Heart Failure Management for Patient With CIED Remotely Monitored

NCT ID: NCT07247032

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2027-05-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Standard remote monitoring

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

Group Type: ACTIVE_COMPARATOR

HF RM standard of care

Intervention Type: DEVICE

HF RM standard of care defined in the country (France or Germany)

Remote monitoring with SmartSignalHF

Remote monitoring with the SmartSignalHF device

Group Type: EXPERIMENTAL

SmartSignalHF

Intervention Type: DEVICE

SmartSignalHF; a solution aiming to predict episodes of cardiac decompensation in patients implanted with an ICD or CRT-D

Interventions

SmartSignalHF

SmartSignalHF; a solution aiming to predict episodes of cardiac decompensation in patients implanted with an ICD or CRT-D

Intervention Type: DEVICE

HF RM standard of care

HF RM standard of care defined in the country (France or Germany)

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Implicity

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2025-A01507-42

Identifier Type: -

Identifier Source: org_study_id