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

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.

Conditions

• Atrial Fibrillation, Persistent

Interventions

PROCEDURE

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

PROCEDURE

pulmonary vein isolation

Radiofrequency will be delivered around the left atrial ostia to isolate the veins.

Sponsors & Collaborators

• Instituto de investigación e innovación biomédica de Cádiz

  lead OTHER

Principal Investigators

• Juan Fernandez-Armenta, PhD MD · Instituto de investigación e innovación biomédica de Cádiz

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-01

Primary Completion

2023-01-01

Completion

2025-06-01

Countries

• Spain

Study Locations