National Registry of Cardioneuroablation in Recurrent Reflex Syncope

Recruiting

• Conditions: Syncope, Vasovagal; Heart Arrest; Bradycardia

• 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

Study Timeline

• Study First Submitted: 2023-11-28
• Study First Submitted QC: 2023-11-28
• Study First Posted: 2023-12-07
• Study Start: 2024-11-27
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-12
• Last Update Posted: 2025-06-17
• Primary Completion: 2026-01-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence of vasovagal syncope	12 months	Number of patients with recurrence

Secondary Outcome Measures

Name	Time	Method
Assessment of technical learning curve by centre	12 months	procedure time
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 \[better\])

Trial Locations

Locations (14)

CHU de Montpellier; 🇫🇷 Montpellier, France

Institut ARNAULT TZANCK; 🇫🇷 Saint-Laurent-du-Var, France

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

Hôpital Haut-Lévèque; 🇫🇷 Pessac, France

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