Renal Denervation Combined With Pulsed Field Ablation to Prevent Recurrence in Persistent Atrial … (NCT07320768) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Renal Denervation Combined With Pulsed Field Ablation to Prevent Recurrence in Persistent Atrial Fibrillation
China86 participantsStarted 2026-01-01
Plain-language summary
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?
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 n…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Freedom from Atrial Arrhythmia Recurrence
Timeframe: within 12 Months After the Index Procedure