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

Recruiting

• Conditions: Atrial Fibrillation
• Interventions: Other: Clinical follow-up (ECG); Other: Ongoing monitoring

• Registration Number: NCT05664308
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-14
• Study First Submitted QC: 2022-12-22
• Study First Posted: 2022-12-23
• Study Start: 2024-03-19
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-18
• Primary Completion: 2026-03-19
• Study Completion: 2026-03-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Electrocardiogram	Clinical follow-up (ECG)	-
Electrocardiogram + Connect Watch	Clinical follow-up (ECG)	-
Electrocardiogram + Connect Watch	Ongoing monitoring	-

Primary Outcome Measures

Name	Time	Method
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	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 Outcome Measures

Name	Time	Method
Evaluation of complication rates related to the different treatments according to the follow-up modality	12 months	Cardiovascular mortality, ischemic stroke, anticoagulant-related events
Evaluate the appropriateness of each of the two modalities with treating cardiologists	12 months	Satisfaction questionnaire for treating cardiologists
Assessment of the rate of patients on anticoagulant therapy by follow-up modality	12 months	Rate of anticoagulant use at 3, 6, and 12 months according to rhythm status in both modalities
Assessment of the duration of AF transitions	12 months	Postoperative AF rate over periods of more than 6 hours and/or 12 hours
Assessment of quality of life and satisfaction with use by follow-up modality	12 months	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
Assessment of the number of patients in AF	12 months	Postoperative AF rate in each group

Trial Locations

Locations (1)

CHU Nantes; 🇫🇷 Nantes, Loire Atlantique, France