Heart FailurePROACT-HFNCT07247032
Heart Failure Management for Patient With CIED Remotely Monitored
A study testing SmartSignalHF in people with Heart Failure and Heart Failure NYHA Class II, run by Implicity at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Failure, Heart Failure NYHA Class II, Heart Failure NYHA Class III
- What is being tested?
- SmartSignalHF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,132 participants
- Where
- 1 siteFrance
- Study dates
- 19 Dec 2025to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Implicity
Paris, 75002
Arnaud Rosier, MD, +33(0) 7 43 39 91 48, contact@implicity.com
About this study
Official title: 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.
Read the 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
- Being tested
- SmartSignalHF, HF RM standard of care
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartSignalHFDevice
SmartSignalHF; a solution aiming to predict episodes of cardiac decompensation in patients implanted with an ICD or CRT-D
HF RM standard of careDevice
HF RM standard of care defined in the country (France or Germany)
| Study group | Role | What they receive |
|---|---|---|
| Standard remote monitoring | Active comparator | Standard remote monitoring of ICD or CRT-D and standard remote monitoring of heart failure Receives: Device: HF RM standard of care |
| Remote monitoring with SmartSignalHF | Experimental | Remote monitoring with the SmartSignalHF device Receives: Device: SmartSignalHF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite measure of all-cause mortality and HF hospitalizations
Measured: From enrollment to the end of follow-up at 12 months
Secondary outcomes (15)
All-cause mortality
Measured: From enrollment to the end of follow-up at 12 months
HF mortality
Measured: From enrollment to the end of follow-up at 12 months
HF hospitalizations
Measured: From enrollment to the end of follow-up at 12 months
HF readmissions
Measured: From enrollment to the end of follow-up at 12 months
HF outpatient visits
Measured: From enrollment to the end of follow-up at 12 months
All cause hospitalizations
Measured: From enrollment to the end of follow-up at 12 months
HF hospitalization duration
Measured: From enrollment to the end of follow-up at 12 months
Proportion of patients without contraindications receiving 4- drug GDMT
Measured: At 12 months
Proportion of patients achieving ≥ 50% target doses or maximum tolerated doses for each drug class
Measured: At 12 months
Proportion of patients achieving 100% target doses or maximum tolerated doses for each drug class
Measured: 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).
Measured: At baseline and at 12 months
Rate of patients who completed the study follow-up
Measured: At 12 months
Rate of premature study discontinuation due to withdrawal of consent for remote monitoring
Measured: From enrollment to the end of follow-up at 12 months
Data completion rate
Measured: At 12 months
Adverse events linked to the device during the follow-up
Measured: From enrollment to the end of follow-up at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start19 Dec 2025
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Implicity
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07247032
- Sponsor's protocol ID
- 2025-A01507-42
- Acronym
- PROACT-HF
- Status last verified
- Dec 2025
- First submitted
- 19 Nov 2025
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Real World Heart Failure Management for Patient With CIED Remotely Monitored
- ClinicalTrials.gov ID
- NCT07247032
- Acronym / sponsor ID
- PROACT-HF / 2025-A01507-42
- 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 type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,132 participants (estimated)
- Lead sponsor
- ImplicityIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard remote monitoring | Active comparator | Device: HF RM standard of careStandard remote monitoring of ICD or CRT-D and standard remote monitoring of heart failure |
| Remote monitoring with SmartSignalHF | Experimental | Device: SmartSignalHFRemote monitoring with the SmartSignalHF device |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SmartSignalHFSmartSignalHF; a solution aiming to predict episodes of cardiac decompensation in patients implanted with an ICD or CRT-D | Device | Remote monitoring with SmartSignalHF |
| HF RM standard of careHF RM standard of care defined in the country (France or Germany) | Device | Standard remote monitoring |
Primary outcome
Composite measure of all-cause mortality and HF hospitalizations
Time frame: From enrollment to the end of follow-up at 12 months
15 secondary outcomes
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
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
Data completion rate
Time frame: At 12 months
Adverse events linked to the device during the follow-up
Time frame: From enrollment to the end of follow-up at 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SmartSignalHF in people with Heart Failure and Heart Failure NYHA Class II, run by Implicity at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite measure of all-cause mortality and HF hospitalizations (time frame: From enrollment to the end of follow-up at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.