NCT07320768进行中（未招募）不适用
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
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Freedom from Atrial Arrhythmia Recurrence
研究概览
简要总结
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:
- Does PFA+RDN, compared with PFA alone, reduce the proportion of participants with any AF/atrial flutter/atrial tachycardia ≥30 seconds at 12 month?
- Is PFA+RDN safe, as measured by procedure-related serious adverse events through 30 days?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
pulsed-field ablation alone
Sham Comparator
干预措施: Pulsed-Field Ablation (PFA) (Procedure)
renal denervation combined with pulsed-field ablation
Experimental
干预措施: renal denervation (Procedure)
renal denervation combined with pulsed-field ablation
Experimental
干预措施: Pulsed-Field Ablation (PFA) (Procedure)
结局指标
主要结局
Freedom from Atrial Arrhythmia Recurrence
时间窗: 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
次要结局
- Freedom from AF recurrence(within 3 months after the index procedure)
- Atrial fibrillation burden(at 3 months)
- Change in blood pressure(immediately, at 1 month, and at 3 months after procedure)
- Major adverse cardiovascular events (MACE)(up to 12 months after ablation)
研究者
Wenzheng Han
Associate Chief Physician; Administrative Deputy Director, Department of Cardiology
Shanghai Chest Hospital
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
Effects of Pulsed Electromagnetic Field Therapy on Sport Performance and RecoveryNCT07288892Nanyang Technological University30
招募中
不适用
Combined Effects of INF and OEP in Patients With Diabetic Peripheral NeuropathyDiabetic Peripheral NeuropathyNCT07274735Riphah International University65
已完成
不适用
Pulsed Electromagnetic Field Therapy for Neuropathic Pain in Lumbar Disc HerniationNCT07263737Haydarpasa Numune Training and Research Hospital46
招募中
不适用
Ultrasound Neuroimmune Modulation in Adults With Rheumatoid ArthritisRheumatoid ArthritisNCT07293871Surf Therapeutics40
招募中
不适用
Radical Nephroureterectomy With vs Without Template Lymph Node Dissection in High-Risk Upper Tract Urothelial Carcinoma (T-LND UTUC)Upper Tract Urothelial CarcinomaNCT07321210Tianjin Medical University Second Hospital150