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

N

Nantes University Hospital (NUH)

Status

Enrolling

Conditions

Atrial Fibrillation

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT05664308
RC22_0604

Details and patient eligibility

About

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.

Enrollment

106 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

106 participants in 2 patient groups

Electrocardiogram
Treatment:
Other: Clinical follow-up (ECG)
Electrocardiogram + Connect Watch
Treatment:
Other: Ongoing monitoring
Other: Clinical follow-up (ECG)

Trial contacts and locations

1

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Central trial contact

Imen FELLAH; Charles-Henri DAVID

Data sourced from clinicaltrials.gov

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