Heart Failure Management for Patient With CIED Remotely Monitored (PROACT-HF)

Implicity

Status: Not yet enrolling

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

Treatments: Device: SmartSignalHF; Device: HF RM standard of care

Study type: Interventional

Funder types: Industry

Identifiers

NCT07247032

2025-A01507-42

Details and patient eligibility

About

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.

Full description

SmartSignalHF is a novel digital health solution designed to support clinical decision-making by continuously analyzing Cardiac Implantable Electronic Devices (CIED) and patient data and providing actionable alerts to healthcare teams. By integrating this digital solution into the remote monitoring of HF patients, the study aims to enhance early detection of decompensation events and optimize therapeutic treatments.

Eligible patients implanted with an Implantable Cardioverter Defibrillator (ICD) or a Cardiac Resynchronization Therapy Defibrillator (CRT-D) and diagnosed with chronic heart failure will be randomized in a 1:1 ratio to either SmartSignalHF remote monitoring solution or standard HF remote monitoring solution.

The primary endpoint is a composite of all-cause mortality and HF hospitalizations within 12 months after randomization. Secondary endpoints include individual components of the primary endpoint, quality-of-life measures, and adherence to guideline-directed medical therapy (GDMT).

Enrollment: 1,132 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)
• Non-activation of others HF multisensor algorithms
• Patient remote monitored on Implicity CIED platform
• Patient with a documented diagnosis of heart failure, eligible to reimbursement in France or Germany for HF remote monitoring
• Patient is willing to be remotely monitored for heart failure
• HF treated according to European Society of Cardiology (ESC) guidelines

Exclusion criteria

• 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
• Patients already receiving remote monitoring for heart failure
• Pregnant or breastfeeding women
• Subjects under legal protection

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,132 participants in 2 patient groups

Standard remote monitoring

Active Comparator group

Description:

Standard remote monitoring of ICD or CRT-D and standard remote monitoring of heart failure

Treatment:

Device: HF RM standard of care

Remote monitoring with SmartSignalHF

Experimental group

Description:

Remote monitoring with the SmartSignalHF device

Treatment:

Device: SmartSignalHF