National Registry of Cardioneuroablation in Recurrent Reflex Syncope
- Conditions
- Syncope, VasovagalHeart ArrestBradycardia
- Interventions
- Procedure: Cardioneuroablation
- Registration Number
- NCT06159764
- Lead Sponsor
- University Hospital, Bordeaux
- Brief Summary
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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cardioneuroablation Cardioneuroablation Cardioneuroablation
- Primary Outcome Measures
Name Time Method Recurrence of vasovagal syncope 12 months Number of patients with recurrence
- Secondary Outcome Measures
Name Time Method Recurrence of vasovagal syncope in different subgroups 12 months Number of patients with recurrence
Efficacy of cardioneuroablation procedure 12 months Number of asystolic pauses
prevalence of post-ablation pre-syncopal events 12 months Number of post-ablation pre-syncopal events
correlation between ablation sites and epicardial fat pads 12 months spatial correlation between ablation sites and epicardial fat pads
Quality of life of post-ablated patients (Score 1) 12 months ISQoL score (Impact of syncope on quality of life) (0-55, lower scores indicate less impact of syncope on HRQoL \[better\]
Quality of life of post-ablated patients (Score 2) 12 months SFSQ score (Syncope Functional Status HR-QoL Questionnaire) (0-100, lower scores indicate less impact of syncope \[better\])
Assessment of technical learning curve by centre 12 months procedure time
Trial Locations
- Locations (12)
Hôpital Louis Pradel
🇫🇷Bron, France
CHU Clermont-Ferrand
🇫🇷Clermont-Ferrand, France
CHU Lille
🇫🇷Lille, France
Hôpital de la Timone
🇫🇷Marseille, France
Clinique du Millénaire
🇫🇷Montpellier, France
Hôpital Pitié-Salpêtriére
🇫🇷Paris, France
Hôpital européen Georges Pompidou
🇫🇷Paris, France
CHR Pontchaillou
🇫🇷Rennes, France
Centre cardiologique du Nord
🇫🇷Saint-Denis, France
Clinique Pasteur
🇫🇷Toulouse, France
CHU de Toulouse
🇫🇷Toulouse, France
Hôpital Haut-Lévèque
🇫🇷Pessac, France