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RecruitingNCT05664308MONHYCARDUpdated Sep 29, 2026

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

An observational study in Atrial Fibrillation, sponsored by Nantes University Hospital. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Nantes University Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
106
Ages
18 Years and older
Sex
All
01

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.

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Conditions studied

  • Atrial Fibrillation

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Keywords

  • Post Operative Atrial Fibrillation
  • Connected Watch
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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with postoperative atrial fibrillation meeting the study eligibility criteria

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

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
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
106 participants (estimated)
Patient registry
No

Groups and cohorts

  • Electrocardiogram

    Other: Clinical follow-up (ECG)

  • Electrocardiogram + Connect Watch

    Other: Clinical follow-up (ECG) · Other: Ongoing monitoring

Interventions

  • OtherClinical 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.

  • OtherOngoing 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.

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What researchers measure

Primary outcomes

  1. 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

    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

    Time frame: 12 months

Secondary outcomes

  1. Assessment of the rate of patients on anticoagulant therapy by follow-up modality

    Rate of anticoagulant use at 3, 6, and 12 months according to rhythm status in both modalities

    Time frame: 12 months

  2. Evaluation of complication rates related to the different treatments according to the follow-up modality

    Cardiovascular mortality, ischemic stroke, anticoagulant-related events

    Time frame: 12 months

  3. Assessment of the number of patients in AF

    Postoperative AF rate in each group

    Time frame: 12 months

  4. Assessment of the duration of AF transitions

    Postoperative AF rate over periods of more than 6 hours and/or 12 hours

    Time frame: 12 months

  5. Assessment of quality of life and satisfaction with use by follow-up modality

    European Quality of Life-5 Dimensions (EQ-5D), (the maximum value is 3 (wich is the worse outcome) and the minimum is 1 (wich is the best outcome)), before intervention, at 3, 6 and 12 months

    Time frame: 12 months

  6. Assessment of quality of life and satisfaction with use by follow-up modality

    Hospital Anxiety and Depression scale (HAD) scores, (the maximum value is 21 (wich is the worse outcome) and the minimum is 0 (wich is the best outcome)), before intervention, at 3, 6 and 12 months

    Time frame: 12 months

  7. Evaluate the appropriateness of each of the two modalities with treating cardiologists

    Satisfaction questionnaire for treating cardiologists

    Time frame: 12 months

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Study locations

1 of 1 sites recruiting
  • CHU Nantes
    Nantes, Loire Atlantique 44093, France
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05664308
Lead sponsor
Nantes University Hospital
Responsible party
Sponsor
First posted
Dec 23, 2022
Start date
Mar 19, 2024
Primary completion
Mar 19, 2028 (estimated)
Completion
Mar 19, 2029 (estimated)
Last update
Sep 29, 2026

Study contacts

Charles-Henri DAVID
Contact
charleshenri.david@chu-nantes.fr
02.44.76.85.69
Imen FELLAH
Contact
Imen.FELLAH@chu-nantes.fr
02.40.16.51.02

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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