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RECRUITING
NCT07247032
NA

Heart Failure Management for Patient With CIED Remotely Monitored

Sponsor: Implicity

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

1132

Start Date

2025-12-19

Completion Date

2027-05

Last Updated

2026-03-31

Healthy Volunteers

No

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)

Locations (1)

Implicity

Paris, France