About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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...)
Trial population
Patients with postoperative atrial fibrillation meeting the study eligibility criteria
Trial design
Other
Prospective
Treatments tested in this trial
Clinical follow-up (ECG)
Other interventionClinical follow-up with a consultation at the University Hospital at 3, 6, and 12 months, with an ECG at each visit.
Ongoing monitoring
Other interventionOnce 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.
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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
Evaluation of complication rates related to the different treatments according to the follow-up modality
Cardiovascular mortality, ischemic stroke, anticoagulant-related events
Assessment of the number of patients in AF
Postoperative AF rate in each group
Assessment of the duration of AF transitions
Postoperative AF rate over periods of more than 6 hours and/or 12 hours
Sponsors and contacts
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