National Registry of Cardioneuroablation in Recurrent Reflex Syncope

Last updated: February 25, 2025
Sponsor: University Hospital, Bordeaux
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cataplexy

Orthostatic Hypotension

Heart Defect

Treatment

Cardioneuroablation

Clinical Study ID

NCT06159764
CHUBX 2022/62
  • Ages 18-100
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients aged 18 or more

  • Recurrent vasovagal syncope (≥2 episodes during the last year) with an asystoliccomponent (≥3 second pause) recorded during a spontaneous episode. The asystole canbe 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 oftheir data in the registry.

Exclusion

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

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Cardioneuroablation
Phase:
Study Start date:
November 27, 2024
Estimated Completion Date:
January 31, 2026

Study 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

Connect with a study center

  • Hôpital Louis Pradel

    Bron, 69500
    France

    Site Not Available

  • CHU Clermont-Ferrand

    Clermont-Ferrand, 63000
    France

    Site Not Available

  • CHU Lille

    Lille, 59000
    France

    Site Not Available

  • Hôpital de la Timone

    Marseille, 13385
    France

    Site Not Available

  • Clinique du Millénaire

    Montpellier, 34960
    France

    Site Not Available

  • Hôpital Pitié-Salpêtriére

    Paris, 75013
    France

    Site Not Available

  • Hôpital européen Georges Pompidou

    Paris, 75908
    France

    Site Not Available

  • Hôpital Haut-Lévèque

    Pessac, 33604
    France

    Active - Recruiting

  • CHR Pontchaillou

    Rennes, 35033
    France

    Site Not Available

  • Centre cardiologique du Nord

    Saint-Denis, 93200
    France

    Site Not Available

  • CHU de Toulouse

    Toulouse, 31400
    France

    Site Not Available

  • Clinique Pasteur

    Toulouse, 31076
    France

    Site Not Available

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