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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| left bundle branch area pacing | Device | left bundle branch area pacing locates ventricular lead into the interventricular septum to capture left bundle branch areas. |
|
| 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.
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 |
| 7 days from the procedure |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who have EF below normal and require permanent cardiac pacing or CRT.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eue-Keun Choi, M.D. Ph.D. | Contact | 82-2-2072-0688 | choiek417@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Eue-Keun Choi, M.D. Ph.D. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | Jongno-gu | 03080 | South Korea |
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| 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 |