Connected Cardiology to Control Cardiac Rythm

NCT06091514 | Not Yet Recruiting

• 1 other identifier: APHP230642
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Atrial Fibrillation

Keywords

Connected Watch, Atrial Fibrilation (AF), Atrial Arythmia AA, Implantable Loop Recorder (ILR)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• The total number of AA episodes that lasts 5 min or more recorded on long-term monitoring

  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

  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

  between 3 and 12 months according to the period at risk of AF

• Incidence and severity of CS device vs ILR devices

  between 3 and 12 months according to the period at risk of AF

• Degree of invasiveness, comfort, and ease of use of both devices

  between 3 and 12 months according to the period at risk of AF

Study Arms (1)

Cohort group

OTHER

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; Other: Specific questionnaire

Interventions

CS Medical Watch DEVICE

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).

Cohort group

Specific questionnaire OTHER

Specific questionnaire during the last study visit (takes place at M3 to M12 according to the period at risk of AF)

Cohort group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Action Research Group: collaborator
• Hôpital Lariboisière Fernand Widal: collaborator

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Gilles MONTALESCOT, Prof

CONTACT

0142163007; gilles.montalescot@aphp.fr

Marine CAMUS, Mrs

CONTACT

0140274076; marine.camus2@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This clinical investigation is a comparative, one group, controlled study. Each patient represents its own control. Patients with an ILR already implanted for the detection of AF will receive a CS Medical Watch for a period corresponding to the period at risk of AF, up to 1 year maximum. For each patient, results obtained with the ILR device will be compared to results obtained with the CS Medical Watch device. During the conduct of the study, all medical decisions will be taken according to the ILR already implanted. No medical decision will be taken on CardiacSense System information collected during the study.

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 19, 2023
• Study Start: September 1, 2024
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: July 31, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share