RecruitingNot ApplicableNCT06291506

SUbstrate Ablation in Persistent Atrial Fibrillation for Elimination of Recurrences (SUPAFER).

: SUbstrate Ablation in Persistent Atrial Fibrillation for Elimination of Recurrences (SUPAFER): a Multicentre Randomized Clinical Trial to Assess Pulmonary Vein Isolation Alone or Combined With Linear Ablation.


Sponsor

Hospital Universitario La Paz

Enrollment

176 participants

Start Date

May 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Antecedents: electrical isolation of pulmonary veins is the standard treatment for patients with atrial fibrillation. However, its efficacy is lower in persistent and chronic forms of this arrhythmia compared to paroxysmal atrial fibrillation. Many complementary techniques have been proposed, that added to pulmonary veins isolation, may reduce the recurrence rate of atrial fibrillation. However, none of them has obtained consistent results. Linear ablation aims to parcellate and modify the left atrial substrate responsible for atrial fibrillation maintenance. Previous studies have offered contradictory results using linear ablation. Methods: SUPAFER is a multicenter, 1:1 randomized clinical trial that compares the efficacy of pulmonary veins isolation alone vs pulmonary vein isolation plus an specific protocol of left atrial linear ablation. Contrary to previous studies, the specific SUPAFER linear ablation is systematic, homogeneous and target atrial areas that have not been systematically ablated in previous trials. The trial aims at demonstrating the superiority of the combined ablative approach during 1-year follow-up. Daily transtelephonic ECG samples a 30 days continuous ECG monitoring are used to maximize de detection of recurrences, even asymptomatic.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (called SUPAFER) is comparing two approaches to cardiac ablation — a procedure that uses heat or cold energy to eliminate abnormal electrical signals in the heart — for people with persistent atrial fibrillation (AF), a condition where the heart beats irregularly for a week or more. The study tests whether treating additional areas of the heart (substrate ablation) beyond the standard approach reduces AF recurrence. **You may be eligible if...** - You are 18 or older with persistent AF (lasting more than 1 week) or long-lasting persistent AF (more than 1 year), confirmed by ECG - Your AF is symptomatic, has not responded to medication, or causes complications like heart failure or weakened heart muscle - You prefer ablation over ongoing medication **You may NOT be eligible if...** - Your AF has a treatable underlying cause - You have had previous ablation procedures on the pulmonary veins or left atrium - You have had recent heart surgery, heart attack, or a stroke within the past few months - You have a blood clot in the heart Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERRadiofrequency ablation of heart atrial tissue.

Ablation with radiofrequency, advances techniques: contact force-guided, improved tissue temperature sensors, automark algorithms.


Locations(1)

La Paz University Hospital - IdiPaz

Madrid, Spain

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NCT06291506


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