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
研究组 & 干预措施
HBP Group
CRT Device and His-bundle Pacing. Patients will get His-bundle pacing through a CRT device first for 9 months then switch to Bi-ventricular pacing by the same CRT device for another 9 months.
干预措施: CRT Device and Bi-ventricular pacing (Device)
HBP Group
CRT Device and His-bundle Pacing. Patients will get His-bundle pacing through a CRT device first for 9 months then switch to Bi-ventricular pacing by the same CRT device for another 9 months.
干预措施: CRT Device and His-bundle Pacing (Device)
BiVP Group
CRT Device and Bi-ventricular Pacing. Patients will get BiV pacing for 9 months through a CRT device then switch to His-bundle pacing by the same CRT device for another 9 months.
干预措施: CRT Device and Bi-ventricular pacing (Device)
BiVP Group
CRT Device and Bi-ventricular Pacing. Patients will get BiV pacing for 9 months through a CRT device then switch to His-bundle pacing by the same CRT device for another 9 months.
干预措施: CRT Device and His-bundle Pacing (Device)
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 average pacing impedance (ohm)(18 months)
- 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)
研究者
Weijiang Huang
Dean of Cardiology, First Affiliated Hospital of Wenzhou Medical University
First Affiliated Hospital of Wenzhou Medical University