Clinical trial NCT06159764: National Registry of Cardioneuroablation in Recurrent Reflex Syncope
Official title: National Registry of Cardioneuroablation in Recurrent Reflex Syncope
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Syncope, Vasovagal
Bradycardia
Heart Arrest
Keywords: cardioneuroablation
vasovagal syncope
registry
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2023-12-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with vagally-mediated extrinsic bradycardia

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

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 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

Eligibility criteria: 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.

Primary outcomes:
measure: Recurrence of vasovagal syncope
timeFrame: 12 months
Secondary outcomes:
measure: Recurrence of vasovagal syncope in different subgroups
timeFrame: 12 months
measure: Efficacy of cardioneuroablation procedure
timeFrame: 12 months
measure: prevalence of post-ablation pre-syncopal events
timeFrame: 12 months
measure: correlation between ablation sites and epicardial fat pads
timeFrame: 12 months
measure: Quality of life of post-ablated patients (Score 1)
timeFrame: 12 months
measure: Quality of life of post-ablated patients (Score 2)
timeFrame: 12 months
measure: Assessment of technical learning curve by centre
timeFrame: 12 months
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Louis Pradel
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Lille
country: France
facility: CHU Lille
city: Marseille
country: France
facility: Hôpital de la Timone
city: Montpellier
country: France
facility: CHU de Montpellier
city: Montpellier
country: France
facility: Clinique du Millénaire
city: Paris
country: France
facility: Hôpital Pitié-Salpêtriére
city: Paris
country: France
facility: Hôpital européen Georges Pompidou
city: Pessac
country: France
facility: Hôpital Haut-Lévèque
city: Rennes
country: France
facility: CHR Pontchaillou
city: Saint-Denis
country: France
facility: Centre cardiologique du Nord
city: Saint-Laurent-du-Var
country: France
facility: Institut ARNAULT TZANCK
city: Toulouse
country: France
facility: Clinique Pasteur
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: University Hospital, Bordeaux
name: Josselin DUCHATEAU
role: PRINCIPAL_INVESTIGATOR
References: