Status:

RECRUITING

National Registry of Cardioneuroablation in Recurrent Reflex Syncope

Lead Sponsor:

University Hospital, Bordeaux

Conditions:

Syncope, Vasovagal

Bradycardia

Eligibility:

All Genders

18-100 years

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 ...

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 s...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

November 27 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

January 31 2026

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT06159764

Start Date

November 27 2024

End Date

January 31 2026

Last Update

June 17 2025

Active Locations (14)

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Page 1 of 4 (14 locations)

1

Hôpital Louis Pradel

Bron, France, 69500

2

CHU Clermont-Ferrand

Clermont-Ferrand, France, 63000

3

CHU Lille

Lille, France, 59000

4

Hôpital de la Timone

Marseille, France, 13385