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

NCT05870306 | Active Not Recruiting

• 1 other identifier: SCA-AF 1230-N-20
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Atrial Fibrillation, Persistent

Keywords

Atrial fibrillation; Functional mapping; Hidden slow conduction

Outcome Measures

Primary Outcomes (1)

• Number of patients with lower burden of atrial fibrillation during follow-up comparing both arms

  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.

  This outcome will be analyzed during the last 8 months of the project

Secondary Outcomes (1)

• Number of Participants With Treatment-Related Adverse Events

  This outcome will be analyzed during the recruitment period, starting on the 9th month with a duration of 20 months

Study Arms (2)

PVI alone

OTHER

High-density voltage mapping using a multipolar catheter (PentaRay or OctaRay, Biosense Webster, Diamond Bar, CA, USA) will be performed during AF. PVI will be performed with the standard protocol. If needed electrical cardioversion will be performed after PVI ablation. A 10-minute waiting period after isolation of each ipsilateral PV pair was applied to assess for acute reconnections. Additional RF applications were performed if needed at reconnection sites until PVI was achieved.

Procedure: pulmonary vein isolation

PVI PLUS HSC ABLATION

EXPERIMENTAL

After standard PVI isolation point-by point ablation targeting HSC-EGMs will be performed. HSC-EGMs with a distance less than 5 mm between them will be addressed with a single application. The ablation index will be defined based on the LA wall thickness (LAWT) at the location of the HSC-EGM: LAWT \< 1mm: 300 f, LAWT 1-2 mm: 350 f, LAWT 2-3 mm: 400 f and LAWT \>3 mm: 450 f. This is the experimental intervention added to pulmonary veins isolation. This intervention, in terms of risks, is superimposable to the ablation of CFAEs or rotational activity, which are stablished techniques for PsAF catheter ablation

Procedure: pulmonary vein isolation and targeted radiofrequency ablation

Interventions

pulmonary vein isolation and targeted radiofrequency ablation PROCEDURE

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

PVI PLUS HSC ABLATION

pulmonary vein isolation PROCEDURE

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

PVI alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with left atrial size ≥55 mm (2-dimensional echocardiography, parasternal long-axis view)
• Patients with severe structural cardiac disease (severe mitral regurgitation, dilated cardiomyopathy, hypertrophy cardiomyopathy, other severe valvular heart diseases)
• Patients with the serum creatinine \>3.5 mg/dL or creatinine clearance rate \<30 mL/min;
• 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.

Sponsors & Collaborators

• Instituto de investigación e innovación biomédica de Cádiz: lead

Study Sites (1)

F. para la Gestión de la Inv. Biomédica de Cádiz Ríos

Cadiz, 11009, Spain

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Juan Fernandez-Armenta, PhD MD

  Instituto de investigación e innovación biomédica de Cádiz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD MD

Model Details: 105 patients undergoing a first-time ablation procedure for AF will be consecutively enrolled and randomized on a 1:1 basis to PVI alone vs PVI plus slow conduction ablation. An enrollment log with all the patients included in the study, even drops out, will be collected. Data will be collected at enrollment, baseline and at three, six and 12-month follow-up visit.

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: May 23, 2023
• Study Start: January 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: June 1, 2025
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: This information will be available from the beginning of the recruitment, at the 9th month of the project with a duration of three years.
• Access Criteria: All participants in this study will get a login and password to a centralized database

Locations

ES (1)