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

Официальное название

Single-center Pilot Study to Evaluate the Interest of a Hybrid Connected Watch for Heart Rate Monitoring in Postoperative Cardiac Surgery

Обзор

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.

Вмешательства

• Другое 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.
• Другое 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.

Первичные конечные точки

• 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 [Срок оценки: 12 months]

Вторичные конечные точки (7)

• Assessment of the rate of patients on anticoagulant therapy by follow-up modality [Срок оценки: 12 months]
• Evaluation of complication rates related to the different treatments according to the follow-up modality [Срок оценки: 12 months]
• Assessment of the number of patients in AF [Срок оценки: 12 months]
• Assessment of the duration of AF transitions [Срок оценки: 12 months]
• Assessment of quality of life and satisfaction with use by follow-up modality [Срок оценки: 12 months]
• Assessment of quality of life and satisfaction with use by follow-up modality [Срок оценки: 12 months]
• Evaluate the appropriateness of each of the two modalities with treating cardiologists [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Франция · 1 центр

• CHU Nantes — Nantes

Идентификаторы

NCT: NCT05664308 · RC22_0604

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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