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NCT Number: NCT07320768

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

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?

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Key information

Conditions

Persistent Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Chest Hospital

Shanghai, 200030, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Freedom from Atrial Arrhythmia Recurrence

    Time frame: within 12 Months After the Index Procedure

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

Secondary outcomes

  1. Freedom from atrial tachyarrhythmia recurrence

    Time frame: within 3 months after the index procedure

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

  2. Atrial fibrillation burden

    Time frame: at 3、6、9、12 months

    AF burden measured by 24-hour (or longer) Holter monitoring at 3、6、9、12 months, calculated as the proportion of AF duration to total recording time, in participants not receiving antiarrhythmic drugs.

  3. Change in blood pressure

    Time frame: immediately, at 1 month, and at 3 months after procedure

    Change in systolic and diastolic blood pressure from baseline to post-procedure, 1, 3, 6, 12-month follow-up visits.

  4. Major adverse cardiovascular events (MACE)

    Time frame: up to 12 months after ablation

    Incidence of death, stroke, heart failure, major bleeding, non-stroke thromboembolic events, and cardiovascular hospitalization, reported both as individual and composite outcomes.

  5. Changes in serum creatinine levels during follow-up.

    Time frame: During 12 months

    Changes in renal function during follow-up. Using serum creatinine levels for assessment.

  6. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]), reported both as individual and composite outcomes.

    Time frame: 1 month after procedure

    • Cardiac complications: pericardial effusion, cardiac tamponade, pericarditis, myocardial injury, coronary artery spasm or injury, and clinically significant bradyarrhythmia.
    • Vascular complications: access-site bleeding, hematoma, pseudoaneurysm, arteriovenous fistula, arterial dissection, and vascular occlusion.
    • Renal complications: renal artery stenosis, renal artery dissection, renal artery perforation or rupture, renal infarction, and clinically significant decline in renal function.
    • Neurological events: stroke and transient ischemic attack.
    • Thromboembolic events.
    • Major bleeding.
    • Symptomatic hypotension.
    • Death.
    • Other serious adverse events judged related or possibly related to the study procedure.

Sponsors and collaborators

Lead sponsor

Shanghai Chest Hospital

Other

Collaborators

  • BRATTEA Medtech Co. Ltd
  • Shanghai Shineyo Medical Co., Ltd.

Registry information

Official study title

The Efficacy and Safety of Renal Denervation Combined With Pulsed Field Ablation in Preventing Recurrence of Atrial Arrhythmia in Patients With Persistent Atrial Fibrillation: An OFF-MED Trial

Acronym: OFF-MED

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 6, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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