A Phase 4 interventional study of ECG monitoring & record and Conventional follow-up in Atrial Fibrillation, sponsored by Ramsay Générale de Santé. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-29.
Sponsored by Ramsay Générale de Santé · Phase 4, Interventional, and Diagnostic
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.
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's planned enrollment of 20 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Ramsay Générale de Santé is the lead sponsor of 42 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Follow-up via VITAPHONE in addition to conventional monitoring.
Device: ECG monitoring & record
Conventional follow-up
Other: Conventional follow-up
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 follow-up
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.
Time frame: 3 to 6 months
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Ramsay Générale de Santé