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

NCT ID: NCT05664308

Last Updated: 2026-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

106 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-19

Study Completion Date

2028-03-19

Brief Summary

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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

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Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Electrocardiogram

Clinical follow-up (ECG)

Intervention Type OTHER

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

Electrocardiogram + Connect Watch

Clinical follow-up (ECG)

Intervention Type OTHER

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

Ongoing monitoring

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Nantes

Nantes, Loire Atlantique, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Charles-Henri DAVID

Role: CONTACT

02.44.76.85.69

Imen FELLAH

Role: CONTACT

02.40.16.51.02

Facility Contacts

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Charles-Henri DAVID

Role: primary

02 44 76 85 69

Other Identifiers

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RC22_0604

Identifier Type: -

Identifier Source: org_study_id

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