National Registry of Cardioneuroablation in Recurrent Reflex Syncope

Bradycardia Clinical Trial

— CANVAS-R  

Official title:

National Registry of Cardioneuroablation in Recurrent Reflex Syncope

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06159764
• Other study ID #: CHUBX 2022/62
• Status: Not yet recruiting
• Start date: December 15, 2023
• Est. completion date: January 31, 2025

Study information

• Verified date: November 2023
• Source: University Hospital, Bordeaux
• Contact: Josselin DUCHATEAU
• Phone: +33 5 57 65 64 71
• Email: josselin.duchateau[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bradycardia
• Heart Arrest
• Syncope
• Syncope, Vasovagal

Intervention

Procedure:
• Cardioneuroablation
radiofrequency ablation to destroy cardiac ganglionated plexi located in epicardial fat pads around the atrias

Locations

Country	Name	City	State
France	Hôpital Haut-Lévèque	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of vasovagal syncope	Number of patients with recurrence	12 months
Secondary	Recurrence of vasovagal syncope in different subgroups	Number of patients with recurrence	12 months
Secondary	Efficacy of cardioneuroablation procedure	Number of asystolic pauses	12 months
Secondary	prevalence of post-ablation pre-syncopal events	Number of post-ablation pre-syncopal events	12 months
Secondary	correlation between ablation sites and epicardial fat pads	spatial correlation between ablation sites and epicardial fat pads	12 months
Secondary	Quality of life of post-ablated patients	EQ-5D-5L score	12 months
Secondary	Assessment of technical learning curve by centre	procedure time	12 months