Adjunctive Renal Denervation to Modify Hypertension and Sympathetic Tone as Upstream Therapy in the Treatment of Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 15
- 主要终点
- Anti-arrhythmic Drug (AAD)-Free Single-procedure Freedom From Atrial Fibrillation Recurrence
研究概览
简要总结
The objective of the H-FIB trial is to determine the role of renal sympathetic denervation in the prevention of Atrial Fibrillation (AF) recurrence in patients with hypertension for whom a catheter-based AF ablation procedure is planned. Patients will be randomized to either AF catheter ablation (usual therapy) or AF catheter ablation plus renal sympathetic denervation.
详细描述
The purpose of this study is to examine the potential additional benefit of performing renal sympathetic denervation at the same time as an AF ablation procedure, in order to improve the long-term success of the AF procedure.
To take part in this study, you must meet all study requirements. Screening visit tests and procedures such as a physical exam, blood pressure, review of medical history, blood sample, and a Transthoracic Echocardiogram (TTE) are done to see if you are eligible to be in the study.
Patients who qualify for the study and provide consent will undergo catheter ablation for AF. Very thin electrode catheters, similar to long wires, will be inserted into blood vessels in the groin. Using the ablation catheter, we will "ablate" or damage the tissue adjacent to your pulmonary veins that is not behaving normally.
Immediately following the catheter ablation, patients will undergo a renal angiogram in order to assess suitability for catheter-based renal sympathetic denervation. A renal angiogram is an x-ray study of the blood vessels in the kidney to evaluate for blockage, and abnormalities that could be affecting the blood supply to the kidney. It is performed by injecting contrast dye through a catheter (a tiny tube) into the blood vessels of the kidney.
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)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria
- •Age ≥ 18 years of age
- •History of AF (paroxysmal or persistent) and planned for a guideline-supported catheter ablation procedure
- •History of significant hypertension (defined as SBP ≥160 mm Hg and/or DBP ≥100 mmHg) and receiving treatment with at least one anti-hypertensive medication OR Clinical History of hypertension and receiving treatment with at least two anti-hypertensive medications (specifically for blood pressure reduction).
- •Renal vasculature is accessible as determined by intra-procedural renal angiography.
- •Ability to understand the requirements of the study
- •Willingness to adhere to study restrictions, comply with all post-procedural follow-up requirements and to sign informed consent
- •Exclusion Criteria
- •Inability to undergo AF catheter ablation (e.g., presence of a left atrial thrombus, contraindication to all anticoagulation)
- •Prior left atrial ablation for an atrial arrhythmia (before this index procedure)
- •Patients with NYHA class IV congestive heart failure
- •Individual has known secondary hypertension
- •Individual has renal artery anatomy that is ineligible for treatment including:
- •Inability to access renal vasculature
- •Main renal arteries < 3 mm in diameter or < 20 mm in length.
- •Hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery which, in the eyes of the operator, would interfere with safe cannulation of the renal artery or meets standards for surgical repair or interventional dilation.
- •A history of prior renal artery intervention including balloon angioplasty or stenting that precludes a possibility of ablation treatment.
- •Individual has an estimated glomerular filtration rate (eGFR) of less than 45mL/min/1.73m2, using the MDRD calculation.
- •Individual has a single functioning kidney (either congenitally or iatrogenically).
- •Individual is pregnant or nursing.
- •Life expectancy <1 year for any medical condition
排除标准
- 未提供
结局指标
主要结局
Anti-arrhythmic Drug (AAD)-Free Single-procedure Freedom From Atrial Fibrillation Recurrence
时间窗: up to 12 months
The primary endpoint of this study is anti-arrhythmic drug (AAD)-free single-procedure freedom from AF recurrence through 12 months (not including a 90 day blanking period).
次要结局
- AAD-free Single-procedure Freedom From AF Recurrence(up to 24 months)
- Freedom From AF Recurrence Despite Taking AADs(up to 24 months)
- Blood Pressure Control as Compared to Baseline(baseline, 6 months, 12 months, and 24 months)
- Number of Participants With Major Adverse Cardiac Events (MACE)(within 12 months of randomization)
- Number of Participants With Serious Adverse Events (SAE)(up to 24 months)
- Left Atrial (LA) Size(at baseline and at 12 months)
- Ejection Fraction (EF)(at baseline and at 12 months)
- Number of Participants With Procedure Adverse Events(up to 24 months)
- Number of Anti-hypertensive Medications(baseline and 24 months)
- Atrial Fibrillation Effect on QualiTy-of-life Questionnaire (AFEQT)(baseline, 12 months and 24 months)
研究者
Vivek Reddy
Director Cardiac Arrhythmia Service, Professor of Medicine
Icahn School of Medicine at Mount Sinai