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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Heart Failure NYHA Class II; Heart Failure NYHA Class III; CRT and/or ICD; Heart Failure With Reduced Ejection Fraction (HFrEF); Heart Failure With Decompensation
• Intervention / Treatment: Device: HF RM standard of care; Device: SmartSignalHF

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).

• Study Type: Interventional
• Enrollment (Estimated): 1132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75002
    • Recruiting
    • Implicity
    • Contact: Arnaud Rosier, MD; Phone Number: +33(0) 7 43 39 91 48; Email: contact@implicity.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard remote monitoring; Standard remote monitoring of ICD or CRT-D and standard remote monitoring of heart failure	Device: HF RM standard of care; HF RM standard of care defined in the country (France or Germany)
Experimental: Remote monitoring with SmartSignalHF; Remote monitoring with the SmartSignalHF device	Device: SmartSignalHF; SmartSignalHF; a solution aiming to predict episodes of cardiac decompensation in patients implanted with an ICD or CRT-D

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Composite measure of all-cause mortality and HF hospitalizations	From enrollment to the end of follow-up at 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality		From enrollment to the end of follow-up at 12 months
HF mortality		From enrollment to the end of follow-up at 12 months
HF hospitalizations		From enrollment to the end of follow-up at 12 months
HF readmissions		From enrollment to the end of follow-up at 12 months
HF outpatient visits		From enrollment to the end of follow-up at 12 months
All cause hospitalizations		From enrollment to the end of follow-up at 12 months
HF hospitalization duration		From enrollment to the end of follow-up at 12 months
Proportion of patients without contraindications receiving 4- drug GDMT		At 12 months
Proportion of patients achieving ≥ 50% target doses or maximum tolerated doses for each drug class		At 12 months
Proportion of patients achieving 100% target doses or maximum tolerated doses for each drug class		At 12 months
Rate of patients who completed the study follow-up		At 12 months
Rate of premature study discontinuation due to withdrawal of consent for remote monitoring		From enrollment to the end of follow-up at 12 months
Data completion rate		At 12 months
Adverse events linked to the device during the follow-up		From enrollment to the end of follow-up at 12 months
Minnesota Living with Heart Failure Questionnaire (MLHFQ) total score	The Minnesota Living With Heart Failure Questionnaire (MLHFQ) total score ranges from a minimum of 0 (best possible health-related quality of life) to a maximum of 105 (worst possible health-related quality of life).	At baseline and at 12 months

Collaborators and Investigators

• Sponsor: Implicity

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: November 19, 2025
• First Posted (Actual): November 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: 2025-A01507-42

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No