Ablation of Human Cardiac Fibrillation Based on Models of Hierarchical Organization of Tissue Excitation

Официальное название

Ablación de la fibrilación Cardiaca Humana Basada en Modelos de organización jerárquica de la excitación Tisular.

Обзор

The mechanisms that maintain persistent atrial fibrillation (AF) in humans remain unknown. In the research project PI18/01268 funded in the previous call for Strategic Action in Health, the group has demonstrated that the hierarchical organization of (i) rotational domains, (ii) frequency domains and (iii) physiological responses to pharmacological provocation with adenosine, allow the identification of domains of high-frequency reentrant activity (hereinafter "DFASI domains") maintainers of AF. As a result, the investigators have developed non-invasive technological models and quantitative indices for the efficient localization of these domains, whose therapeutic approach through ablation has allowed to improve the clinical results of the patients studied, safely without increase in complications (Calvo D et al. Sci Rep. 2025 Dec 16;15(1):43892). Likewise, and in response to the objectives of the PI18/01268 project, the investigators have identified hierarchical organization patterns in human ventricular fibrillation (VF) that indicate the existence of universal fibrillatory mechanisms, opening the door to new therapeutic opportunities (Europace 2022;24\[11\]:1788-1799).

Подробное описание

The present research project proposes to characterize the physiology of persistent human AF after therapeutic interaction (ablation) with the "DFASI domains", exploring its impact on the dynamics and maintenance of AF in patients. The investigators propose to reveal the physiological mechanisms by which this interaction improves the clinical outcomes of our patients (Objective 1), which will allow the development of more efficient ablation strategies (Objective 2). Likewise, preclinical models developed by our group in collaboration with the National Center for Cardiovascular Research support the translation of our technological developments to the field of human VF. Therefore, in the present research project the investigators propose to explore the physiological significance of "DFSI domains" in patients with recurrent VF and the eventual development of efficient ablative therapies (Objective 3). With the proposed objectives, the project addresses the challenges posed in the diagnosis and treatment of cardiovascular diseases within the National Health System, in the context of a prevalent pathology (cardiac fibrillation) with high morbidity and mortality.

Вмешательства

• Процедура Active group ablation
  In patients in the active group, changes in fibrillation dynamics induced by CPVI and ablation of DFASI domains will be evaluated, as suggested by our preliminary results (Calvo D et al. Sci Rep. 2025 Dec 16;15(1):43892). Therefore, an experimental protocol will be carried out in which, after CPVI, each DFASI domain will be addressed sequentially. The following will be determined: a) changes in hierarchical organization levels, b) the formation of new DFASI domains; c) if AF ends after ablation,
• Процедура Control group ablation
  Therefore, an experimental protocol will be carried out in which, once the CPVI has been completed, a new acquisition of non-invasive maps will be performed to characterize the basal fibrillation dynamics and those under adenosine.

Первичные конечные точки

• Mapping for the identification of stable reentrant domains with high activation frequency in persistent AF. [Срок оценки: During procedure]
• Effects of ablation of DFSAI > 0.8 domains on fibrillation dynamics and sustainability [Срок оценки: During procedure]
• Effects of ablation of reentrat domains of human ventricular fibrillation on arrhythmia inducibility. [Срок оценки: Procedure]
• Arrhythmia burden during Follow-up [Срок оценки: 3, 6 and 12 months follow-up visits]

Критерии участия

Критерии включения

• Patients over 18 years of age with persistent AF lasting more than 6 months at the time of the experimental protocol (uninterrupted persistent AF) and clinical indication for an AF ablation procedure.

or

-Patients over 18 years of age with recurrent VF/VT and poor control with conventional pharmacological measures.

Критерии исключения

• Lack of patient consent to participate in the study.
• In patients with persistent AF, contraindication for the use of adenosine.
• AF/VF/VPT secondary to endocrine-metabolic disorders and/or severe systemic disease (thyrotoxicosis, sepsis, pulmonary thromboembolism, etc.).
• Contraindications for cardiac catheterization (e.g., intracardiac thrombus).
• Impossibility of remote monitoring using an implantable Holter monitor or implantable defibrillator.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Hospital Clínico San Carlos — Madrid

Идентификаторы

NCT: NCT07390175 · TerFib_Hyerarchy · 80/18

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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