Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07654491

Withings HFRN Retrospective Study

Sponsor: Withings

View on ClinicalTrials.gov

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)

Official title: Validation of the Withings Heart Function Risk Notification (HFRN)

Key Details

Gender

All

Age Range

45 Years - 120 Years

Study Type

OBSERVATIONAL

Enrollment

9000

Start Date

2026-06

Completion Date

2026-09

Last Updated

2026-07-01

Healthy Volunteers

Yes

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.

Locations (1)

Withings (Sponsor) - Decentralized Retrospective Study, No Physical Sites

Issy-les-Moulineaux, Île-de-France Region, France