Connected Cardiology to Control Cardiac Rythm

NCT ID: NCT06091514

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2026-02-28

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.

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

CS Medical Watch

Intervention Type: 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).

Specific questionnaire

Intervention Type: OTHER

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

Interventions

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).

Intervention Type: DEVICE

Specific questionnaire

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Action Research Group

OTHER

Sponsor Role: collaborator

Hôpital Lariboisière Fernand Widal

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Gilles MONTALESCOT, Prof

Role: CONTACT

gilles.montalescot@aphp.fr

0142163007 ext. +33

Marine CAMUS, Mrs

Role: CONTACT

marine.camus2@aphp.fr

0140274076 ext. +33

Other Identifiers

APHP230642

Identifier Type: -

Identifier Source: org_study_id