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Atrial Fibrillation, PersistentVOLT-AFNCT04832646

VOLTage Mapping in Atrial Fibrillation

An observational study of Atrial Fibrillation, Persistent, run by Central Hospital, Nancy, France at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

The purpose of this study is to retrospectively analyze electroanatomical data collected during persistent atrial fibrillation ablation procedures, combined with pre-ablation cardiac CT data, in order to: define a new method for quantifying left atrial voltage in atrial fibrillation via a total energy map instead of a… Read more about this study

Who is it for?
Any age
Conditions the study is for
Atrial Fibrillation, Persistent
What is being tested?
atrial fibrillation ablation
Type of treatment
Surgery or procedure
How many people
30 participants
Where
1 siteFrance
Study dates
1 Apr 2021to 1 Apr 2022
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients admitted for a procedure in the interventional electrophysiology department of the CHRU de Nancy for AF ablation between March 2019 and March 2021, for whom electroanatomical and scannographic data are available

Who may be able to join

  • Persistant Atrial fibrillation ablation
  • Voltage map in sinus rhythm and in atrial fibrillation
  • Cardiac CT scan performed before ablation

Who cannot join

  • Incomplete data, poor quality ECG recordings.

Trial locations and contacts

1 site in 1 country.

Charles Guenancia, MD, PhD contact

+33684693094

charles.guenancia@chu-dijon.fr

France1 site, 1 recruiting
  • University Hospital of Nancy

    Vandœuvre-lès-Nancy, 54500

    Christian De Chillou, MD, PhD

    Recruiting

Other trials in France

About this study

The purpose of this study is to retrospectively analyze electroanatomical data collected during persistent atrial fibrillation ablation procedures, combined with pre-ablation cardiac CT data, in order to:

  • define a new method for quantifying left atrial voltage in atrial fibrillation via a total energy map instead of a peak-to-peak amplitude map
  • confirm the association between epicardial fat localization and atrial conduction slowing
Read the detailed description

Background:

Atrial fibrillation (AF) is the most common arrhythmia, with an estimated prevalence in 2010 of 33.5 million people (3% of the world population). It is now estimated that 1 in 4 middle-aged adults in Europe and the United States will develop AF in their lifetime. Of course, the aging of the population is considered one of the major explanations for this pandemic phenomenon, as well as the ever-increasing prevalence of overweight and obesity. Complications related to this arrhythmia are numerous and frequent, with thromboembolic events having a major impact on morbidity. Thus, it is estimated that AF is responsible for a quarter of ischemic strokes and increases the risk of stroke fivefold. At the same time, there is an increased risk of long-term heart failure, which is responsible for excess mortality. Finally, patients with AF frequently have an impaired quality of life and a higher rate of hospitalization than patients in sinus rhythm (10 to 40% of patients with AF are hospitalized at least once a year). An association between AF and cognitive decline and risk of vascular dementia (even in patients treated with anticoagulants) has also been described. Depending on the temporality of AF, it is referred to as paroxysmal, persistent, or permanent AF.

Endocavitary ablation for the treatment of atrial fibrillation was first described by the Bordeaux team of Prof. Michel Haïssaguerre in the early 1990s, who demonstrated the role of electrical discharges from the pulmonary veins in the initiation of (paroxysmal) AF. The following years therefore saw the development of tools to electrically isolate the pulmonary veins from the left atrium, and then to try to identify and treat additional pathological areas in the atria for more advanced (persistent) forms of AF. The advent of three-dimensional modeling technologies has made it possible to develop intracardiac navigation systems to guide AF ablation in 3D, while limiting fluoroscopy time for the patient and staff.

In persistent AF, unlike paroxysmal AF, the technique used and the ablation targets are less codified, with success rates lower than those obtained in paroxysmal AF. Indeed, unlike paroxysmal AF, the pathophysiology of which is well understood, there is no unicist consensus theory for persistent AF. Based on the hypothesis of the predominance of the substrate over the pulmonary venous trigger in the self-maintenance of persistent AF, teams have highlighted the major role of left atrial fibrosis in this pathology, which is the cause of conduction heterogeneity in the left atrium. Work to elucidate the triggers of this fibrotic disease emphasizes the key role of periatrial epicardial fat, which secretes pro-fibrotic mediators and deregulates the atrial ganglionic plexi. An association has also been made between epicardial fat volume and the incidence and maintenance of atrial fibrillation. In addition, recent work demonstrates that the peri-atrial adipocyte environment modulates not only fibrosis but also the conductive properties of atrial cells.

During endocavitary ablation of atrial fibrillation, multi-electrode diagnostic catheters allow precise electroanatomical reconstruction of the left atrium, quantifying its geometry but also the local electrical signals (electrograms), in terms of amplitude (voltage map) and temporality relative to a reference (activation map). It is therefore theoretically possible to build a map of conduction velocities in sinus rhythm or electroentrainment in the atrium, by calculating the velocity and vector of electrical depolarization between each electrogram. In parallel, before any AF ablation, an injected cardiac CT scan is performed for three-dimensional atrial reconstruction. This scan also allows the quantification of the atrial epicardial fat in terms of volume and density. We therefore want to develop an algorithm allowing the construction of a map of velocities in sinus rhythm, fused to the three-dimensional reconstruction of the location of the atrial epicardial fat.

Being tested
atrial fibrillation ablation
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • atrial fibrillation ablationProcedure or surgery

    persistent atrial fibrillation ablation with both AF and sinus rhythm map available

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. correlation between voltage map in sinus rhythm and the new voltage map in atrial fibrillation using total energy calculation

    Measured: through study completion, an average of 1 year

Secondary outcomes (1)
  1. correlation between atrial epicardial fat deposits and atrial conduction velocities slowing

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2021
  2. Study start1 Apr 2021
  3. Primary completion1 Apr 2022 (estimated)
  4. Study completion1 Apr 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04832646
Sponsor's protocol ID
2020PI262
Acronym
VOLT-AF
Status last verified
Apr 2021
First submitted
2 Apr 2021
Last updated
6 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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