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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06159764
Other study ID # CHUBX 2022/62
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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