The goal of this clinical trial is to learn whether adding renal denervation (RDN) to pulsed-field ablation (PFA) reduces blanking-period recurrence of atrial tachyarrhythmias in adults (≥18 years) with persistent atrial fibrillation undergoing first-time ablation while off antiarrhythmic drugs. The main questions it aims to answer are: 1. Does PFA+RDN, compared with PFA alone, reduce the proportion of participants with any AF/atrial flutter/atrial tachycardia ≥30 seconds during the 90-day blanking period? 2. Is PFA+RDN safe, as measured by procedure-related serious adverse events through 30 days?
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
86
Renal denervation is a catheter-based procedure performed after renal angiography confirms no significant stenosis. A specialized catheter delivers low-energy pulses inside both renal arteries to disrupt overactive sympathetic nerves surrounding the vessels. Energy is applied in a spiral pattern from distal to proximal segments. The procedure is performed during the same session as PFA under anticoagulation.
Catheter-based PFA of the left atrium for wide-antral pulmonary vein isolation using a multielectrode PFA system. Entrance/exit block must be confirmed.
Freedom from Atrial Arrhythmia Recurrence
Absence of any documented atrial tachyarrhythmia - including atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) lasting ≥30 seconds - occurring
Time frame: within 12 Months After the Index Procedure
Freedom from AF recurrence
Absence of any documented atrial fibrillation (AF) episode lasting ≥ 30 seconds after a single ablation procedure, without use of antiarrhythmic drugs during follow-up.
Time frame: within 3 months after the index procedure
Atrial fibrillation burden
AF burden measured by 24-hour (or longer) Holter monitoring at 3 months, calculated as the proportion of AF duration to total recording time, in participants not receiving antiarrhythmic drugs.
Time frame: at 3 months
Change in blood pressure
Change in systolic and diastolic blood pressure from baseline to post-procedure, 1-month, and 3-month follow-up visits.
Time frame: immediately, at 1 month, and at 3 months after procedure
Major adverse cardiovascular events (MACE)
Incidence of death, stroke, heart failure, major bleeding, non-stroke thromboembolic events, and cardiovascular hospitalization, reported both as individual and composite outcomes.
Time frame: up to 12 months after ablation
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