NCT05870306

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

Active, enrolled NA Last updated 6 May 2025

What this trial tests

NA trial testing pulmonary vein isolation and targeted radiofrequency ablation in Atrial Fibrillation, Persistent in 105 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 January 2021

Primary endpoint
1 January 2023

1 June 2025

Quick facts

Lead sponsor	Instituto de investigación e innovación biomédica de Cádiz
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	105
Start date	1 January 2021
Primary completion	1 January 2023
Estimated completion	1 June 2025
Sites	1 location across Spain

Drugs / interventions tested

• pulmonary vein isolation and targeted radiofrequency ablation
• pulmonary vein isolation

Conditions studied

• Atrial Fibrillation, Persistent — all drugs for Atrial Fibrillation, Persistent →

Sponsor

Instituto de investigación e innovación biomédica de Cádiz — full company profile →

Who can join

18 and older, any sex, with Atrial Fibrillation, Persistent. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.