Heart Failure Management for Patient With CIED Remotely Monitored

ConditionsHeart Failure Heart Failure NYHA Class II Heart Failure NYHA Class III Heart Failure With Reduced Ejection Fraction (HFrEF)Heart Failure With Decompensation CRT and/or ICD

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-85

SponsorImplicity

About this trial

This randomized, controlled, open-label, parallel, multicenter clinical study evaluates the efficacy of SmartSignalHF compared with heart failure (HF) remote monitoring (RM) standard of care in implanted patients with heart failure. The primary objective is to determine whether SmartSignalHF reduces all-cause mortality and HF hospitalizations at 12 months.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient aged 18-85

Patient diagnosed with a New York Heart Association (NYHA) class II or III

Patients with left ventricular ejection fraction ≼ 40 %

Patient implanted with an ICD or CRT-D (BiV and/or LBBA pacing) since at least 30 days and compatible with SignalHF (Biotronik, Boston Scientific and Medtronic)

Disqualifiers

Patients undergoing or awaiting heart transplant or left ventricular assist device (LVAD) procedures

Patients with a life expectancy of less than 12 months

Patients enrolled in concurrent clinical studies

Patients with a history of non-compliance with medical care or inability to comply with the study protocol

Trial design

Design model

Parallel

Treatments tested in this trial

SmartSignalHF
Device
SmartSignalHF; a solution aiming to predict episodes of cardiac decompensation in patients implanted with an ICD or CRT-D
HF RM standard of care
Device
HF RM standard of care defined in the country (France or Germany)

Treatment groups

1,132 Participants

are divided into 2 treatment groups

Group A: Standard remote monitoringActive comparator 1 intervention

Group B: Remote monitoring with SmartSignalHFExperimental treatment 1 intervention