Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:10 AM
Study NCT ID:
NCT07320768
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-06
First Post:
2025-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Renal Denervation Combined With Pulsed Field Ablation to Prevent Blanking-Period Recurrence in Persistent Atrial Fibrillation
Sponsor:
Shanghai Chest Hospital
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OFF-MED
Brief 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?
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?
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: