Triple Atria Extrastimuli vs Pulmonary Vein Isolation Alone in Persistent Atrial Fibrillation

Condition(s) studied

Investigational drug(s) / intervention(s)

pulmonary vein isolation and targeted radiofrequency ablation: Radiofrequency will be delivered around the left atrial ostia to isolate the veins. Extra radiofrequency ablation will be performed on the targeted areas

pulmonary vein isolation: Radiofrequency will be delivered around the left atrial ostia to isolate the veins.

Study summary

The problem addressed in this proposal is related to the success rate in treating one of the most common arrhythmias in the Western population, atrial fibrillation (AF). Specifically, the success rate is particularly low in persistent atrial fibrillation, being up to 40% lower than the success rate for paroxysmal atrial fibrillation.

Atrial fibrillation is associated with increased mortality and morbidity (stroke, heart failure, dementia, etc.). The most effective treatment is electrical isolation of the pulmonary veins (PVI) by catheter ablation using radiofrequency or cryoablation of the atrial myocardial tissue. This ablation allows the elimination of the main initiators of the arrhythmia but may not address its maintainers, which play a significant role in persistent atrial fibrillation.

This project proposes a new approach in studying the atrial myocardial substrate for persistent fibrillation ablation. Until now, maintainers of the arrhythmia have been sought by conducting studies during atrial fibrillation. In this project, we will use short-coupled stimulation techniques during sinus rhythm and analyze the response of the atrial myocardium, attempting to unmask areas where the impulse propagates abnormally/slowly. These areas of the atrial muscle with hidden slow conduction (HSC) could generate short circuits that maintain atrial fibrillation. It would be expected that these areas would show fragmented electrograms in response to rapid electrical stimuli not visible in basal rhythm.

The study is divided into two sub-studies to be carried out over the 3-year project.

1. This study aims to test the feasibility of this new arrhythmic substrate characterization strategy, as well as observe differences between patients with paroxysmal and persistent AF and compare it with conventional fragmented electrogram analysis during AF.
2. The second sub-study will apply the knowledge acquired during the first phase regarding the characterization of electrograms-HSC, allowing for radiofrequency ablation procedures to be performed using a new substrate ablation technique consisting of the elimination of these electrograms and comparing the results with those patients who undergo conventional pulmonary vein ablation techniques.

The ultimate goal, from a global point of view, is to demonstrate that it is possible to improve the results of arrhythmia treatment by identifying and eliminating these electrograms-HSC.

Eligibility

Primary outcome measure(s)

• Number of patients with lower burden of atrial fibrillation during follow-up comparing both arms — This outcome will be analyzed during the last 8 months of the project
  It will be assessed through a 24-hour holter monitor during follow-up the burden of atrial fibrillation in both study arms. It will be evaluated whether the elimination of HSC-EGM along with PVI will improve the outcomes in Persistent AF compared to those in which only PVI is performed.

Trial sites (1)

Other trials for the same condition