Actively Recruiting
Ablation of Human Cardiac Fibrillation Based on Hierarchical Models of Tissue Excitation Organization
Led by Hospital San Carlos, Madrid · Updated on 2026-02-20
78
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
H
Hospital San Carlos, Madrid
Lead Sponsor
I
Instituto de Salud Carlos III
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the mechanisms that sustain persistent atrial fibrillation (AF) and ventricular fibrillation (VF) in humans. This study focuses on understanding how specific areas of high-frequency electrical activity, called DFASI domains, maintain these heart rhythm disorders. The project aims to explore how targeting these domains with ablation therapy affects AF dynamics and clinical outcomes, and to extend these findings to improve treatment options for patients with recurrent VF. The study involves two groups: a control group receiving circumferential pulmonary vein isolation (CPVI) alone, and an active group receiving CPVI plus additional ablation targeting DFASI domains identified through non-invasive mapping. After CPVI in both groups, researchers will perform non-invasive mapping to assess fibrillation patterns, with the active group undergoing sequential ablation of the DFASI domains. Adenosine will be used to evaluate changes in fibrillation dynamics before and after ablation. Participants will undergo detailed non-invasive mapping during the procedure to identify reentrant areas with high activation frequency. Researchers will measure changes in fibrillation dynamics during and after ablation, and track arrhythmia burden over follow-up visits at 3, 6, and 12 months. The study includes safety monitoring and aims to improve understanding of fibrillation physiology and treatment effectiveness over time.
CONDITIONS
Brief Title
Ablation of Human Cardiac Fibrillation Based on Models of Hierarchical Organization of Tissue Excitation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients over 18 years old with persistent atrial fibrillation lasting more than 6 months and clinical indication for AF ablation.
- Patients over 18 years old with recurrent ventricular fibrillation or ventricular tachycardia poorly controlled by conventional medication.
You will not qualify if you...
- Lack of patient consent to participate in the study.
- Contraindication for the use of adenosine in patients with persistent AF.
- AF, VF, or VT caused by endocrine-metabolic disorders or severe systemic diseases (e.g., thyrotoxicosis, sepsis, pulmonary thromboembolism).
- Contraindications for cardiac catheterization, such as intracardiac thrombus.
- Inability to use remote monitoring devices like implantable Holter monitors or defibrillators.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - During procedure
Participants undergo ablation treatment where fibrillation dynamics are evaluated. Those in the active group receive CPVI plus ablation of DFASI domains with sequential evaluation of non-invasive maps during the procedure. Those in the control group receive CPVI only with non-invasive mapping before and after ablation.
1 procedure visit (in-person)
Duration - Up to 12 months
Participants are monitored for arrhythmia burden and clinical outcomes after ablation at scheduled follow-up visits.
3 visits (at 3, 6, and 12 months post-procedure)
Trial Site Locations
Total: 1 location
1
Hospital Clínico San Carlos
Madrid, Madrid, Spain, 28040
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here