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

Atrial Fibrillation Clinical Trial

— MONHYCARD  

Official title:

Single-center Pilot Study to Evaluate the Interest of a Hybrid Connected Watch for Heart Rate Monitoring in Postoperative Cardiac Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05664308
• Other study ID #: RC22_0604
• Status: Recruiting
• Start date: March 19, 2024
• Est. completion date: March 19, 2026

Study information

• Verified date: April 2024
• Source: Nantes University Hospital
• Contact: Charles-Henri DAVID
• Phone: 02.44.76.85.69
• Email: charleshenri.david[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: March 19, 2026
• Est. primary completion date: March 19, 2026
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• Clinical follow-up (ECG)
Clinical follow-up with a consultation at the University Hospital at 3, 6, and 12 months, with an ECG at each visit.
• Ongoing monitoring
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.

Locations

Country	Name	City	State
France	CHU Nantes	Nantes	Loire Atlantique

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Evaluation of complication rates related to the different treatments according to the follow-up modality	Cardiovascular mortality, ischemic stroke, anticoagulant-related events	12 months
Secondary	Assessment of the number of patients in AF	Postoperative AF rate in each group	12 months
Secondary	Assessment of the duration of AF transitions	Postoperative AF rate over periods of more than 6 hours and/or 12 hours	12 months
Secondary	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
Secondary	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
Secondary	Evaluate the appropriateness of each of the two modalities with treating cardiologists	Satisfaction questionnaire for treating cardiologists	12 months