Comparison of His Bundle Pacing (HBP) and Bi-Ventricular Pacing(BiVP) in Heart Failure (HF) Patients With Atrial Fibrillation (AF) Who Need Atrial-Ventricular Node (AVN) Ablation
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change of LVEF(%) from baseline in HBP and BiV Group
研究概览
简要总结
This study is a multicenter, prospective, randomized cross-over study to compare His Bundle Pacing (HBP) with Bi-Ventricular Pacing (BiVP) in HF Patients with AF who need atrial-ventricular node ablation.
详细描述
Patients who meet the inclusion and exclusion criteria will be enrolled into the study. In the study, both atrial-ventricular node(AVN) ablation and Cardiac Resynchronization Therapy (CRT) implantation are performed with HBP lead implanted and connected with the A port of CRT device. Followed with successful AVN ablation, HBP lead and CRT implantation, patients are 1:1 randomized into BiVP and HBP group for 9 months and then crossover for another 9 months. The primary end points of the study is the change of left ventricular ejection fraction (LVEF) in both HBP and BiV pacing group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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 at least 18 years old
- •Subject or authorized legal guardian or representative has signed and dated the Informed
- •Subject is expected to remain available for follow-up visits at the study center
- •Subjects with heart failure NYHA Class II-IV
- •Subjects with LVEF no greater than 40%
- •Subjects with persistent atrial fibrillation or atrial flutter with uncontrolled ventricular rate
排除标准
- •Subjects with the width of ECG Q, R, S wave (QRS) complex >120ms
- •Subjects with life expectancy less than 3 years
- •Subjects with mechanical right heart valve
- •Subjects with primary valvular disease
- •Subjects with heart transplant, or is currently on a heart transplant list
- •Subjects who are pregnant, or of childbearing potential and not on a reliable form of birth control
- •Subjects with significant renal dysfunction, as manifested by serum creatinine level >2.5 mg/dl or ≥275 μmol/L or estimated glomerular filtration rate (GFR) ≤30 mL/min/1.72 m2, which is documented within the 30 days prior to enrollment or at baseline.
- •Subjects with significant hepatic dysfunction, as evidenced by a hepatic function panel (serum) > 3 times upper limit of normal, which is documented within the 30 days prior to enrollment or at baseline.
- •Subjects with chronic or treatment-resistant severe anemia (hemoglobin <10.0 g/dL), which is documented within the 30 days prior to enrollment or at baseline
结局指标
主要结局
Change of LVEF(%) from baseline in HBP and BiV Group
时间窗: 18 months
次要结局
- Change of LV end systolic diameter(mm) from baseline(18 months)
- Change of average pacing threshold (V)(18 months)
- Change of 6min walking distance (m) from the baseline(18 months)
- Change of LV end diastolic diameter(mm) from baseline(18 months)
- The number of heart failure hospitalization after the procedure group(18 months)
- Change of Average sensing amplitude (V)(18 months)
- Change of Quality of Life(18 months)
- The number of patients with heart failure hospitalization after the procedure(18 months)
- Change of New York Heart Association (NYHA) Classification from baseline(18 months)
- Change of average pacing impedance (ohm)(18 months)
研究者
Weijiang Huang
Dean of Cardiology, First Affiliated Hospital of Wenzhou Medical University
First Affiliated Hospital of Wenzhou Medical University