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Набор скоро начнётся NCT07162740

Implantable Loop Recorder and Cardioneuroblation

— Наблюдательное Reflex Syncope

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Right atrial ablation, Bi-atrial ablation.
Кому может быть актуально
Состояния в реестре: Reflex Syncope. Базовые параметры: 18 лет — 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Comparative Study of Right Atrial Versus Bi-atrial Cardioneuroablation of Asystolic Reflex Syncope Verified by Implantable Loop Recorder

Обзор

The study aims to determine which method of vagal ganglia ablation is most effective in preventing recurrences of reflex asystole syncope. Currently, some centers perform ablation only in the right atrium, others in both atria (biatrial). There are no comparative studies between the two procedures

Подробное описание

Cardioneuroablation (CNA) therapy for reflex asystole syncope is becoming increasingly popular. The best method of CNA is debated, with no studies comparing the syncopal recurrence rates of right atrium ablation versus bi-atrial ablation. Evaluating the clinical efficacy of CNA is challenging due to symptom variability, intermittent presentation, complex pathophysiology, and different treatment options. The difficulty of obtaining precise follow-up data in patients with intermittent symptoms is well known. With ILR, more objective tracking can be achieved.

The aim of the study is to verify the efficacy of CNA on the reduction of the asystole reflex documented by continuous monitoring by ILR in patients undergoing right atrial ablation compared to bi-atrial ablation

Вмешательства

  • Процедура Right atrial ablation
    Eligible patients receive the implantation of a LuxDx® ILR and are monitored for one month by means of the Latitude Clarity data management system of the device. The usual practice of the centres is unchanged. According to their usual practice, the centre is assigned to right atrial ablation. The patients receive a right atrial procedure accordingly. As per pragmatic design, cross-over are permitted according to investigator judgment. The ablation methods and techniques are left to investigator'
  • Процедура Bi-atrial ablation
    Eligible patients receive the implantation of a LuxDx® ILR and are monitored for one month by means of the Latitude Clarity data management system of the device. The usual practice of the centres is unchanged. According to their usual practice, the centre is assigned to bi-atrial ablation. The patients receive a bi-atrial procedure accordingly. As per pragmatic design, cross-over are permitted according to investigator judgment. The ablation methods and techniques are left to investigator's deci

Первичные конечные точки

  • Mounthly frequency of asystolic episodes >3 sec [Срок оценки: through study completion, an average of 1 year]
  • Freedom from ablation-related complications [Срок оценки: through study completion, an average of 1 year]
Вторичные конечные точки (3)
  • Burden of syncopal episodes [Срок оценки: through study completion, an average of 1 year]
  • heart rate (HR) and heart rate variability (HRV) [Срок оценки: through study completion, an average of 1 year]
  • Time to first asystolic and syncope recurrence [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Критерии включения

  • Age 18 to 60 years
  • Clinical diagnosis of reflex syncope as per class I criteria of the ESC guidelines
  • History of recurrent severe syncopes (≥2 in the last year or ≥3 in the last 2 years), significantly affecting the quality of life, nonresponding to lifestyle measures.
  • Documentation by means of prolonged ECG monitoring of an asystolic pause >6 sec or of an asystolic syncope >3 sec and/or an asystolic syncope induced during tilt testing (Vasis 2B form).

Критерии исключения

  • Intrinsic sinus dysfunction or atrioventricular node disease.
  • Constitutional hypotension and orthostatic intolerance syndromes
  • Overt structural heart disease
  • Alternative diagnoses of syncope
  • Pregnancy or breastfeeding

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 1 центр
  • IRCCS Istituto Auxologico Italiano — Milan

Публикации

  • Kulakowski P, Baran J, Sikorska A, Krynski T, Niedzwiedz M, Soszynska M, Piotrowski R. Cardioneuroablation for reflex asystolic syncope: Mid-term safety, efficacy, and patient's acceptance. Heart Rhythm. 2024 Mar;21(3):282-291. doi: 10.1016/j.hrthm.2023.11.022. Epub 2023 Nov 29. PMID 38036236
  • Calo L, Rebecchi M, De Ruvo E, Giamundo D, Sette A, Tomaino M, Hunteruber M, Bottoni N, Iori M, Donateo P, Maggi R, Del Rosso A, Rafanelli M, Russo V, Strano S, Brignole M. Right atrial cardioneuroablation of asystolic reflex syncope. Heart Rhythm. 2025 Oct;22(10):e951-e958. doi: 10.1016/j.hrthm.2025.05.038. Epub 2025 May 22. PMID 40412604
  • Aksu T, Brignole M, Calo L, Debruyne P, Di Biase L, Deharo JC, Fanciulli A, Fedorowski A, Kulakowski P, Morillo C, Moya A, Piotrowski R, Stec S, Sutton R, van Dijk JG, Wichterle D, Tse HF, Yao Y, Sheldon RS, Vaseghi M, Pachon JC, Scanavacca M, Meyer C, Amin R, Gupta D, Magnano M, Malik V, Schauerte P, Shen WK, Acosta JCZ. Cardioneuroablation for the treatment of reflex syncope and functional brady PMID 39082698

Идентификаторы

NCT: NCT07162740 · ILR-CNA

Первоисточники (государственные реестры)

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