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Withings HFRN Retrospective Study

NCT07654491 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 9000

Last updated 2026-07-01

No results posted yet for this study

Summary

This is a fully decentralized retrospective, non-interventional study evaluating the diagnostic performance of the Withings Heart Function Risk Notification (HFRN), a software-only medical device (SaMD)

Conditions

Interventions

DEVICE

Withings Heart Function Risk Notification (HFRN)

Software-only medical device (SaMD)

OTHER

Claims-based heart-failure adjudication (reference standard)

Ground-truth heart-failure case / control status derived from administrative claims by a deterministic, pre-specified rule set.

Sponsors & Collaborators

  • Withings

    lead INDUSTRY

Principal Investigators

  • Pierre Escourrou, MD, PhD · Centre Interdisciplinaire du Sommeil, Paris, France

Eligibility

Min Age
45 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2026-09-30
Completion
2026-09-30
FDA Device
Yes

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 NCT07654491 on ClinicalTrials.gov