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

Primary Purpose

Atrial Fibrillation

Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
ECG monitoring & record
Conventional follow-up
Sponsored by
Ramsay Générale de Santé
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CRRIC Clairval Interventional Rhythmology Research Centre Clairval Private HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vitaphone Arm

Conventional Arm

Arm Description

Follow-up via VITAPHONE in addition to conventional monitoring.

Conventional follow-up

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 28, 2019
Last Updated
May 28, 2019
Sponsor
Ramsay Générale de Santé
Collaborators
Dr Alexis MECHULAN
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1. Study Identification

Unique Protocol Identification Number
NCT03966976
Brief Title
Comparison Between "Conventional Monitoring" Versus "Monitoring Via Vitaphone" in the Detection of Post Ablation Atrial Arrhythmias of Paroxysmal Atrial Fibrillation
Acronym
VITAPHONE
Official Title
Comparison Between "Conventional Monitoring" Versus "Monitoring Via Vitaphone" in the Detection of Post Ablation Atrial Arrhythmias of Paroxysmal Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 15, 2018 (Actual)
Primary Completion Date
September 30, 2020 (Anticipated)
Study Completion Date
September 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ramsay Générale de Santé
Collaborators
Dr Alexis MECHULAN

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vitaphone Arm
Arm Type
Experimental
Arm Description
Follow-up via VITAPHONE in addition to conventional monitoring.
Arm Title
Conventional Arm
Arm Type
Active Comparator
Arm Description
Conventional follow-up
Intervention Type
Device
Intervention Name(s)
ECG monitoring & record
Intervention Description
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
Other
Intervention Name(s)
Conventional follow-up
Intervention Description
Conventional follow-up
Primary Outcome Measure Information:
Title
Recurrence rate of AF between 3 and 6 months
Description
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.
Time Frame
3 to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean Francois OUDET
Phone
+33683346567
Ext
+33683346567
Email
jf.oudet@ecten.eu
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Barba
Phone
+330664888704
Ext
+33683346567
Email
mh.barba@ecten.eu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexis MECHULAN
Organizational Affiliation
CRRIC Clairval Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CRRIC Clairval Interventional Rhythmology Research Centre Clairval Private Hospital
City
Marseille
State/Province
Paca
ZIP/Postal Code
13273
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexis Mechulan
Phone
33491171660

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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