Renal Denervation Combined With Pulsed Field Ablation to Prevent Recurrence in Persistent Atrial Fibrillation

The Efficacy and Safety of Renal Denervation Combined With Pulsed Field Ablation in Preventing Recurrence of Atrial Arrhythmia in Patients With Persistent Atrial Fibrillation: An OFF-MED Trial

The goal of this clinical trial is to learn whether adding renal denervation (RDN) to pulsed-field ablation (PFA) reduces 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 at 12 month?
2. Is PFA+RDN safe, as measured by procedure-related serious adverse events through 30 days?

Inclusion Criteria:

• Age > 18 years.
• Patients with persistent atrial fibrillation undergoing first-time catheter ablation (defined as any episode lasting ≥7 days).
• Symptomatic atrial fibrillation refractory to or intolerant of at least one class I or III antiarrhythmic drug and scheduled for guideline-directed catheter ablation.
• Able to understand the study purpose, voluntarily participate, and sign the written informed consent form.

Exclusion Criteria:

• Presence of advanced structural heart disease.
• Life expectancy < 12 months.
• Blood pressure < 90/60 mmHg.
• Pregnant or lactating women.
• Anatomical abnormalities of the renal arteries unsuitable for treatment as determined by pre-procedural renal CTA.
• History of renal artery intervention, impaired renal function with estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m² (calculated by the MDRD equation).
• Secondary atrial fibrillation due to electrolyte imbalance, thyroid disorders, or other reversible or non-cardiac causes.
• Contraindication to pulsed-field ablation (e.g., left atrial thrombus, prior atrial septal defect occluder implantation, or permanent metallic implant in the left atrium) or to anticoagulation therapy.
• Known inability to obtain vascular access or contraindication to femoral venous puncture.
• Heart failure with left ventricular ejection fraction < 30% documented by transthoracic echocardiography within 3 months before ablation.
• Patients with current or anticipated need for pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT), or prior transseptal closure with occluder device for atrial septal defect or patent foramen ovale.