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NOT YET RECRUITING
NCT07654491

Withings Heart Function Risk Notification 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) that analyzes longitudinal weight / BMI, body-water-percent variability, and activity (step) data collected passively by Withings connected smart scales and the Withings activity-tracking ecosystem. The study estimates Sensitivity (Se) and Specificity (Sp) of HFRN against a US claims-based (HealthVerity) heart-failure reference standard, evaluated on a pre-specified holdout test set. The findings support a 510(k) substantial-equivalence determination to the predicate Viz HCM (DEN230003) within the Cardiovascular machine learning-based notification software generic type (21 CFR 870.2380).

Official title: Validation of the Withings Heart Function Risk Notification (HFRN): A Retrospective Study of Diagnostic Performance for Heart Failure Detection in US Consumer Smart-Scale Users

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

2026-06-17

Healthy Volunteers

Yes

Conditions

Interventions

DEVICE

Withings Heart Function Risk Notification (HFRN)

Software-only medical device (SaMD): an algorithm that analyzes quarterly-aggregated features computed from data passively captured by Withings connected smart scales and step counts synced into the Withings activity-tracking ecosystem. When the predicted heart-failure risk probability exceeds a calibrated decision threshold, the device emits a notification directing the user to seek confirmatory clinical evaluation. The notification is non-diagnostic.

OTHER

Claims-based heart-failure adjudication (reference standard)

Ground-truth heart-failure case / control status derived from US HealthVerity administrative claims by a deterministic, pre-specified rule set. Per-user features (counts of HF ICD-10 codes split by inpatient vs. distinct outpatient visits, continuous-enrollment duration, supporting CPT and laboratory evidence) are passed through an ordered first-match-wins classifier. Each user is additionally assigned a claims-operationalized ACC/AHA heart-failure stage (0 / A / B / C). Adjudication is fully automated; no clinician adjudication is performed.

Locations (1)

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

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