Using a connected watch to monitor heart rhythm after cardiac surgery
Single-center Pilot Study to Evaluate the Interest of a Hybrid Connected Watch for Heart Rate Monitoring in Postoperative Cardiac Surgery
Nantes University Hospital · NCT05664308
This study is testing if a connected watch can help monitor heart rhythm in patients who have had heart surgery and experienced irregular heartbeats afterward.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 106 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nantes University Hospital (other) |
| Locations | 1 site (Nantes, Loire Atlantique) |
| Trial ID | NCT05664308 on ClinicalTrials.gov |
What this trial studies
This observational pilot study aims to utilize a hybrid connected watch for monitoring cardiac rhythm in patients who have experienced postoperative atrial fibrillation (POAF) following major cardiac surgery. The study will track the absence of recurrence or maintenance of sinus rhythm over a 12-month period, providing valuable data to assist cardiologists in managing these patients. Participants will undergo clinical follow-up and ongoing ECG monitoring to assess their heart rhythm status. The study is conducted at a single center, Nantes University Hospital.
Who should consider this trial
Good fit: Ideal candidates are adults undergoing major cardiac surgery who develop new-onset postoperative atrial fibrillation and can commit to 12 months of monitoring.
Not a fit: Patients with pre-existing atrial fibrillation or those unable to independently perform ECG measurements will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the management of postoperative atrial fibrillation, leading to better patient outcomes and reduced complications.
How similar studies have performed: While the use of connected devices for monitoring cardiac conditions is gaining traction, this specific approach in the postoperative setting is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nantes, Loire Atlantique
- CHU Nantes — Nantes, Loire Atlantique, France (RECRUITING)
Study contacts
- Study coordinator: Charles-Henri DAVID
- Email: charleshenri.david@chu-nantes.fr
- Phone: 02.44.76.85.69
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Atrial Fibrillation, Post Operative Atrial Fibrillation, Connected Watch