Atrial FibrillationMONHYCARDNCT05664308
Interest of a Hybrid Connected Watch for Cardiac Rhythm Monitoring in Post-operative Cardiac Surgery
An observational study of Atrial Fibrillation, run by Nantes University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Clinical follow-up (ECG) and Ongoing monitoring
- How many people
- 106 participants
- Where
- 1 siteFrance
- Study dates
- 19 Mar 2024to 19 Mar 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with postoperative atrial fibrillation meeting the study eligibility criteria
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Nantes
Nantes, Loire Atlantique, 44093
Charles-Henri DAVID, 02 44 76 85 69, charleshenri.david@chu-nantes.fr
Charles-Henri DAVID
About this study
Official title: Single-center Pilot Study to Evaluate the Interest of a Hybrid Connected Watch for Heart Rate Monitoring in Postoperative Cardiac Surgery
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
- Being tested
- Clinical follow-up (ECG), Ongoing monitoring
- Keywords
- Post Operative Atrial Fibrillation, Connected Watch
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Ongoing monitoringOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Electrocardiogram | Not described Receives: Other: Clinical follow-up (ECG) | |
| Electrocardiogram + Connect Watch | Not described Receives: Other: Clinical follow-up (ECG); Other: Ongoing monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (7)
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
Measured: 12 months
Evaluation of complication rates related to the different treatments according to the follow-up modality
Cardiovascular mortality, ischemic stroke, anticoagulant-related events
Measured: 12 months
Assessment of the number of patients in AF
Postoperative AF rate in each group
Measured: 12 months
Assessment of the duration of AF transitions
Postoperative AF rate over periods of more than 6 hours and/or 12 hours
Measured: 12 months
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
Measured: 12 months
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
Measured: 12 months
Evaluate the appropriateness of each of the two modalities with treating cardiologists
Satisfaction questionnaire for treating cardiologists
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start19 Mar 2024
- Primary completion19 Mar 2028 (estimated)
- Study completion19 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05664308
- Sponsor's protocol ID
- RC22_0604
- Acronym
- MONHYCARD
- Status last verified
- Sep 2026
- First submitted
- 14 Dec 2022
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center Pilot Study to Evaluate the Interest of a Hybrid Connected Watch for Heart Rate Monitoring in Postoperative Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05664308
- Acronym / sponsor ID
- MONHYCARD / RC22_0604
- Conditions
- Atrial Fibrillation
- Keywords
- Post Operative Atrial Fibrillation, Connected Watch
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- 19 Mar 2028 (estimated)
- Study completion
- 19 Mar 2029 (estimated)
- First posted
- 23 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrocardiogram | – | Other: Clinical follow-up (ECG) |
| Electrocardiogram + Connect Watch | – | Other: Clinical follow-up (ECG), Other: Ongoing monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with postoperative atrial fibrillation meeting the study eligibility criteria
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Electrocardiogram, Electrocardiogram + Connect Watch |
| Ongoing monitoringOnce 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. | Other | Electrocardiogram + Connect Watch |
Primary outcome
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
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
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charles-Henri DAVID (02.44.76.85.69, charleshenri.david@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.