National Registry of Cardioneuroablation in Recurrent Reflex Syncope

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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National Registry of Cardioneuroablation in Recurrent Reflex Syncope

Conditions
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Syncope, Vasovagal, Bradycardia, Heart Arrest

Intervention / Treatment
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* Procedure: Cardioneuroablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 or more Recurrent vasovagal syncope (≥2 episodes during the last year) with an asystolic component (≥3 second pause) recorded during a spontaneous episode. The asystole can be related to sinus arrest or paroxysmal AV block. Scheduled cardioneuroablation procedure Estimated residual battery life ≥ 1 year. Patient affiliated to or beneficiary of national health security scheme. Patient who have received an information notice and has not objected to the use of their data in the registry. Exclusion Criteria: Contraindication to anticoagulation therapy: major bleeding, risk of major bleeding, severe hepatic disease Contraindication to cardiac CT: contrast medium allergies Intracardiac thrombus Patient detained by judicial or administrative decision.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cardioneuroablation<br>Cardioneuroablation | Procedure: Cardioneuroablation<br>* radiofrequency ablation to destroy cardiac ganglionated plexi located in epicardial fat pads around the atrias<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of vasovagal syncope | Number of patients with recurrence | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of vasovagal syncope in different subgroups | Number of patients with recurrence | 12 months | 
| Efficacy of cardioneuroablation procedure | Number of asystolic pauses | 12 months | 
| prevalence of post-ablation pre-syncopal events | Number of post-ablation pre-syncopal events | 12 months | 
| correlation between ablation sites and epicardial fat pads | spatial correlation between ablation sites and epicardial fat pads | 12 months | 
| Quality of life of post-ablated patients | EQ-5D-5L score | 12 months | 
| Assessment of technical learning curve by centre | procedure time | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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registry, cardioneuroablation, vasovagal syncope