National Registry of Cardioneuroablation in Recurrent Reflex Syncope

Обзор

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

Подробное описание

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

Вмешательства

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

Первичные конечные точки

• Recurrence of vasovagal syncope [Срок оценки: 12 months]

Вторичные конечные точки (7)

• Recurrence of vasovagal syncope in different subgroups [Срок оценки: 12 months]
• Efficacy of cardioneuroablation procedure [Срок оценки: 12 months]
• prevalence of post-ablation pre-syncopal events [Срок оценки: 12 months]
• correlation between ablation sites and epicardial fat pads [Срок оценки: 12 months]
• Quality of life of post-ablated patients (Score 1) [Срок оценки: 12 months]
• Quality of life of post-ablated patients (Score 2) [Срок оценки: 12 months]
• Assessment of technical learning curve by centre [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 14 центров

• Hôpital Louis Pradel — Bron
• CHU Clermont-Ferrand — Clermont-Ferrand
• CHU Lille — Lille
• Hôpital de la Timone — Marseille
• CHU de Montpellier — Montpellier
• Clinique du Millénaire — Montpellier
• Hôpital Pitié-Salpêtriére — Paris
• Hôpital européen Georges Pompidou — Paris
• … и ещё 6 центров

Идентификаторы

NCT: NCT06159764 · CHUBX 2022/62

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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