Comparison Between "Conventional Monitoring" Versus "Monitoring Via Vitaphone" in the Detection of Post Ablation Atrial Arrhythmias of Paroxysmal Atrial Fibrillation (VITAPHONE)

Ramsay Générale de Santé

Status and phase: Unknown; Phase 4

Conditions: Atrial Fibrillation

Treatments: Device: ECG monitoring & record; Other: Conventional follow-up

Study type: Interventional

Funder types: Other

Identifiers

NCT03966976

2017-A01813-50

Details and patient eligibility

About

Atrial fibrillation (AF) is the most common atrial arrhythmia. Ablation of AF is a recent technique, nevertheless, the success rates of ablation vary between 50% and 70% depending on the paroxysmal or persistent nature of AF. These rates are difficult to assess in routine practice because they are based on the recurrence of fibrillation.

The Vitaphone is a non-invasive device, with which the patient can record a single-track ECG as his or her symptoms take place. The plot is then transmitted via the internet to the centre, which can thus diagnose a relapse of AF.

The aim of our study is to correlate the rhythm and symptoms of 20 patients with Vitaphone 6 months after AF ablation and to compare them with 20 other patients receiving conventional monitoring.

Full description

Atrial fibrillation (AF) is the most common atrial arrhythmia in the population and its incidence will increase in the coming years. Ablation of AF is a recent technique, the efficiency of which has considerably increased in recent years. Nevertheless, the success rates of ablation vary between 50% and 70% depending on the paroxysmal or persistent nature of AF. These rates are difficult to assess in routine practice because they are based on the recurrence of fibrillation.

This definition of recurrence based on symptoms (palpitations, asthenia, fatigue, shortness of breath, malaise, precordialgia) is widely debated because some patients have asymptomatic AF recidivism, while others experience palpitations that are not due to AF.

In this context, studies have been carried out with electrocardiographic recording devices implanted subcutaneously. Given the invasiveness of this monitoring, it is not feasible in current practice.

The Vitaphone is a non-invasive device, with which the patient can record a single-track ECG as his or her symptoms take place. The plot is then transmitted via the internet to the centre, which can thus diagnose a relapse of AF.

The aim of our study is to correlate the rhythm and symptoms of 20 patients with Vitaphone 6 months after AF ablation and to compare them with 20 other patients receiving conventional monitoring.

This is, to our knowledge, the first non-invasive French study using the Vitaphone.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• AF ablated patient
• Patient with paroxysmal AF before the procedure
• Patient with health insurance or beneficiary of a social security scheme
• Unprotected adult patient
• Patient having given their consent

Exclusion criteria

• Patient having undergone an AF ablation due to persistent AF
• Unable to understand or handle the Vitaphone alone
• Failure to participate
• Minors
• Pregnant, lactating or parturient women
• Adult receiving psychiatric care, under legal protection, trusteeship or guardianship, or deprived of liberty by judicial or administrative decision

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Vitaphone Arm

Experimental group

Description:

Follow-up via VITAPHONE in addition to conventional monitoring.

Treatment:

Device: ECG monitoring & record

Conventional Arm

Active Comparator group

Description:

Conventional follow-up

Treatment:

Other: Conventional follow-up