Syncope, Vasovagal, Bradycardia, Heart Arrest
Conditions
Keywords
cardioneuroablation, vasovagal syncope, registry
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
Interventions
PROCEDURECardioneuroablation
radiofrequency ablation to destroy cardiac ganglionated plexi located in epicardial fat pads around the atrias
Sponsors
University Hospital, Bordeaux
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of vasovagal syncope | 12 months | Number of patients with recurrence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of cardioneuroablation procedure | 12 months | Number of asystolic pauses |
| prevalence of post-ablation pre-syncopal events | 12 months | Number of post-ablation pre-syncopal events |
| correlation between ablation sites and epicardial fat pads | 12 months | spatial correlation between ablation sites and epicardial fat pads |
| Recurrence of vasovagal syncope in different subgroups | 12 months | Number of patients with recurrence |
| Quality of life of post-ablated patients (Score 2) | 12 months | SFSQ score (Syncope Functional Status HR-QoL Questionnaire) (0-100, lower scores indicate less impact of syncope \[better\]) |
| Assessment of technical learning curve by centre | 12 months | procedure time |
| Quality of life of post-ablated patients (Score 1) | 12 months | ISQoL score (Impact of syncope on quality of life) (0-55, lower scores indicate less impact of syncope on HRQoL \[better\] |
Countries
France
Contacts
Primary ContactJosselin DUCHATEAU
Outcome results
None listed