Left Bundle Branch Area Pacing in Heart Failure Patients With Ejection Fraction Below Normal

Study Overview
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Brief Summary
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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.

Official Title
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Left Bundle Branch Area Pacing in Heart Failure Patients With Ejection Fraction Below Normal

Conditions
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Left Ventricular Ejection Fraction Less Then or Equal to 50percent

Intervention / Treatment
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* Device: left bundle branch area pacing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prospective LBBAP-HF cohort<br>Patient who underwent attempted left bundle branch area pacing using Biotronik Selectra 3D sheath and stylet driven lead (Solia S60, Biotronik). | Device: left bundle branch area pacing<br>* left bundle branch area pacing locates ventricular lead into the interventricular septum to capture left bundle branch areas.<br>|
| Retrospective LBBAP-HF cohort<br>Patients who underwent attempted left bundle branch area pacing using Biotronik Selectra 3D and Solia S60 lead prior to prospective enrollment. | Device: left bundle branch area pacing<br>* left bundle branch area pacing locates ventricular lead into the interventricular septum to capture left bundle branch areas.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The acute success rate of left bundle branch area pacing | 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 | The day of the procedure | 
| Acute complications related to the procedures | 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 | 7 days from the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of acute procedure-related complication | The acute procedure-related complication was defined as the occurrence of the below-listed events within 7 days of the procedure. (Death related to the procedure, Pocket hematoma, Pseudoaneurysm, Fistular, Vascular rupture, Device-related infection, Cardiac perforation, Cardiac tamponade, Septal perforation, Acute coronary syndrome, Pneumothorax, Hemothorax, Stroke, Pulmonary thromboembolism, Lead dislodgement) | 1 year | 
| The incidence of repeat procedures | The incidence of repeat left bundle branch area pacing procedures | 1 year | 
| The incidence of pacemaker upgrade to cardiac resynchronization therapy including biventricular cardiac pacing | The incidence of pacemaker upgrade to cardiac resynchronization therapy including biventricular cardiac pacing | 1 year | 
| The incidence of heart failure hospitalization | The incidence of heart failure hospitalization | 1 year | 
| The incidence of cardiovascular death | The incidence of cardiovascular death | 1 year | 
| The incidence of All-cause death | The incidence of All-cause death | 1 year | 
| Left ventricular ejection fraction | Left ventricular ejection fraction (%) | 1 year | 
| Left ventricular end diastolic diameter | Left ventricular end diastolic diameter (mm) | 1 year | 
| Left ventricular end systolic diameter | Left ventricular end systolic diameter (mm) | 1 year | 
| left ventricular global strain | left ventricular global strain (%) if possible. | 1 year | 
| Capture threshold | Left bundle branch area pacing lead parameter: capture threshold (V) | 1 year | 
| Sensing | Left bundle branch area pacing lead parameter: sensing (mV) | 1 year | 
| Impedance | Left bundle branch area pacing lead parameter: impedance (Ohms) | 1 year |