An observational study in Syncope, Vasovagal, Bradycardia and Heart Arrest, sponsored by University Hospital, Bordeaux. Recruiting at 14 sites in France. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-06-17.
Sponsored by University Hospital, Bordeaux · Observational
This registry aims to collect patient data on cardioneuroablation for vasovagal syncope from multiple centers in France. The aim is to evaluate success rates, compare techniques and help institutions set up their own cardioneuroablation program
Cardioneuroablation is an emerging technique used to treat patients with vagally-mediated extrinsic bradycardia. It seems particularly efficient in patients with recurrent vasovagal syncope due to a strong cardioinhibitory effect. The procedure consists in using radiofrequency ablation to destroy cardiac ganglionated plexi located in epicardial fat pads around the atrias. Key questions concerning this procedure still remain unanswered: 1) What is the success rate of the procedure 2) Which patients will benefit from this technique? 3) Which fat pads should be targeted during the procedure? 4) What is the best way of identifying the location of these fat pads? 5) What are the long-term effects of this procedure? A multicenter registry seems ideal to try to answer these questions at minimal cost
88 studies on the registry are indexed under Syncope, Vasovagal; 28 are open to participants now.
This study's planned enrollment of 50 is below the median of 140 across 29 observational studies indexed under Syncope, Vasovagal.
Browse Syncope, Vasovagal studies →University Hospital, Bordeaux is the lead sponsor of 806 studies on the registry; 197 are open to participants now.
Counted across the registry records on this site, refreshed daily.
patients with vagally-mediated extrinsic bradycardia
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cardioneuroablation
Procedure: Cardioneuroablation
radiofrequency ablation to destroy cardiac ganglionated plexi located in epicardial fat pads around the atrias
Recurrence of vasovagal syncope
Number of patients with recurrence
Time frame: 12 months
Recurrence of vasovagal syncope in different subgroups
Number of patients with recurrence
Time frame: 12 months
Efficacy of cardioneuroablation procedure
Number of asystolic pauses
Time frame: 12 months
prevalence of post-ablation pre-syncopal events
Number of post-ablation pre-syncopal events
Time frame: 12 months
correlation between ablation sites and epicardial fat pads
spatial correlation between ablation sites and epicardial fat pads
Time frame: 12 months
Quality of life of post-ablated patients (Score 1)
ISQoL score (Impact of syncope on quality of life) (0-55, lower scores indicate less impact of syncope on HRQoL \[better\]
Time frame: 12 months
Quality of life of post-ablated patients (Score 2)
SFSQ score (Syncope Functional Status HR-QoL Questionnaire) (0-100, lower scores indicate less impact of syncope \[better\])
Time frame: 12 months
Assessment of technical learning curve by centre
procedure time
Time frame: 12 months
Started Nov 2024 (actual). Primary completion is estimated for Jan 2026, 14 months after the start.
How these figures are worked out, and which studies are left out of them.
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