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

NCT05664308 | Recruiting

• 1 other identifier: RC22_0604
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

Post Operative Atrial Fibrillation; Connected Watch

Outcome Measures

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

  12 months

Secondary Outcomes (7)

• Assessment of the rate of patients on anticoagulant therapy by follow-up modality

  12 months

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

  12 months

• Assessment of the number of patients in AF

  12 months

• Assessment of the duration of AF transitions

  12 months

• Assessment of quality of life and satisfaction with use by follow-up modality

  12 months

Study Arms (2)

Electrocardiogram

Other: Clinical follow-up (ECG)

Electrocardiogram + Connect Watch

Other: Clinical follow-up (ECG); Other: Ongoing monitoring

Interventions

Clinical follow-up (ECG) OTHER

Clinical follow-up with a consultation at the University Hospital at 3, 6, and 12 months, with an ECG at each visit.

Electrocardiogram; Electrocardiogram + Connect Watch

Ongoing monitoring OTHER

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.

Electrocardiogram + Connect Watch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with postoperative atrial fibrillation meeting the study eligibility criteria

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

CHU Nantes

Nantes, Loire Atlantique, 44093, France

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

epicatechin gallate

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Charles-Henri DAVID

CONTACT

02.44.76.85.69; charleshenri.david@chu-nantes.fr

Imen FELLAH

CONTACT

02.40.16.51.02; Imen.FELLAH@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: December 23, 2022
• Study Start: March 19, 2024
• Primary Completion: March 19, 2026
• Study Completion (Estimated): March 19, 2028
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

FR (1)