Diagnosis of Postoperative Atrial Fibrillation by a Smartwatch (FAWATCH)
Primary Purpose
Atrial Fibrillation, Cardiac Surgery
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ECG
scanwatch
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation focused on measuring smartwatch, Atrial Fibrillation, perioperative atrial fibrillation, cardiac surgery
Eligibility Criteria
Inclusion Criteria:
- Adult patient (>18 years old)
- The patient was hospitalized at Amiens University Hospital for on-pump cardiac surgery.
- The patient has had a recent on-pump cardiac surgery (< 96h)
- Patient with the motor and cognitive abilities to perform a 1-lead ECG with the smartwatch
- The patient was transferred to the cardiac surgery department of Amiens University Hospital.
- The beneficiary of a social security plan
- Signature of the consent to participate in the study
Exclusion Criteria:
- History of AF
- Need for rhythmic monitoring by telemetry in cardiac intensive care for atrioventricular block and rapid supra and ventricular rhythm disorder (>140 bpm).
- An external pacemaker connected to epicardial electrodes depends on ventricular and atrial pacing.
- Patients already included in an interventional clinical research protocol may alter the incidence of POAF.
- Pregnant woman
Sites / Locations
- CHU Amiens PicardieRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
smartwatches group
no smartwatche group
Arm Description
Outcomes
Primary Outcome Measures
Variation of POAF incidence between both groups
The incidence of POAF will be compared between the two arms
Secondary Outcome Measures
percentage of asymptomatic PAOF in the SW arm
Full Information
NCT ID
NCT05573633
First Posted
October 6, 2022
Last Updated
October 6, 2022
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT05573633
Brief Title
Diagnosis of Postoperative Atrial Fibrillation by a Smartwatch
Acronym
FAWATCH
Official Title
Diagnosis of Postoperative Atrial Fibrillation After Cardiac Surgery by a Smartwatch: an Open-label Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 6, 2022 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
April 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The incidence of postoperative atrial fibrillation (POAF) after on-pump cardiac surgery remains high, at around 30%. POAF increases the risk of cardiac decompensation, stroke, acute myocardial infarction, and death, resulting in increased morbidity and mortality, hospital length of stay, and cost of patient management. Episodes of POAF are usually paroxysmal and asymptomatic, increasing the risk of developing permanent AF at five years by 4 to 5 times. POAF occurs between 3 and 4 days after cardiac surgery, mainly when the patient is hospitalized in a surgical ward without heart rate monitoring as opposed to critical care, where the patient benefits from continuous rhythmic monitoring. The diagnosis of POAF is therefore made with the help of a 12-lead electrocardiogram (ECG) when the patient presents clinical symptoms and when the medical staff notes a significant variation in heart rate. However, many patients with episodes of asymptomatic POAF have a higher risk of stroke and mortality than those with symptomatic POAF.
Faced with this public health problem, the development of tools for diagnosing AF is in full swing, mainly the marketing of smartwatches (SWs) that allow for the performance of 1-lead ECG. SW is also equipped with algorithms to analyze heart rate variability and diagnose asymptomatic atrial fibrillation (AF) episodes. The European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) recommend the use of smartwatches to detect AF, in particular, to reduce the economic impact of AF.
The aim of the study is to diagnose POAF within the first five days after patient discharge from the critical care unit for the cardiac surgery department.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Cardiac Surgery
Keywords
smartwatch, Atrial Fibrillation, perioperative atrial fibrillation, cardiac surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
358 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
smartwatches group
Arm Type
Experimental
Arm Title
no smartwatche group
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
ECG
Intervention Description
the POAF will be diagnosed using a 12-lead ECG and according to the usual monitoring protocols for patients in the cardiac surgery department of Amiens University Hospital.
Intervention Type
Procedure
Intervention Name(s)
scanwatch
Intervention Description
POAF will be diagnosed with a Withings SM (ScanWatch). FAPO diagnosed by the SW will have to be confirmed by a 12-lead ECG.
Primary Outcome Measure Information:
Title
Variation of POAF incidence between both groups
Description
The incidence of POAF will be compared between the two arms
Time Frame
5 days
Secondary Outcome Measure Information:
Title
percentage of asymptomatic PAOF in the SW arm
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patient (>18 years old)
The patient was hospitalized at Amiens University Hospital for on-pump cardiac surgery.
The patient has had a recent on-pump cardiac surgery (< 96h)
Patient with the motor and cognitive abilities to perform a 1-lead ECG with the smartwatch
The patient was transferred to the cardiac surgery department of Amiens University Hospital.
The beneficiary of a social security plan
Signature of the consent to participate in the study
Exclusion Criteria:
History of AF
Need for rhythmic monitoring by telemetry in cardiac intensive care for atrioventricular block and rapid supra and ventricular rhythm disorder (>140 bpm).
An external pacemaker connected to epicardial electrodes depends on ventricular and atrial pacing.
Patients already included in an interventional clinical research protocol may alter the incidence of POAF.
Pregnant woman
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christophe Beyls, MD
Phone
03 22 08 78 66
Email
beyls.christophe@chu-amiens.fr
Facility Information:
Facility Name
CHU Amiens Picardie
City
Amiens
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe Beyls, MD
Phone
0322087866
Email
Beyls.Christophe@chu-amiens.fr
12. IPD Sharing Statement
Plan to Share IPD
No
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Diagnosis of Postoperative Atrial Fibrillation by a Smartwatch
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