Connected Cardiology to Control Cardiac Rythm (C4R)

New-onset of atrial fibrillation (AF) and atrial arrythmia (AA) in general, is important as it exposes patients to stroke or other embolic complications not to mention the risk of heart failure. AF detection in high risk populations such as patients with a recent stroke or TIA or, symptomatic patients with multiple risk factors for AF, is performed with long-term electrocardiography monitoring using frequently implantable loop recorders (ILR). These recorders have their own limitations related to the invasive nature of the device implanted under the skin of the chest with limited acceptation by the patients. Smart watches appear as useful alternatives, but they need to be evaluated in an all-comer population of patients highly exposed to AF, different from the large population studies conducted in healthy young adults with a low incidence of AF. The unique features of CardiacSense Medical System suggest that we could have an accurate noninvasive detection of AF in a selected population very much exposed to the risk of atrial fibrillation, the most frequent atrial arrhythmia.

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: CS Medical Watch; Other: Specific questionnaire

Detailed Description

Study design :

This clinical investigation is a comparative, non-randomised, one group, controlled study.

Each patient represents its own control. The study will envolve 400 participants

Hypothesis :

Our hypothesis is that CardiacSense Medical System is an effective, safe, and better accepted alternative for detecting atrial fibrillation (AF) in a high-risk population than implantable loop recorders (ILRs).

Population :

Any patient aged 18 years or more, with an ILR implanted for the detection of AF will be eligible. The time of implantation will not matter as long as the batteries work. Each patient will be proposed a CS Medical Watch for a period corresponding to the period at risk of AF.

Main objective :

To compare the performance of the CardiacSense Medical Watch by pulse plethysmography (PPG) only to the gold standard method of ILR monitoring, to detect AF that lasts 5 minutes or more, in a population of patients at high risk of paroxysmal AF.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gilles MONTALESCOT, Prof; Phone Number: +33 0142163007; Email: gilles.montalescot@aphp.fr
• Study Contact Backup: Name: Marine CAMUS, Mrs; Phone Number: +33 0140274076; Email: marine.camus2@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient aged 18 years or more
• Patient having signed free, informed, and written consent
• Patient presenting one of the following situations :
• Post-stroke or TIA patient with an already in place ILR
• Patient with symptoms evocative of AF (e.g. increased heart rate, chest pain) with an already in place ILR
• Post-PFO closure patient with an already in place ILR
• Patient in sinus rhythm treated for the prevention of paroxysmal AF with an already in place ILR
• Patient at high risk of AF (at the discretion of the investigator) with an already in place ILR
• Patient with a period of risk of AF ≥ 3 months.

Exclusion Criteria:

• Patient under legal protection
• Pregnant and/or breastfeeding women
• Patient with pacemakers, or ICD
• Patient with blood flow deficiency-related conditions
• Patient with tattoo or injured skin on the wrist
• Patient with tremors or otherwise unable to remain still for 15 minutes
• Patient without two hands and sufficient fingers to complete the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Cohort group; Patients will be followed during a period ranging from 3 to 12 months depending on his period at risk of AF. This period will be defined at the inclusion visit. During this period, the patient will be followed as part of usual care, considering the medical informations given by the ILR device already implanted. During this period, the patient will have to wear the watch permanently outside charging time. Moreover, he will have to realize ECG measurement when the Medical Watch will indicate it. The patient could also trigger an ECG measurement if he feels the need.

Device: CS Medical Watch; The Use of the CS Medical Watch during the participation period of the clinical investigation (between 3 and 12 months according to the period at risk of AF).; Other: Specific questionnaire; Specific questionnaire during the last study visit (takes place at M3 to M12 according to the period at risk of AF)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The total number of episodes AF that lasts 5 min or more recorded on long-term monitoring	The total number of episodes AF that lasts 5 min or more recorded on long-term monitoring using the CardiacSense Medical Watch by pulse plethysmography (PPG) only vs the gold standard method of ILR ECG recording, over the same period of monitoring by the two devices for each patient.	between 3 and 12 months according to the period at risk of AF

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The total number of AA episodes that lasts 5 min or more recorded on long-term monitoring	The total number of AA episodes that lasts 5 min or more detected by PPG and confirmed by ECG measurement of the CardiacSense Medical Watch (vs. ILR ECG recording) over the same period of monitoring by the two devices for each patient.	between 3 and 12 months according to the period at risk of AF
The total number of episodes AF that lasts 5 min or more recorded on long-term monitoring	Same primary endpoint for symptomatic patients vs. asymptomatic patients	between 3 and 12 months according to the period at risk of AF
The total duration of AF episodes that lasts 5 min or more	Total duration of AF episodes that lasts 5 min or more / total duration of monitoring expressed in % for each device (PPG CS watch only vs. ILR ECG recording).	between 3 and 12 months according to the period at risk of AF
Incidence and severity of CS device vs ILR devices	Related Adverse Events and incidents during the patient participation	between 3 and 12 months according to the period at risk of AF
Degree of invasiveness, comfort, and ease of use of both devices	Description : measured using specific questionnaires for the study	between 3 and 12 months according to the period at risk of AF
Medico-economic evaluation according to the AP-HP hospital costs	The cost of each medical device (considering the replacement when needed over the study period for each patient); The cost for extra-consultation/hospitalization for surgery, complication, or education.	between 3 and 12 months according to the period at risk of AF

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Action Research Group; Hôpital Lariboisière Fernand Widal

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: October 16, 2023
• First Submitted That Met QC Criteria: October 16, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Actual): July 31, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Connected Watch, Atrial Fibrilation (AF), Atrial Arythmia AA, Implantable Loop Recorder (ILR)
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: APHP230642

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No