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

Study Overview
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Brief Summary
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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.

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

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Other: Clinical follow-up (ECG)
* Other: Ongoing monitoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Electrocardiogram<br> | Other: Clinical follow-up (ECG)<br>* Clinical follow-up with a consultation at the University Hospital at 3, 6, and 12 months, with an ECG at each visit.<br>|
| Electrocardiogram + Connect Watch<br> | Other: Clinical follow-up (ECG)<br>* Clinical follow-up with a consultation at the University Hospital at 3, 6, and 12 months, with an ECG at each visit.<br>Other: Ongoing monitoring<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post Operative Atrial Fibrillation, Connected Watch