NCT07320768

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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?

Conditions

• Persistent Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	renal denervation	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.
PROCEDURE	Pulsed-Field Ablation (PFA)	Catheter-based PFA of the left atrium for wide-antral pulmonary vein isolation using a multielectrode PFA system. Entrance/exit block must be confirmed.

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-01-01
• Completion: 2027-06-01
• First posted: 2026-01-06
• Last updated: 2026-01-06