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

May 28, 2026 updated by: Wenzheng Han, Shanghai Chest Hospital

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

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?

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200030
        • Shanghai Chest Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: pulsed-field ablation alone
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.
Experimental: renal denervation combined with pulsed-field ablation
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within 12 Months After the Index Procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 12 months after ablation
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
within 3 months after the index procedure
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.
at 3、6、9、12 months
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.
immediately, at 1 month, and at 3 months after procedure
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.
During 12 months
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]), reported both as individual and composite outcomes.
Time Frame: 1 month after procedure
  1. Cardiac complications: pericardial effusion, cardiac tamponade, pericarditis, myocardial injury, coronary artery spasm or injury, and clinically significant bradyarrhythmia.
  2. Vascular complications: access-site bleeding, hematoma, pseudoaneurysm, arteriovenous fistula, arterial dissection, and vascular occlusion.
  3. Renal complications: renal artery stenosis, renal artery dissection, renal artery perforation or rupture, renal infarction, and clinically significant decline in renal function.
  4. Neurological events: stroke and transient ischemic attack.
  5. Thromboembolic events.
  6. Major bleeding.
  7. Symptomatic hypotension.
  8. Death.
  9. Other serious adverse events judged related or possibly related to the study procedure.
1 month after procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Chest Hospital

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

December 21, 2025

First Submitted That Met QC Criteria

December 21, 2025

First Posted (Actual)

January 6, 2026

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IS25217

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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