NCT03966976

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Ramsay Générale de Santé · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	ECG monitoring & record	This is a mobile ECG recorder that not only records short portions of ECG on one or three leads, but also stores, processes and transmits their data to facilitate the diagnosis and to confirm the occurrence of AF arrhythmia episodes by the physician.
OTHER	Conventional follow-up	Conventional follow-up

Timeline

• Start date: 2018-03-15
• Primary completion: 2020-09-30
• Completion: 2020-09-30
• First posted: 2019-05-29
• Last updated: 2019-05-29

Locations

1 site across 1 country: France