Concomitant Renal Denervation Therapy in Hypertensive Patients Undergoing Atrial Fibrillation Ablation - A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Atrial fibrillation (AF) Time to recurrence and Burden
研究概览
简要总结
We propose a pilot study to assess safety and benefit of renal artery ablation at the time of planned atrial fibrillation ablation.
详细描述
Symptomatic atrial fibrillation (AF) refractory to anti-arrhythmic drugs is commonly treated with ablation therapy. Pulmonary vein isolation along with additional substrate medication is commonly performed during ablation procedures is associated with 60-80% success rate for maintenance of sinus rhythm. After AF ablation hypertension (HTN) is a strong predictor for recurrence of atrial fibrillation. Drug resistant hypertension can be effectively treated with catheter based renal denervation therapy. Our primary hypothesis is concomitant renal denervation therapy along with AF ablation is associated with improvement in success rates of AF ablation along with adequate control of blood pressure. The specific objectives of this study are to prospectively compare success rates, time to AF recurrence, AF burden and blood pressure controls in patients randomized to concomitant renal denervation arm when compared to patients with AF ablation alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
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
- •Paroxysmal and Persistent Atrial Fibrillation refractory eligible for AF ablation as per HRS/ECAS/EHRA consensus statement.[23] Paroxysmal AF is defined as two or more episodes of AF lasting less than 7 days in duration during the last 6 months before enrollment. Persistent AF is defined as AF lasting more than 7 days or requiring cardioversion for termination.
- •Hypertension (>140/80 mm Hg) on treatment with at least 1 hypertensive medication.
- •GFR >60ml/dl using Cockcroft- Gault equation
排除标准
- •Secondary causes of hypertension
- •Severe renal artery stenosis or dual renal arteries
- •Congestive heart failure with NYHA class III or IV status
- •LA Diameter >6 cm
- •Previous AF ablation
- •Previous renal artery stent or angioplasty
- •Severe contrast allergy
- •Inability to give informed consent
- •Solitary kidney
结局指标
主要结局
Atrial fibrillation (AF) Time to recurrence and Burden
时间窗: 1 year
After 3 months of blanking period, time to recurrence of atrial arrhythmia lasting more than 30 seconds is measured during follow up. (Atrial fibrillation)AF burden is assessed on a 7 day duration event monitor. Electrocardiogram (EKG) or Event monitor strips will be evaluated by independent board certified physicians.
Hypertension control
时间窗: 1 year
BP is obtained as per Joint National Committee (JNC 7) standards at 3, 6 and 12 month visits of follow up. Information regarding titration of antihypertensives or reduction in the number of medications to adequately control blood pressure is collected.
次要结局
- Glomerular Filtration Rate (GFR) at 3, 6 and 12 months(1 year)
- Renal artery complications by Crosssectional Imaging (Magnetic Resonance Imaging or computed tomography(3months)
- Quality of life scores (MAFSI- Mayo Atrial Fibrillation Symptom Index)(1 year)
- Change in left atrial volume parameters(1 year)
研究者
Siva Mulpuru
M.D., Assistant Professor of Medicine
Mayo Clinic