Registry for cardioneuroablation in patients with recurrent vasovagal syncope

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This registry collects data on the effectiveness of cardioneuroablation for treating recurrent vasovagal syncope across multiple centers in France. The study aims to evaluate success rates, compare different techniques, and assist institutions in establishing their own cardioneuroablation programs. By utilizing radiofrequency ablation to target cardiac ganglionated plexi, the registry seeks to answer key questions regarding patient selection, optimal targeting of fat pads, and long-term outcomes of the procedure. The multicenter approach allows for a comprehensive analysis at minimal cost.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hôpital Louis Pradel
  Bron, France Recruiting
• CHU Clermont-Ferrand
  Clermont-Ferrand, France Recruiting
• Hôpital de la Timone
  Marseille, France Recruiting
• Clinique du Millénaire
  Montpellier, France Recruiting
• Hôpital Pitié-Salpêtriére
  Paris, France Recruiting
• Hôpital européen Georges Pompidou
  Paris, France Recruiting

Study contacts

• Principal investigator: Josselin DUCHATEAU — University Hospital, Bordeaux
• Study coordinator: Josselin DUCHATEAU
• Email: josselin.duchateau@chu-bordeaux.fr
• Phone: +33 5 57 65 64 71

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.