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NCT Number: NCT07247032

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.

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Key information

Conditions

Heart Failure CRT and/or ICD Cardiovascular Diseases Heart Diseases Heart Failure NYHA Class II Heart Failure NYHA Class III Heart Failure With Decompensation Heart Failure With Reduced Ejection Fraction (HFrEF)

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SmartSignalHF

Device

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

HF RM standard of care

Device

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

Primary outcomes

  1. Composite measure of all-cause mortality and HF hospitalizations

    Time frame: From enrollment to the end of follow-up at 12 months

Secondary outcomes

  1. All-cause mortality

    Time frame: From enrollment to the end of follow-up at 12 months

  2. HF mortality

    Time frame: From enrollment to the end of follow-up at 12 months

  3. HF hospitalizations

    Time frame: From enrollment to the end of follow-up at 12 months

  4. HF readmissions

    Time frame: From enrollment to the end of follow-up at 12 months

  5. HF outpatient visits

    Time frame: From enrollment to the end of follow-up at 12 months

  6. All cause hospitalizations

    Time frame: From enrollment to the end of follow-up at 12 months

  7. HF hospitalization duration

    Time frame: From enrollment to the end of follow-up at 12 months

  8. Proportion of patients without contraindications receiving 4- drug GDMT

    Time frame: At 12 months

  9. Proportion of patients achieving ≥ 50% target doses or maximum tolerated doses for each drug class

    Time frame: At 12 months

  10. Proportion of patients achieving 100% target doses or maximum tolerated doses for each drug class

    Time frame: At 12 months

  11. Minnesota Living with Heart Failure Questionnaire (MLHFQ) total score

    Time frame: At baseline and at 12 months

    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).

  12. Rate of patients who completed the study follow-up

    Time frame: At 12 months

  13. Rate of premature study discontinuation due to withdrawal of consent for remote monitoring

    Time frame: From enrollment to the end of follow-up at 12 months

  14. Data completion rate

    Time frame: At 12 months

  15. Adverse events linked to the device during the follow-up

    Time frame: From enrollment to the end of follow-up at 12 months

Sponsors and collaborators

Lead sponsor

Implicity

Industry

Registry information

Official study title

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

Acronym: PROACT-HF

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 25, 2025
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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