NCT07320768Active, not recruiting
Renal Denervation Combined With Pulsed Field Ablation to Prevent Recurrence in Persistent Atrial Fibrillation
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
Source: ClinicalTrials.gov · Last updated 29 May 2026
Brief summary (registry, in English)
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?
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 86 (estimated)
- First submitted
- 21 Dec 2025
- Start date
- 1 Jan 2026
- Primary completion date
- 1 Jan 2027
- Lead sponsor
- Shanghai Chest Hospital
- Diseases
- Atrial fibrillation
- NCT number
- NCT07320768
What you commit to
- Study type: Interventional
- Planned participants: 86
- From 1 Jan 2026 to the primary completion date, 1 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
Other illness
- Presence of advanced structural heart disease.
- Secondary atrial fibrillation due to electrolyte imbalance, thyroid disorders, or other reversible or non-cardiac causes.
Lab values
- 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).
- Heart failure with left ventricular ejection fraction \< 30% documented by transthoracic echocardiography within 3 months before ablation.
Other
- 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.
- Known inability to obtain vascular access or contraindication to femoral venous puncture.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Chest Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.