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Clinical Trials in France / NCT05664308
Recruiting Observational

Interest of a Hybrid Connected Watch for Cardiac Rhythm Monitoring in Post-operative Cardiac Surgery

NCT05664308 · tracked via the Priya Life Science France tracker
Sponsor
Nantes University Hospital
Phase
Observational
Started
2024-03-19
Last updated
2026-09-29

Condition(s) studied

Atrial Fibrillation

Investigational drug(s) / intervention(s)

Clinical follow-up (ECG)Ongoing monitoring

Clinical follow-up (ECG): Clinical follow-up with a consultation at the University Hospital at 3, 6, and 12 months, with an ECG at each visit.

Ongoing monitoring: Once operated, patients will be monitored remotely via a computerized data transfer routine anonymized by the WITHINGS software, based on the data from the watch. It's contractually agreed with WITHINGS that the transmissions will be scheduled and transmitted weekly to the center.

Study summary

The objective of this single-center pilot study is, with the help of a connected watch, to show the absence of recurrence or maintenance of sinus rhythm in patients with a Post Operative Atrial Fibrillation (POAF) and to help treating cardiologists in the care of these patients.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Major with an indication for conventional cardiac surgery with de novo postoperative AF onset. * Agreeing to participate in the study and having signed an informed consent. * Agreeing to undergo 12 months of postoperative monitoring. Exclusion Criteria: * Patient with pre-operative AF * Patient who does not have a smartphone compatible with the connected watch. * Patient unable to perform an ECG measurement independently. * Patient with a physical constraint to the measurement (arteriovenous fistula...) * Minors * Pregnant or breast-feeding women * Adults under guardianship, under curatorship * Patients whose life expectancy is less than 1 year * Patients participating in another therapeutic trial likely to impact the evaluation criteria of the MONHYCARD study * Contraindication to long-term anticoagulants * Patients implanted with a mechanical valve prosthesis pre-operatively or after surgery

Primary outcome measure(s)

  • To compare the rate of recurrence of paroxysmal or persistent atrial fibrillation with continuous 12-month postoperative cardiac surgery monitoring in patients with POAF versus traditional follow-up with ECG recording at 3, 6 and 12 months — 12 months
    Recurrence rate of paroxysmal or persistent Atrial Fibrillation (AF) (ESC 2020 Definition) over a 12-month follow-up period post cardiac surgery according to traditional ECG monitoring at 3, 6, and 12 months more or less combined with connected watch monitoring

Trial sites (1)

FacilityCityRegionStatus
CHU Nantes Nantes Loire Atlantique Recruiting

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Biological Bank for Atrial Fibrillation and Stroke Recruiting
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05664308 on ClinicalTrials.gov ↗ ← All trials in France