MedTrace Logo

Heart Failure Management for Patient With CIED Remotely Monitored

NCT07247032 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1132

Last updated 2026-03-31

No results posted yet for this study

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
  • Heart Failure With Reduced Ejection Fraction (HFrEF)
  • Heart Failure With Decompensation
  • CRT and/or ICD

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)

Sponsors & Collaborators

  • Implicity

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-19
Primary Completion
2027-05-31
Completion
2027-05-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07247032 on ClinicalTrials.gov