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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardioneuroablation | Cardioneuroablation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardioneuroablation | Procedure | radiofrequency ablation to destroy cardiac ganglionated plexi located in epicardial fat pads around the atrias |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of vasovagal syncope | Number of patients with recurrence | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of vasovagal syncope in different subgroups | Number of patients with recurrence | 12 months |
| Efficacy of cardioneuroablation procedure | Number of asystolic pauses |
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Inclusion Criteria:
Exclusion Criteria:
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patients with vagally-mediated extrinsic bradycardia
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Josselin DUCHATEAU | Contact | +33 5 57 65 64 71 | josselin.duchateau@chu-bordeaux.fr |
| Name | Affiliation | Role |
|---|---|---|
| Josselin DUCHATEAU | University Hospital, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Louis Pradel | Recruiting | Bron | 69500 | France |
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| ID | Term |
|---|---|
| D019462 | Syncope, Vasovagal |
| D001919 | Bradycardia |
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D054971 | Orthostatic Intolerance |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 12 months |
| prevalence of post-ablation pre-syncopal events | Number of post-ablation pre-syncopal events | 12 months |
| correlation between ablation sites and epicardial fat pads | spatial correlation between ablation sites and epicardial fat pads | 12 months |
| Quality of life of post-ablated patients (Score 1) | ISQoL score (Impact of syncope on quality of life) (0-55, lower scores indicate less impact of syncope on HRQoL [better] | 12 months |
| Quality of life of post-ablated patients (Score 2) | SFSQ score (Syncope Functional Status HR-QoL Questionnaire) (0-100, lower scores indicate less impact of syncope [better]) | 12 months |
| Assessment of technical learning curve by centre | procedure time | 12 months |
| CHU Clermont-Ferrand | Recruiting | Clermont-Ferrand | 63000 | France |
|
| CHU Lille | Not yet recruiting | Lille | 59000 | France |
|
| Hôpital de la Timone | Recruiting | Marseille | 13385 | France |
|
| CHU de Montpellier | Not yet recruiting | Montpellier | 34295 | France |
|
| Clinique du Millénaire | Recruiting | Montpellier | 34960 | France |
|
| Hôpital Pitié-Salpêtriére | Recruiting | Paris | 75013 | France |
|
| Hôpital européen Georges Pompidou | Recruiting | Paris | 75908 | France |
|
| Hôpital Haut-Lévèque | Recruiting | Pessac | 33604 | France |
|
| CHR Pontchaillou | Recruiting | Rennes | 35033 | France |
|
| Centre cardiologique du Nord | Recruiting | Saint-Denis | 93200 | France |
|
| Institut ARNAULT TZANCK | Not yet recruiting | Saint-Laurent-du-Var | 06700 | France |
|
| Clinique Pasteur | Recruiting | Toulouse | 31076 | France |
|
| CHU de Toulouse | Recruiting | Toulouse | 31400 | France |
|
| D013575 | Syncope |
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |