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Recruiting NCT07247032

Heart Failure Management for Patient With CIED Remotely Monitored

No phase Interventional Heart Failure Heart Failure NYHA Class II Heart Failure NYHA Class III Heart Failure With Reduced Ejection Fraction (HFrEF)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SmartSignalHF, HF RM standard of care.
Who it may be relevant to
Registry conditions: Heart Failure, Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure With Reduced Ejection Fraction (HFrEF). Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • 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)

Primary outcome measures

  • Composite measure of all-cause mortality and HF hospitalizations [Time frame: From enrollment to the end of follow-up at 12 months]
Secondary outcome measures (12)
  • All-cause mortality [Time frame: From enrollment to the end of follow-up at 12 months]
  • HF mortality [Time frame: From enrollment to the end of follow-up at 12 months]
  • HF hospitalizations [Time frame: From enrollment to the end of follow-up at 12 months]
  • HF readmissions [Time frame: From enrollment to the end of follow-up at 12 months]
  • HF outpatient visits [Time frame: From enrollment to the end of follow-up at 12 months]
  • All cause hospitalizations [Time frame: From enrollment to the end of follow-up at 12 months]
  • HF hospitalization duration [Time frame: From enrollment to the end of follow-up at 12 months]
  • Proportion of patients without contraindications receiving 4- drug GDMT [Time frame: At 12 months]
  • Proportion of patients achieving ≥ 50% target doses or maximum tolerated doses for each drug class [Time frame: At 12 months]
  • Proportion of patients achieving 100% target doses or maximum tolerated doses for each drug class [Time frame: At 12 months]
  • Minnesota Living with Heart Failure Questionnaire (MLHFQ) total score [Time frame: At baseline and at 12 months]
  • Rate of patients who completed the study follow-up [Time frame: At 12 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

France · 1 center
  • Implicity — Paris

Identifiers

NCT: NCT07247032 · 2025-A01507-42

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗