National Registry of Cardioneuroablation in Recurrent Reflex Syncope

University Hospital, Bordeaux50 enrolled

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

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 Type

OBSERVATIONAL

Enrollment

Conditions

Syncope, Vasovagal Bradycardia Heart Arrest

Interventions

CardioneuroablationPROCEDURE

radiofrequency ablation to destroy cardiac ganglionated plexi located in epicardial fat pads around the atrias

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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.

Locations (14)

Hôpital Louis Pradel

Bron, France

RECRUITING

CHU Clermont-Ferrand

Clermont-Ferrand, France

RECRUITING

Outcomes

Primary Outcomes

Recurrence of vasovagal syncope

Number of patients with recurrence

Time frame: 12 months

Secondary Outcomes

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

Central Contacts

Josselin DUCHATEAU

CONTACT

+33 5 57 65 64 71 josselin.duchateau@chu-bordeaux.fr

Data from ClinicalTrials.gov

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