National Registry of Cardioneuroablation in Recurrent Reflex Syncope

NCT ID: NCT06159764

Last Updated: 2025-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-27

Study Completion Date

2026-01-31

Brief Summary

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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

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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

Conditions

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Syncope, Vasovagal Bradycardia Heart Arrest

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cardioneuroablation

Cardioneuroablation

Cardioneuroablation

Intervention Type PROCEDURE

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

Interventions

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Cardioneuroablation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Josselin DUCHATEAU

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

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Hôpital Haut-Lévèque

Pessac, , France

Site Status RECRUITING

CHR Pontchaillou

Rennes, , France

Site Status RECRUITING

Hôpital Pitié-Salpêtriére

Paris, , France

Site Status RECRUITING

Hôpital européen Georges Pompidou

Paris, , France

Site Status RECRUITING

Hôpital Louis Pradel

Bron, , France

Site Status RECRUITING

CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status RECRUITING

CHU Lille

Lille, , France

Site Status NOT_YET_RECRUITING

Hôpital de la Timone

Marseille, , France

Site Status RECRUITING

CHU de Montpellier

Montpellier, , France

Site Status NOT_YET_RECRUITING

Clinique du Millénaire

Montpellier, , France

Site Status RECRUITING

Centre cardiologique du Nord

Saint-Denis, , France

Site Status RECRUITING

Institut ARNAULT TZANCK

Saint-Laurent-du-Var, , France

Site Status NOT_YET_RECRUITING

Clinique Pasteur

Toulouse, , France

Site Status RECRUITING

CHU de Toulouse

Toulouse, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Josselin DUCHATEAU

Role: CONTACT

+33 5 57 65 64 71

Facility Contacts

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Kévin GARDEY

Role: primary

Saer ABU ALRUB

Role: primary

Cédric KLEIN

Role: primary

Baptiste MAILLE

Role: primary

Mathieu GRANIER

Role: primary

Nicolas CLEMENTY

Role: primary

Nicolas BADENCO

Role: primary

Pierre BAUDINAUD

Role: primary

Josselin Duchateau

Role: primary

Raphaël MARTINS

Role: primary

William ESCANDE

Role: primary

Hugo MARCHAND

Role: primary

Quentin VOGLIMACCI

Role: primary

Philippe MAURY

Role: primary

Other Identifiers

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CHUBX 2022/62

Identifier Type: -

Identifier Source: org_study_id

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