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

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

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Other: Clinical follow-up (ECG); Other: Ongoing monitoring

• Study Type: Observational
• Enrollment (Estimated): 106

Contacts and Locations

• Study Contact: Name: Charles-Henri DAVID; Phone Number: 02.44.76.85.69; Email: charleshenri.david@chu-nantes.fr
• Study Contact Backup: Name: Imen FELLAH; Phone Number: 02.40.16.51.02; Email: Imen.FELLAH@chu-nantes.fr

Study Locations

• France
  • Loire Atlantique
    • Nantes, Loire Atlantique, France, 44093
      • Recruiting
      • CHU Nantes
      • Contact: Charles-Henri DAVID; Phone Number: 02 44 76 85 69; Email: charleshenri.david@chu-nantes.fr
      • Principal Investigator: Charles-Henri DAVID

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with postoperative atrial fibrillation meeting the study eligibility criteria

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Electrocardiogram	Other: 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.
Electrocardiogram + Connect Watch	Other: 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.; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months
Evaluation of complication rates related to the different treatments according to the follow-up modality	Cardiovascular mortality, ischemic stroke, anticoagulant-related events	12 months
Assessment of the number of patients in AF	Postoperative AF rate in each group	12 months
Assessment of the duration of AF transitions	Postoperative AF rate over periods of more than 6 hours and/or 12 hours	12 months
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	12 months
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	12 months
Evaluate the appropriateness of each of the two modalities with treating cardiologists	Satisfaction questionnaire for treating cardiologists	12 months

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2024
• Primary Completion (Estimated): March 19, 2026
• Study Completion (Estimated): March 19, 2028

Study Registration Dates

• First Submitted: December 14, 2022
• First Submitted That Met QC Criteria: December 22, 2022
• First Posted (Actual): December 23, 2022

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Post Operative Atrial Fibrillation; Connected Watch
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation; epicatechin gallate
• Other Study ID Numbers: RC22_0604

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No