Ultrasound-Based Renal Sympathetic Denervation as Adjunctive Upstream Therapy During Atrial Fibrillation Ablation: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 25
- 主要终点
- Single-procedure freedom from AT/AF/AFL recurrence ≥ 30 seconds
研究概览
简要总结
The purpose of the ULTRA-HFIB Pilot is to determine the role of adjunctive renal denervation (RDN) in the prevention of Atrial Fibrillation (AF) recurrence in patients scheduled for an AF ablation procedure. Patients will be randomized to either i) AF ablation (Control) or ii) AF ablation + renal sympathetic denervation (Intervention).
详细描述
The purpose of the ULTRA-HFIB Pilot is to determine the role of adjunctive renal denervation (RDN) in the prevention of AF recurrence in patients scheduled for an AF ablation procedure. Patients will be randomized to either i) AF ablation (Control) or ii) AF ablation + renal sympathetic denervation (Intervention). This is a prospective, controlled, single-blind, randomized trial. The pilot study will be conducted in up to 11 clinical sites in the United States and Europe.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Patients will be blinded until the 6 month visit, at which time they will be un-blinded prior to the follow up CT/MRI. The Clinical Events Committee and Echo Core Lab will remain blinded throughout the trial. In general, the CEC will be blinded to the treatment arms. However, once the nature of the event has been adjudicated, the blind will be broken for that individual patient as necessary to enable the CEC to determine relatedness to the study device.
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
- •Planned for a first-ever AF ablation procedure (paroxysmal or persistent); (prior to randomization, a technically successful AF ablation procedure, defined as involving pulmonary vein isolation, as well as bidirectional block of any attempted anatomic lesion sets such as cavotricuspid isthmus line, roofline, mitral line and superior vena cava isolation must have been completed)
- •History of hypertension and either:
- •Documented history of SBP ≥ 160 or DBP ≥ 100 (Stage III), or
- •Receiving ≥ 1 antihypertensive medication
- •Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements
排除标准
- •(if any of the following are YES, subject is not eligible)
- •Long-standing persistent AF (> 12 months)
- •Individual with valvular AF or AF due to a reversible cause
- •Prior left atrial catheter or surgical ablation for an atrial arrhythmia (before this index procedure)
- •Prior left atrial surgery (such as mitral valve surgery or surgical ASD repair)
- •Prior treatment with other devices for hypertension including but not limited to ROX Coupler, Mobius stent and/or the CVRx barostimulator device
- •NYHA Class IV Congestive Heart Failure
- •Individual has renal artery anatomy that is ineligible for treatment (as determined by intra-procedural renal angiography). This includes:
- •Main renal artery diameter < 3.0 mm or > 8.0 mm
- •Main renal artery length < 20 mm
- •Presence of renal artery stenosis of any origin ≥ 30%
- •Accessory arteries with diameter ≥ 2 mm and < 3.0 mm
- •Calcification in renal arteries at locations where energy is to be delivered
- •Prior renal denervation procedure
- •Presence of abnormal kidney tumors
- •Renal artery aneurysm
- •Pre-existing renal stent or history of renal artery angioplasty
- •Pre-existing aortic stent or history of aortic aneurysm
- •Fibromuscular disease of the renal arteries
- •Iliac/femoral artery stenosis precluding insertion of the Paradise Catheter
- •Individual has an estimated glomerular filtration rate (eGFR) of less than 40mL/min/1.73m2
- •Inability to undergo AF catheter ablation (e.g., presence of left atrial thrombus, contraindication to all anticoagulation)
- •Individual with known allergy to contrast medium not amenable to treatment
- •Life expectancy of < 1 year for any medical condition
- •Individual has experienced a myocardial infarction, unstable angina, cerebrovascular accident, or heart failure admission within 3 months of screening visit
- •Documented history of chronic active inflammatory bowel disorders such as Crohn's disease or ulcerative colitis
- •Female participants who are pregnant or nursing
- •Individual has known secondary hypertension
- •Individual has a single functioning kidney (either congenitally or iatrogenically)
- •Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements
- •Patients concurrently enrolled in any other investigational drug or device trial that would interfere with the conduction of this trial
结局指标
主要结局
Single-procedure freedom from AT/AF/AFL recurrence ≥ 30 seconds
时间窗: 12 months
Single-procedure freedom from AT/AF/AFL recurrence ≥ 30 seconds off Class I and III AADs (after the 90-day blanking period), defined by absence of any electrocardiographically documented AT/AF.
次要结局
- Rate of procedural adverse events(30 days)
- Change in office systolic blood pressure change from baseline to 12 months(12 months)
- AF burden at 6 months(6 months)
- AF burden at 12 months(12 months)
- Freedom from AT/AF/AFL recurrence(12 months)
- The Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) questionnaire(12 months)
研究者
Vivek Reddy
Professor
Icahn School of Medicine at Mount Sinai