RecruitingNot ApplicableNCT07390175

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

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

Sponsor

Hospital San Carlos, Madrid

Enrollment

78 participants

Start Date

Jan 20, 2025

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation (AF)Ablation Treatment TerFib_Hyerarchy

Summary

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying a new approach to heart ablation — a procedure that uses energy to correct abnormal heart rhythms. Researchers are using computer models of how electrical signals move through heart tissue to guide ablation more precisely for patients with persistent atrial fibrillation (AF) or dangerous ventricular arrhythmias (abnormal rhythms in the lower heart chambers). **You may be eligible if...** - You are over 18 years old - You have had persistent atrial fibrillation (AF) lasting more than 6 months and your doctor recommends ablation, OR - You have recurring dangerous ventricular arrhythmias (VF/VT) that are not well-controlled with medications **You may NOT be eligible if...** - You cannot or will not give consent - Your heart rhythm problem is caused by another medical condition (e.g., thyroid disease, severe infection, or blood clot in the lungs) - You have a blood clot inside your heart or other reasons you cannot have a catheter-based heart procedure - A monitoring implant (like a loop recorder) cannot be placed in you Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREActive 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, the termination mechanisms will be described. Once all ablation sets on the identified DFASI reentrant domains have been completed, noninvasive maps will be acquired under the effect of adenosine in order to compare fibrillatory dynamics under basal adenosine vs. post-ablation.

PROCEDUREControl 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.