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

NCT07320768 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2026-01-06

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Shanghai Shineyo Medical Co., Ltd.

    collaborator UNKNOWN

  • BRATTEA Medtech Co. Ltd

    collaborator UNKNOWN

  • Shanghai Chest Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2027-01-01
Completion
2027-06-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07320768 on ClinicalTrials.gov