National Registry of Cardioneuroablation in Recurrent Reflex Syncope
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cardioneuroablation.
- Who it may be relevant to
- Registry conditions: Syncope, Vasovagal, Bradycardia, Heart Arrest. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
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
Interventions
- Procedure Cardioneuroablation
radiofrequency ablation to destroy cardiac ganglionated plexi located in epicardial fat pads around the atrias
Primary outcome measures
- Recurrence of vasovagal syncope [Time frame: 12 months]
Secondary outcome measures (7)
- Recurrence of vasovagal syncope in different subgroups [Time frame: 12 months]
- Efficacy of cardioneuroablation procedure [Time frame: 12 months]
- prevalence of post-ablation pre-syncopal events [Time frame: 12 months]
- correlation between ablation sites and epicardial fat pads [Time frame: 12 months]
- Quality of life of post-ablated patients (Score 1) [Time frame: 12 months]
- Quality of life of post-ablated patients (Score 2) [Time frame: 12 months]
- Assessment of technical learning curve by centre [Time frame: 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 14 centers
- Hôpital Louis Pradel — Bron
- CHU Clermont-Ferrand — Clermont-Ferrand
- CHU Lille — Lille
- Hôpital de la Timone — Marseille
- CHU de Montpellier — Montpellier
- Clinique du Millénaire — Montpellier
- Hôpital Pitié-Salpêtriére — Paris
- Hôpital européen Georges Pompidou — Paris
- … and 6 more centers
Identifiers
NCT: NCT06159764 · CHUBX 2022/62