Pulsed field ablation with Renal denervation for persistent Atrial fibrIllation: Rationale and design of the PRAISE-AF randomized trial.

BACKGROUND

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia worldwide and is associated with increased risks of stroke, heart failure, hospitalization, disability, and mortality. Catheter ablation has become an established rhythm-control strategy for symptomatic AF; however, the recurrence rate after ablation remains substantial, especially in patients with persistent AF. Pulsed field ablation (PFA) is an emerging nonthermal ablation technology with myocardial tissue selectivity and a potentially improved safety profile compared with conventional thermal ablation. Renal denervation (RDN) reduces sympathetic nervous system activity and has shown promising effects in reducing AF recurrence when combined with catheter ablation, mainly in patients with paroxysmal AF and hypertension. Whether RDN combined with PFA improves rhythm outcomes in patients with persistent AF remains unknown.

TRIAL

DESIGN

This is a single center, prospective, randomized, patient-blinded, sham-controlled pilot exploratory trial. A total of 86 patients with symptomatic persistent AF undergoing first-time catheter ablation will be enrolled and randomly assigned in a 1:1 ratio to receive either PFA combined with RDN or PFA combined with a sham RDN procedure. Antiarrhythmic drugs (AADs) will be discontinued after the index procedure in both groups. The primary endpoint is freedom from documented atrial tachyarrhythmia recurrence, including AF, atrial flutter, or atrial tachycardia lasting more than 30 seconds, within 12 months after a single ablation procedure without AADs. Secondary endpoints include freedom from atrial tachycardia recurrence within 3 months, AF burden, blood pressure changes, and major adverse cardiovascular events. Safety endpoints include cardiac, vascular, renal, and other procedure-related adverse events.

CONCLUSIONS

This trial will assess the safety and efficacy of PFA with RDN in a postablation contemporary persistent AF patient population.

TRIAL REGISTRATION: ClinicalTrials.gov:NCT07320768.