Ablation of Human Cardiac Fibrillation Based on Models of Hierarchical Organization of Tissue Excitation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Active group ablation, Control group ablation.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation (AF), Ablation Treatment, TerFib_Hyerarchy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Ablación de la fibrilación Cardiaca Humana Basada en Modelos de organización jerárquica de la excitación Tisular.
Overview
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).
Detailed description
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.
Interventions
- Procedure 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, - Procedure 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.
Primary outcome measures
- Mapping for the identification of stable reentrant domains with high activation frequency in persistent AF. [Time frame: During procedure]
- Effects of ablation of DFSAI > 0.8 domains on fibrillation dynamics and sustainability [Time frame: During procedure]
- Effects of ablation of reentrat domains of human ventricular fibrillation on arrhythmia inducibility. [Time frame: Procedure]
- Arrhythmia burden during Follow-up [Time frame: 3, 6 and 12 months follow-up visits]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Hospital Clínico San Carlos — Madrid
Identifiers
NCT: NCT07390175 · TerFib_Hyerarchy · 80/18