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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electrocardiogram |
| ||
| Electrocardiogram + Connect Watch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with postoperative atrial fibrillation meeting the study eligibility criteria
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Charles-Henri DAVID | Contact | 02.44.76.85.69 | charleshenri.david@chu-nantes.fr | |
| Imen FELLAH | Contact | 02.40.16.51.02 | Imen.FELLAH@chu-nantes.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Nantes | Recruiting | Nantes | Loire Atlantique | 44093 | France |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C062669 | epicatechin gallate |
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| 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. |
|
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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |