Connected Cardiology to Control Cardiac Rythm

Atrial Fibrillation Clinical Trial

— C4R  

Official title:

Connected Cardiology to Control Cardiac Rythm

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06091514
• Other study ID #: APHP230642
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: February 2026

Study information

• Verified date: October 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Gilles MONTALESCOT, Prof
• Phone: 0142163007
• Email: gilles.montalescot[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: February 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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)

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Action Research Group, Hôpital Lariboisière Fernand Widal

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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