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

NCT07320768 | Not Yet Recruiting

• 1 other identifier: IS25217
• Study Type: interventional
• Target: 86
• Locations: 0 countries
• Sites: N/A

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. 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. 2.Is PFA+RDN safe, as measured by procedure-related serious adverse events through 30 days?

Conditions

Persistent Atrial Fibrillation

Keywords

Persistent Atrial Fibrillation; renal denervation (RDN); pulsed-field ablation (PFA)

Outcome Measures

Primary Outcomes (1)

• Freedom from Atrial Arrhythmia Recurrence

  Absence of any documented atrial tachyarrhythmia - including atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) lasting ≥30 seconds - occurring

  within 12 Months After the Index Procedure

Secondary Outcomes (4)

• Freedom from AF recurrence

  within 3 months after the index procedure

• Atrial fibrillation burden

  at 3 months

• Change in blood pressure

  immediately, at 1 month, and at 3 months after procedure

• Major adverse cardiovascular events (MACE)

  up to 12 months after ablation

Study Arms (2)

pulsed-field ablation alone

SHAM COMPARATOR

Procedure: Pulsed-Field Ablation (PFA)

renal denervation combined with pulsed-field ablation

EXPERIMENTAL

Procedure: renal denervation; Procedure: Pulsed-Field Ablation (PFA)

Interventions

renal denervation PROCEDURE

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.

renal denervation combined with pulsed-field ablation

Pulsed-Field Ablation (PFA) PROCEDURE

Catheter-based PFA of the left atrium for wide-antral pulmonary vein isolation using a multielectrode PFA system. Entrance/exit block must be confirmed.

pulsed-field ablation alone; renal denervation combined with pulsed-field ablation

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Shineyo Medical Co., Ltd.: collaborator
• BRATTEA Medtech Co. Ltd: collaborator
• Shanghai Chest Hospital: lead

Related Publications (15)

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MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Wenzheng Han, M.D, PhD

CONTACT

+86 13585995881; wzhan_cardiology@foxmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician; Administrative Deputy Director, Department of Cardiology

Study Record Dates

• First Submitted: December 21, 2025
• First Posted: January 6, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share