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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNantes University Hospital

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Clinical follow-up (ECG)

    Other intervention

    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 intervention

    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.

Treatment groups

106 Participants
are divided into 2 treatment groups
Group A: Electrocardiogram1 intervention
Group B: Electrocardiogram + Connect Watch2 interventions

Trial outcomes

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

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

Time frame
12 months

Secondary outcomes

1

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

Time frame
12 months
2

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

Cardiovascular mortality, ischemic stroke, anticoagulant-related events

Time frame
12 months
3

Assessment of the number of patients in AF

Postoperative AF rate in each group

Time frame
12 months
4

Assessment of the duration of AF transitions

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

Time frame
12 months

Other outcomes

Sponsors and contacts

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