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NCT05870306Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 6 May 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
105 (estimated)
First submitted
3 May 2023
Start date
1 Jan 2021
Primary completion date
1 Jan 2023
Lead sponsor
Instituto de investigación e innovación biomédica de Cádiz
NCT number
NCT05870306

What you commit to

  • Study type: Interventional
  • Planned participants: 105
  • From 1 Jan 2021 to the primary completion date, 1 Jan 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patients with severe structural cardiac disease (severe mitral regurgitation, dilated cardiomyopathy, hypertrophy cardiomyopathy, other severe valvular heart diseases)

Lab values

  • Patients with the serum creatinine \>3.5 mg/dL or creatinine clearance rate \<30 mL/min;

Other

  • Patients with left atrial size ≥55 mm (2-dimensional echocardiography, parasternal long-axis view)
  • Patients with life expectancy \<12 months;
  • Medical, geographical and social factors that make study participation impractical, and inability to give written informed consent. Patient's refusal to participate in the study.

Who the study is looking for

  • Age \> 18 years.
  • Patients undergoing a first-time ablation procedure for AF.
  • Patients with persistent or long-lasting AF; persistent AF will be defined as a sustained episode lasting \>7 days and \<1 year; long-lasting persistent AF will be \>1 year and \<3 years
  • Patients with PxAF; PxAF will be defined as a sustained episode lasting \<7 days;
  • Patients who must be willing and able to comply with all periablation and follow-up requirements
  • Patients with AF who will accept the procedure of ablation
  • Patients who signed the written informed consent for the study
  • Patients who can endure the required follow-up.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
F. para la Gestión de la Inv. Biomédica de Cádiz Ríos
Coordinator of this site? Confirm its status
CadizSpainUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.