Left Bundle Branch Area Pacing in Heart Failure Patients With Ejection Fraction Below Normal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 3
- 主要终点
- The acute success rate of left bundle branch area pacing
研究概览
简要总结
While cardiac resynchronization therapy remains the mainstay for advanced HF, it is not always feasible due to unfavorable anatomy of coronary sinus or pacing characteristics. In such cases, left bundle branch area pacing itself or left bundle optimized cardiac resynchronization therapy could be a rescue therapy for failed or unsuccessful biventricular cardiac resynchronization therapy. However, the efficacy and safety of left bundle branch area pacing (or left bundle optimized cardiac resynchronization therapy) as rescue therapy for biventricular cardiac resynchronization therapy is largely hypothetic and lack concrete evidence still.
Therefore, there is an unmet need for the registry purposed for left bundle branch area pacing among heart failure with mid-range (or mildly reduced) ejection fraction and heart failure with reduced ejection fraction patients to investigate its efficacy and safety.
This study aims to investigate the efficacy and safety of left bundle branch area pacing in heart failure patients with ejection fraction below normal using Selectra catheters.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients previously diagnosed with heart failure with mid-range(or mildly reduced) ejection fraction and heart failure with reduced ejection fraction, which was documented by an appropriate echocardiographic study (Left ventricle ejection fraction <50%), and
- •Patients with indications of cardiac pacing or cardiac resynchronization therapy
排除标准
- •Patients aged less than 19 years.
- •Pregnant.
- •Patients with an expected life expectancy of less than 1 year.
- •Patients with a mechanical valve for the tricuspid valve.
- •Patients who need atrial pacing only.
- •Patients who are not capable of receiving a transvenous pacemaker for any reason.
研究组 & 干预措施
Retrospective LBBAP-HF cohort
Patients who underwent attempted left bundle branch area pacing using Biotronik Selectra 3D and Solia S60 lead prior to prospective enrollment.
干预措施: left bundle branch area pacing (Device)
Prospective LBBAP-HF cohort
Patient who underwent attempted left bundle branch area pacing using Biotronik Selectra 3D sheath and stylet driven lead (Solia S60, Biotronik).
干预措施: left bundle branch area pacing (Device)
结局指标
主要结局
The acute success rate of left bundle branch area pacing
时间窗: The day of the procedure
The acute success of left bundle branch area pacing was defined as below: Meet ≥2 criteria as follows evaluated at the end of the procedure. * Right bundle branch block configuration observed during unipolar tip pacing * Left bundle branch potential (Left bundle branch-Ventricular interval of 15 to 35ms) * Transition from nonselective Left bundle branch capture to selective Left bundle branch capture * Transition from nonselective Left bundle branch capture to left septal capture at near threshold outputs * Short and constant peak left ventricular activation time (stimulus to peak of the R wave in V5 or V6 \[peak left ventricle activation time\]) \<75ms in non-Left bundle branch block and \<85ms in Left bundle branch block Programmed (extra-stimulus testing) deep septal stimulation to differentiate left ventricular septal vs nonselective Left bundle branch capture
Acute complications related to the procedures
时间窗: 7 days from the procedure
* Death related to the procedure * Vascular complications (pocket hematoma, pseudoaneurysm, fistular, rupture) * Device-related infection * Cardiac perforation or tamponade * Septal perforation * Acute coronary syndrome * Pneumothorax, hemothorax * Thromboembolic events (stroke, pulmonary thromboembolism) * Lead dislodgment
次要结局
- The incidence of cardiovascular death(1 year)
- The incidence of All-cause death(1 year)
- The incidence of heart failure hospitalization(1 year)
- left ventricular global strain(1 year)
- Capture threshold(1 year)
- The incidence of pacemaker upgrade to cardiac resynchronization therapy including biventricular cardiac pacing(1 year)
- The incidence of acute procedure-related complication(1 year)
- The incidence of repeat procedures(1 year)
- Left ventricular end diastolic diameter(1 year)
- Impedance(1 year)
- Left ventricular ejection fraction(1 year)
- Left ventricular end systolic diameter(1 year)
- Sensing(1 year)
研究者
Eue-Keun Choi
Professor
Seoul National University Hospital