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

Atrial Fibrillation Clinical Trial

— VITAPHONE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03966976
• Other study ID #: 2017-A01813-50
• Status: Recruiting
• Phase: Phase 4
• Start date: March 15, 2018
• Est. completion date: September 30, 2020

Study information

• Verified date: May 2019
• Source: Ramsay Générale de Santé
• Contact: Jean Francois OUDET
• Phone: +33683346567
• Email: jf.oudet[@]ecten.eu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
France	CRRIC Clairval Interventional Rhythmology Research Centre Clairval Private Hospital	Marseille	Paca

Sponsors (2)

Lead Sponsor	Collaborator
Ramsay Générale de Santé	Dr Alexis MECHULAN

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence rate of AF between 3 and 6 months	Atrial arrhythmia documented in each arm by either an ECG or Holter or Vitaphone between 3 and 6 months post-ablation of paroxysmal AF and validated by a cardiologist.	3 to 6 months