Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05664308

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Nantes

Nantes, Loire Atlantique, 44093, France

Location status: Recruiting

Location contact

Charles-Henri DAVID

CONTACT

[email protected]

02 44 76 85 69

Charles-Henri DAVID

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clinical follow-up (ECG)

Other

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

Ongoing monitoring

Other

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.

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

    Time frame: 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

Secondary outcomes

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

    Time frame: 12 months

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

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

    Time frame: 12 months

    Cardiovascular mortality, ischemic stroke, anticoagulant-related events

  3. Assessment of the number of patients in AF

    Time frame: 12 months

    Postoperative AF rate in each group

  4. Assessment of the duration of AF transitions

    Time frame: 12 months

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

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

    Time frame: 12 months

    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

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

    Time frame: 12 months

    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

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

    Time frame: 12 months

    Satisfaction questionnaire for treating cardiologists

Study contacts

Contact information is provided by the study sponsor or research team.

Charles-Henri DAVID

CONTACT

[email protected]

02.44.76.85.69

Imen FELLAH

CONTACT

[email protected]

02.40.16.51.02

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

Single-center Pilot Study to Evaluate the Interest of a Hybrid Connected Watch for Heart Rate Monitoring in Postoperative Cardiac Surgery

Acronym: MONHYCARD

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Dec 23, 2022
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.