NCT07247032

Heart Failure Management for Patient With CIED Remotely Monitored

Prospective Real World Heart Failure Management for Patient With CIED Remotely Monitored

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,132 (estimated)
• Sponsor: Implicity · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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).

Conditions

• Heart 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

Interventions

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

Timeline

• Start date: 2025-12-19
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2025-11-25
• Last updated: 2026-03-31

Locations

1 site across 1 country: France