NCT06159764

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

14 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 7, 2023

Completed
12 months until next milestone

Study Start

First participant enrolled

November 27, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

June 17, 2025

Status Verified

June 1, 2025

Enrollment Period

1.2 years

First QC Date

November 28, 2023

Last Update Submit

June 12, 2025

Conditions

Syncope, VasovagalBradycardiaHeart Arrest

Keywords

cardioneuroablationvasovagal syncoperegistry

Outcome Measures

Primary Outcomes (1)

  • Recurrence of vasovagal syncope

    Number of patients with recurrence

    12 months

Secondary Outcomes (7)

  • Recurrence of vasovagal syncope in different subgroups

    12 months

  • Efficacy of cardioneuroablation procedure

    12 months

  • prevalence of post-ablation pre-syncopal events

    12 months

  • correlation between ablation sites and epicardial fat pads

    12 months

  • Quality of life of post-ablated patients (Score 1)

    12 months

  • +2 more secondary outcomes

Study Arms (1)

Cardioneuroablation

Cardioneuroablation

Procedure: Cardioneuroablation

Interventions

CardioneuroablationPROCEDURE

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

Cardioneuroablation

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with vagally-mediated extrinsic bradycardia

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Hôpital Louis Pradel

Bron, 69500, France

RECRUITING

CHU Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

CHU Lille

Lille, 59000, France

NOT YET RECRUITING

Hôpital de la Timone

Marseille, 13385, France

RECRUITING

CHU de Montpellier

Montpellier, 34295, France

NOT YET RECRUITING

Clinique du Millénaire

Montpellier, 34960, France

RECRUITING

Hôpital Pitié-Salpêtriére

Paris, 75013, France

RECRUITING

Hôpital européen Georges Pompidou

Paris, 75908, France

RECRUITING

Hôpital Haut-Lévèque

Pessac, 33604, France

RECRUITING

CHR Pontchaillou

Rennes, 35033, France

RECRUITING

Centre cardiologique du Nord

Saint-Denis, 93200, France

RECRUITING

Institut ARNAULT TZANCK

Saint-Laurent-du-Var, 06700, France

NOT YET RECRUITING

Clinique Pasteur

Toulouse, 31076, France

RECRUITING

CHU de Toulouse

Toulouse, 31400, France

RECRUITING

MeSH Terms

Conditions

Syncope, VasovagalBradycardiaHeart Arrest

Condition Hierarchy (Ancestors)

Orthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesSyncopeUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic Processes

Study Officials

  • Josselin DUCHATEAU

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Josselin DUCHATEAU

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2023

First Posted

December 7, 2023

Study Start

November 27, 2024

Primary Completion

January 31, 2026

Study Completion

January 31, 2026

Last Updated

June 17, 2025

Record last verified: 2025-06

Locations

FR(14)