Recruiting NCT05664308
Interest of a Hybrid Connected Watch for Cardiac Rhythm Monitoring in Post-operative Cardiac Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Clinical follow-up (ECG), Ongoing monitoring.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Single-center Pilot Study to Evaluate the Interest of a Hybrid Connected Watch for Heart Rate Monitoring in Postoperative Cardiac Surgery
Overview
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.
Interventions
- 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. - 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.
Primary outcome measures
- 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 [Time frame: 12 months]
Secondary outcome measures (7)
- Assessment of the rate of patients on anticoagulant therapy by follow-up modality [Time frame: 12 months]
- Evaluation of complication rates related to the different treatments according to the follow-up modality [Time frame: 12 months]
- Assessment of the number of patients in AF [Time frame: 12 months]
- Assessment of the duration of AF transitions [Time frame: 12 months]
- Assessment of quality of life and satisfaction with use by follow-up modality [Time frame: 12 months]
- Assessment of quality of life and satisfaction with use by follow-up modality [Time frame: 12 months]
- Evaluate the appropriateness of each of the two modalities with treating cardiologists [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
France · 1 center
- CHU Nantes — Nantes
Identifiers
NCT: NCT05664308 · RC22_0604