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

NCT03966976 | Unknown Phase 4

• 1 other identifier: 2017-A01813-50
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Vitaphone Arm

EXPERIMENTAL

Follow-up via VITAPHONE in addition to conventional monitoring.

Device: ECG monitoring & record

Conventional Arm

ACTIVE COMPARATOR

Conventional follow-up

Other: Conventional follow-up

Interventions

ECG monitoring & record 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.

Vitaphone Arm

Conventional follow-up OTHER

Conventional follow-up

Conventional Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ramsay Générale de Santé: lead
• Dr Alexis MECHULAN: collaborator

Study Sites (1)

CRRIC Clairval Interventional Rhythmology Research Centre Clairval Private Hospital

Marseille, PACA, 13273, France

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Records

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Alexis MECHULAN

  CRRIC Clairval Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean Francois OUDET

CONTACT

+33683346567; jf.oudet@ecten.eu

Marie Barba

CONTACT

+330664888704; mh.barba@ecten.eu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: May 29, 2019
• Study Start: March 15, 2018
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: May 29, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)