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

Shanghai Jiao Tong University

Status

Not yet enrolling

Conditions

Persistent Atrial Fibrillation

Treatments

Procedure: Pulsed-Field Ablation (PFA)

Procedure: renal denervation

Study type

Interventional

Funder types

Other

Identifiers

NCT07320768

IS25217

Details and patient eligibility

About

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:

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

Enrollment

86 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.