Clinical Trial

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

Study acronym: OFF-MED
Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
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?
Protocol Amendment History 1 change
critical Trial status changed: Not Yet Recruiting → Active, Not Recruiting 2026-05-30
Trial Details
NCT Number NCT07320768
Lead Sponsor Shanghai Chest Hospital
Collaborators: Shanghai Shineyo Medical Co., Ltd., BRATTEA Medtech Co. Ltd
Conditions Persistent Atrial Fibrillation
Enrollment 86 participants
Start Date 2026-01-01
Primary Completion 2027-01-01 (estimated)
Study Completion 2027-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-29