A Feasibility Study to Evaluate the Effect of Concomitant Renal Denervation and Cardiac Ablation on AF Recurrence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 4
- 主要终点
- Number of Participants With Freedom From Atrial Fibrillation at 12 Month
研究概览
简要总结
The purpose of this post market clinical investigation is to complete preliminary evaluation on whether or not concomitant renal denervation with the EnligHTN™ Renal Denervation System and cardiac ablation will result in improved outcomes as compared to ablation alone in patients with uncontrolled hypertension being treated for Atrial Fibrillation
详细描述
This is a post market, prospective, multicenter, 2:1 randomized study of the EnligHTN™ Renal Denervation System in conjunction with atrial fibrillation ablation. Up to one hundred subjects with paroxysmal or persistent atrial fibrillation and uncontrolled hypertension will be enrolled in the study. All subjects will undergo cardiac ablation for the treatment of atrial fibrillation. Per the 2:1 randomization, a minimum of 50 or 2/3 of the total patient cohort will also undergo renal artery ablation. Subjects will be followed up to years (2) years post procedure.
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
- 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
- •Subject is ≥ 18 years of age at time of consent
- •Subject must be able and willing to provide written informed consent
- •Subject must be able and willing to comply with the required follow-up schedule
- •Subject is a candidate for catheter ablation for the treatment of paroxysmal or persistent atrial fibrillation as per the hospital standard of care
- •Subject has office Systolic Blood Pressure ≥ 140 mmHg at baseline visit
- •Subject has a daytime mean Systolic Ambulatory Blood Pressure > 135 mmHg within 90 days prior to procedure
- •Subject has established hypertension (diagnosed ≥12 month prior to baseline) and is taking >3 anti-hypertensive medications, including 1 diuretic
- •Subject has been on a stable unchanged anti-hypertensive medication regimen for a minimum of 4 weeks prior to the ablation procedure
排除标准
- •Subject has long standing atrial fibrillation
- •Subject has had a previous ablation for atrial fibrillation
- •Subject has had a previous renal denervation procedure
- •Subject has had a CABG procedure within the last 180 days (six months)
- •Subject has a left atrial thrombus
- •Subject has a contraindication to anticoagulation (i.e. heparin or warfarin)
- •Subject has unstable angina
- •Subject has had a myocardial infarction within the previous two months
- •Subject has a left ventricular ejection fraction (LVEF) <40% as determined by pre-procedure TTE
- •Subject has significant renovascular abnormalities such as renal artery stenosis > 30%
- •Subject has undergone prior renal angioplasty, renal denervation, indwelling renal stents, and/or abdominal aortic stent grafts
- •Subject has hemodynamically significant valvular heart disease as determined by study investigator
- •Subject has a life expectancy less than 12 months, as determined by the study investigator
- •Subject is participating in another clinical study which has the potential to impact his/her hypertension or atrial fibrillation management (pharmaceutical/device/homeopathic)
- •Subject is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods
- •Subject has active systemic infection
- •Subject has renal arteries < 4 mm in diameter
- •Subject has an estimated GFR <45 mL/min per 1.73 m2 using the Modification of Diet in Renal Disease (MDRD) formula
- •Subject had a renal transplant or is awaiting a renal transplant
- •Subject has blood clotting or bleeding abnormalities
- •Subject has secondary arterial hypertension
结局指标
主要结局
Number of Participants With Freedom From Atrial Fibrillation at 12 Month
时间窗: 12 months
The freedom from atrial fibrillation was assessed based on electrocardiographic data during nine months following the blanking period including the one week recording coinciding with the 12 month follow-up visit (9 months following the 3 month blanking period).
次要结局
- Recurrence of Atrial Fibrillation (AF) Based on Electrocardiographic Data up to 2 Years Following the Initial Cardiac Ablation Procedure.(3 months, 6 months, 12 months, 24 months)
- Change in Ambulatory Blood Pressure at 12 Months(Baseline and 12 months post procedure)
- Renal Function Change Based on Estimated Glomerular Filtration Rate (eGFR) (Renal Denervation Group Only) at 6 Months(Baseline and 6 months)
- Percentage of Participants Who Experience Peri-procedural Events(30 days post procedure)
- Change in Office Blood Pressure at 12 Months(Baseline and 12 months post procedure)
- Change in Office Blood Pressure at 24 Months(Baseline and 24 months post procedure)
- Assessment of Renovascular Safety as Measured by New Renal Artery Stenosis or Aneurysm at the Site of Ablation(6 months and 12 months post procedure)
- Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg(6 months post procedure)
- Major Adverse Cardiac Events (MACE)(7 days, 6 months, 12 months, and 24 months post procedure)
- Renal Function Change Based on eGFR (Renal Denervation Group Only) at 12 Months(Baseline and 12 months)
- Change in Ambulatory Blood Pressure at 24 Months(Baseline and 24 months post procedure)