Ablation guided by hierarchical heart electrical patterns to treat atrial fibrillation
Ablación de la fibrilación Cardiaca Humana Basada en Modelos de organización jerárquica de la excitación Tisular.
This project will try a targeted ablation guided by models of the heart's electrical organization to see if it reduces arrhythmias in adults with persistent atrial fibrillation or with recurrent ventricular arrhythmias not controlled by medicines.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital San Carlos, Madrid Academic / other |
| Locations | 1 site (Madrid, Madrid) |
| Trial ID | NCT07390175 on ClinicalTrials.gov |
What this trial studies
Investigators use non-invasive and invasive mapping methods to identify hierarchical domains of electrical activity (rotational zones, frequency domains, and adenosine responses) that appear to maintain arrhythmias, called DFASI/DFSI domains. Patients meeting criteria undergo targeted catheter ablation of those identified domains and are compared with control ablation procedures. The project will characterize how ablation of these domains changes the physiology and maintenance of persistent AF and will explore similar mechanisms in patients with recurrent ventricular fibrillation/tachycardia. The goal is to refine ablation strategies and translate preclinical findings into improved clinical approaches.
Who should consider this trial
Good fit: Adults over 18 with uninterrupted persistent atrial fibrillation lasting more than six months and an indication for ablation, or adults with recurrent ventricular fibrillation/ventricular tachycardia poorly controlled by medicines, are ideal candidates.
Not a fit: Patients with arrhythmias secondary to endocrine or severe systemic disease, those who cannot receive adenosine, those with contraindications to cardiac catheterization, or those unable to have implantable remote monitoring are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this targeted approach could lower arrhythmia recurrence, reduce symptoms, and decrease the need for repeat procedures compared with conventional ablation.
How similar studies have performed: Previous work by the investigators (Calvo et al., Sci Rep. 2025) reported improved clinical results and safety using this targeted approach, but larger confirmatory trials remain limited and the approach is still emerging.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Madrid, Madrid
- Hospital Clínico San Carlos — Madrid, Madrid, Spain (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.