RecruitingNot ApplicableNCT06199180

Pulsed Field Ablation Versus Conventional Radiofrequency Catheter Ablation for Repeat PVI in Patients With Paroxysmal AF

Pulsed Field Ablation Versus Conventional Radiofrequency Catheter Ablation for Repeat

Sponsor

University Medical Center Groningen

Enrollment

154 participants

Start Date

Sep 20, 2024

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation Recurrent

Summary

Various methods exist for performing pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF), including thermal ablation and pulse-field ablation (PFA). However, in cases requiring a second PVI for recurrent AF, radiofrequency ablation (RFA) is utilized in nearly 95% of instances post-acquiring a 3D high-density map from the left atrium (LA). Up to 85% of patients experiencing recurrent AF after the initial PVI exhibit pulmonary vein (PV) reconnections, often identified as the cause of AF. PFA has demonstrated its safety and efficiency compared to RFA as a swift technique for performing ablation. Yet, whether PFA or RFA stands out as superior or safer when applied for a second PVI remains unclear, as no randomized controlled trial has investigated this comparison. The proposed REPEAT-AF trial aims to randomize 154 AF patients experiencing recurrent AF after the initial PVI, assigning them in a 1:1 ratio to either RFA or PFA. Each patient will receive an implantable cardiac monitor to precisely detect any AF recurrences.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study compares two methods for treating atrial fibrillation (AFib) that has returned after a previous ablation procedure: pulsed field ablation (a newer, gentler form of energy that targets only heart tissue) versus conventional radiofrequency catheter ablation (heat-based). The goal is to see which is safer and more effective for repeat procedures. **You may be eligible if...** - You are 18–80 years old - You have paroxysmal (comes and goes) AFib with documented recurrence (lasting more than 30 seconds) - You have had one previous pulmonary vein isolation procedure within the last 5 years (by cryoballoon, radiofrequency, or pulsed field) - Your AFib causes symptoms - You are willing to attend all follow-up visits **You may NOT be eligible if...** - You have persistent or permanent AFib (lasting more than 1 year) - You have had more than one previous ablation procedure - Your AFib is caused by a reversible condition (e.g., thyroid disease) - You had a recent heart attack within the past 90 days 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

DEVICEpulmonary vein isolation with RFA

Patients randomised to RFA will undergo PVI with point-by-point RFA.

DEVICEpulmonary vein isolation with PFA

Patients randomised to PFA will undergo PVI with PFA.

Locations(1)

UMCG

Groningen, Netherlands

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NCT06199180

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