Single-center Pilot Study to Evaluate the Interest of a Hybrid Connected Watch for Heart Rate Monitoring in Postoperative Cardiac Surgery
Overview
- Phase
- N/A
- Intervention
- Clinical follow-up (ECG)
- Conditions
- Atrial Fibrillation
- Sponsor
- Nantes University Hospital
- Enrollment
- 106
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Recruiting
- Last Updated
- 3 months ago
Overview
Brief 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.
Investigators
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...)
- •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
Arms & Interventions
Electrocardiogram
Intervention: Clinical follow-up (ECG)
Electrocardiogram + Connect Watch
Intervention: Clinical follow-up (ECG)
Electrocardiogram + Connect Watch
Intervention: Ongoing monitoring
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Evaluation of complication rates related to the different treatments according to the follow-up modality(12 months)
- Evaluate the appropriateness of each of the two modalities with treating cardiologists(12 months)
- Assessment of the rate of patients on anticoagulant therapy by follow-up modality(12 months)
- Assessment of the duration of AF transitions(12 months)
- Assessment of the number of patients in AF(12 months)
- Assessment of quality of life and satisfaction with use by follow-up modality(12 months)