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.
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
- Are there results?
- None posted in the registry
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.
France1 site, 1 recruiting
- Recruiting
University Hospital of Nancy
Vandœuvre-lès-Nancy, 54500
Christian De Chillou, MD, PhD
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.
- Conditions
- Atrial Fibrillation, Persistent
- 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.
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)
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.
- First posted6 Apr 2021
- Study start1 Apr 2021
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation, PersistentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GUENANCIA Charles, Central Hospital, Nancy, France
- Investigators
- Charles GUENANCIA, MD, PhD, Principal investigator, CHRU Nancy
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VOLTage Mapping in Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04832646
- Acronym / sponsor ID
- VOLT-AF / 2020PI262
- Conditions
- Atrial Fibrillation, Persistent
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 6 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (3 listed)
- Persistant Atrial fibrillation ablation
- Voltage map in sinus rhythm and in atrial fibrillation
- Cardiac CT scan performed before ablation
Key exclusion criteria (1 listed)
- Incomplete data, poor quality ECG recordings.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| atrial fibrillation ablationpersistent atrial fibrillation ablation with both AF and sinus rhythm map available | Procedure or surgery | – |
Primary outcome
correlation between voltage map in sinus rhythm and the new voltage map in atrial fibrillation using total energy calculation
Time frame: through study completion, an average of 1 year
1 secondary outcome
correlation between atrial epicardial fat deposits and atrial conduction velocities slowing
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles GUENANCIA, MD, PhD principal investigator
CHRU Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, Persistent, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charles Guenancia, MD, PhD (+33684693094, charles.guenancia@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation between voltage map in sinus rhythm and the new voltage map in atrial fibrillation using total energy calculation (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2021.