Actively Recruiting
National Registry of Cardioneuroablation in Recurrent Reflex Syncope
Led by University Hospital, Bordeaux · Updated on 2025-06-17
50
Participants Needed
14
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are collecting data from multiple centers in France to study cardioneuroablation as a treatment for patients with recurrent vasovagal syncope caused by strong cardioinhibitory effects. This observational registry aims to evaluate success rates, compare different techniques, and support institutions in establishing their own cardioneuroablation programs. Important questions include the procedure's success, patient benefit, target sites for ablation, methods for identifying fat pads, and long-term effects. The study focuses on cardioneuroablation, a procedure using radiofrequency ablation to destroy cardiac ganglionated plexi in epicardial fat pads around the atria. Patients with recurrent vasovagal syncope who are scheduled for this procedure will be included. The registry collects data on the recurrence of syncope, efficacy of the procedure, post-ablation symptoms, correlation with ablation sites, patient quality of life, and technical learning curves at participating centers. Participants will be monitored for 12 months to track recurrence of vasovagal syncope and other outcomes. Data collection includes clinical history, procedure details, and follow-up assessments on quality of life and symptoms. The study helps to characterize patient outcomes and improve technical approaches. Participation involves no experimental treatment beyond the scheduled procedure, with data gathered during routine care and follow-up visits.
CONDITIONS
Brief Title
National Registry of Cardioneuroablation in Recurrent Reflex Syncope
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 or more
- Recurrent vasovagal syncope (2 or more episodes in the last year) with an asystolic pause of 3 seconds or more recorded during a spontaneous episode
- Scheduled for cardioneuroablation procedure
- Estimated residual battery life of 1 year or more
- Affiliated to or beneficiary of national health security scheme
- Provided informed consent without objection to data use in registry
You will not qualify if you...
- Contraindication to anticoagulation therapy such as major bleeding, risk of major bleeding, or severe hepatic disease
- Contraindication to cardiac CT such as contrast medium allergies
- Presence of intracardiac thrombus
- Patient detained by judicial or administrative decision
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of procedure
Participants undergo cardioneuroablation, a procedure using radiofrequency ablation to destroy cardiac ganglionated plexi located in epicardial fat pads around the atrias.
1 visit (in-person)
Duration - 12 months
Participants are observed for recurrence of vasovagal syncope and other outcomes after the cardioneuroablation procedure.
Regular follow-up visits over 12 months
Trial Site Locations
Total: 14 locations
1
Hôpital Louis Pradel
Bron, France, 69500
Actively Recruiting
2
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63000
Actively Recruiting
3
CHU Lille
Lille, France, 59000
Not Yet Recruiting
4
Hôpital de la Timone
Marseille, France, 13385
Actively Recruiting
5
CHU de Montpellier
Montpellier, France, 34295
Not Yet Recruiting
6
Clinique du Millénaire
Montpellier, France, 34960
Actively Recruiting
7
Hôpital Pitié-Salpêtriére
Paris, France, 75013
Actively Recruiting
8
Hôpital européen Georges Pompidou
Paris, France, 75908
Actively Recruiting
9
Hôpital Haut-Lévèque
Pessac, France, 33604
Actively Recruiting
10
CHR Pontchaillou
Rennes, France, 35033
Actively Recruiting
11
Centre cardiologique du Nord
Saint-Denis, France, 93200
Actively Recruiting
12
Institut ARNAULT TZANCK
Saint-Laurent-du-Var, France, 06700
Not Yet Recruiting
13
Clinique Pasteur
Toulouse, France, 31076
Actively Recruiting
14
CHU de Toulouse
Toulouse, France, 31400
Actively Recruiting
Research Team
J
Josselin DUCHATEAU
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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