Heart Failure Management for Patient With CIED Remotely Monitored

NCT07247032 | Recruiting DMC

• 1 other identifier: 2025-A01507-42
• Study Type: interventional
• Target: 1,132
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Composite measure of all-cause mortality and HF hospitalizations

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

Secondary Outcomes (15)

• 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

Study Arms (2)

Standard remote monitoring

ACTIVE COMPARATOR

Standard remote monitoring of ICD or CRT-D and standard remote monitoring of heart failure

Device: HF RM standard of care

Remote monitoring with SmartSignalHF

EXPERIMENTAL

Remote monitoring with the SmartSignalHF device

Device: SmartSignalHF

Interventions

SmartSignalHF DEVICE

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

Remote monitoring with SmartSignalHF

HF RM standard of care DEVICE

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

Standard remote monitoring

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Implicity: lead

Study Sites (1)

Implicity

Paris, 75002, France

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 25, 2025
• Study Start: December 19, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 31, 2026

Record last verified: 2025-12

Locations

FR (1)