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

NCT ID: NCT03966976

Last Updated: 2019-05-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-15
• Study Completion Date: 2020-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Vitaphone Arm

Follow-up via VITAPHONE in addition to conventional monitoring.

Group Type: EXPERIMENTAL

ECG monitoring & record

Intervention Type: DEVICE

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.

Conventional Arm

Conventional follow-up

Group Type: ACTIVE_COMPARATOR

Conventional follow-up

Intervention Type: OTHER

Conventional follow-up

Interventions

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.

Intervention Type: DEVICE

Conventional follow-up

Conventional follow-up

Intervention Type: OTHER

Eligibility Criteria

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

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

Sponsors

Dr Alexis MECHULAN

UNKNOWN

Sponsor Role: collaborator

Ramsay Générale de Santé

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexis MECHULAN

Role: PRINCIPAL_INVESTIGATOR

CRRIC Clairval Hospital

Locations

CRRIC Clairval Interventional Rhythmology Research Centre Clairval Private Hospital

Marseille, PACA, France

Site Status: RECRUITING

Countries

France

Central Contacts

Jean Francois OUDET

Role: CONTACT

jf.oudet@ecten.eu

+33683346567 ext. +33683346567

Marie Barba

Role: CONTACT

mh.barba@ecten.eu

+330664888704 ext. +33683346567

Facility Contacts

Alexis Mechulan

Role: primary

33491171660

Other Identifiers

2017-A01813-50

Identifier Type: -

Identifier Source: org_study_id