac patiEnts (MORE-CARE) Randomized Controlled Trial: Phase 1 Results on Dynamics of Early Intervention With Remote Monitoring

154 patients with moderate to severe heart failure (NYHA class III/IV, LVEF <35%) in sinus rhythm with de novo implantation of CRT-D, mean age ~67, ~73% male, multinational (6 countries).

Remote monitoring (RM) with CareLink network including wireless automatic alerts for lung fluid (OptiVol), atrial tachyarrhythmia, and device integrity, with in-office visits at baseline and 8 months, and remote follow-ups at 4 and 12 months.

Standard follow-up without automatic alerts (in-office visits at baseline and every 4 months). Audible alerts for device integrity/VF detection off were activated in both groups.

Delay between an alert event and clinical decisions related to the event in the first 154 enrolled patients followed for 1 year.