Persistent Atrial Fibrillation
Conditions
Keywords
Persistent Atrial Fibrillation, renal denervation (RDN), pulsed-field ablation (PFA)
Brief 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?
Interventions
PROCEDURErenal 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.
PROCEDUREPulsed-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.
Sponsors
Shanghai Chest Hospital
Shanghai Shineyo Medical Co., Ltd.
BRATTEA Medtech Co. Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from Atrial Arrhythmia Recurrence | 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
| Measure | Time frame | Description |
|---|---|---|
| Freedom from atrial tachyarrhythmia recurrence | 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 |
| Atrial fibrillation burden | 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. |
| Change in blood pressure | 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. |
| Major adverse cardiovascular events (MACE) | 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. |
| Changes in serum creatinine levels during follow-up. | During 12 months | Changes in renal function during follow-up. Using serum creatinine levels for assessment. |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]), reported both as individual and composite outcomes. | 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. |
Countries
China
Outcome results
None listed