NCT07247032 Heart Failure Management for Patient With CIED Remotely Monitored
| NCT ID | NCT07247032 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Implicity |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,132 participants |
| Start Date | 2025-12-19 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,132 participants in total. It began in 2025-12-19 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Frequently Asked Questions
Who can join the NCT07247032 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07247032 currently recruiting?
Yes, NCT07247032 is actively recruiting participants. Visit ClinicalTrials.gov or contact Implicity to inquire about joining.
Where is the NCT07247032 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT07247032 clinical trial?
NCT07247032 is sponsored by Implicity. The trial plans to enroll 1,132 participants.
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