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RecruitingNot ApplicableNCT07247032

Heart Failure Management for Patient With CIED Remotely Monitored

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

Sponsor

Implicity

Enrollment

1,132 participants

Start Date

Dec 19, 2025

Study Type

INTERVENTIONAL

Conditions

Heart FailureHeart Failure With Reduced Ejection Fraction (HFrEF)Heart Failure NYHA Class IIIHeart Failure; With DecompensationHeart Failure NYHA Class IICRT and/or ICD

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

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called HF RM standard of care and a medical device called SmartSignalHF for people with crt and/or icd, heart failure, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 85 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESmartSignalHF

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

DEVICEHF RM standard of care

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

Locations(1)

Implicity

Paris, France

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NCT07247032

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