Clinical trial NCT05664308: Interest of a Hybrid Connected Watch for Cardiac Rhythm Monitoring in Post-operative Cardiac Surgery
Official title: Single-center Pilot Study to Evaluate the Interest of a Hybrid Connected Watch for Heart Rate Monitoring in Postoperative Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Keywords: Post Operative Atrial Fibrillation
Connected Watch
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2022-12-23
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with postoperative atrial fibrillation meeting the study eligibility criteria

Brief summary: 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: 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

Primary outcomes:
measure: 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
timeFrame: 12 months
Secondary outcomes:
measure: Assessment of the rate of patients on anticoagulant therapy by follow-up modality
timeFrame: 12 months
measure: Evaluation of complication rates related to the different treatments according to the follow-up modality
timeFrame: 12 months
measure: Assessment of the number of patients in AF
timeFrame: 12 months
measure: Assessment of the duration of AF transitions
timeFrame: 12 months
measure: Assessment of quality of life and satisfaction with use by follow-up modality
timeFrame: 12 months
measure: Assessment of quality of life and satisfaction with use by follow-up modality
timeFrame: 12 months
measure: Evaluate the appropriateness of each of the two modalities with treating cardiologists
timeFrame: 12 months
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU Nantes
state: Loire Atlantique
Study officials:
References: