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

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.

Study Overview

• Status: Recruiting
• Conditions: Left Ventricular Ejection Fraction Less Then or Equal to 50percent
• Intervention / Treatment: Device: left bundle branch area pacing

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Eue-Keun Choi, M.D. Ph.D.; Phone Number: 82-2-2072-0688; Email: choiek417@gmail.com

Study Locations

• South Korea
  • Jongno-gu
    • Seoul, Jongno-gu, South Korea, 03080
      • Recruiting
      • Seoul National University Hospital
      • Contact: Eue-Keun Choi; Phone Number: 82-2-2072-0688; Email: choiek417@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who have EF below normal and require permanent cardiac pacing or CRT.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	Device: left bundle branch area pacing; left bundle branch area pacing locates ventricular lead into the interventricular septum to capture left bundle branch areas.
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.	Device: left bundle branch area pacing; left bundle branch area pacing locates ventricular lead into the interventricular septum to capture left bundle branch areas.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Eue-Keun Choi, M.D. Ph.D., Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2023
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 4, 2023
• First Submitted That Met QC Criteria: November 27, 2023
• First Posted (Actual): November 28, 2023

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: LBBAP-HF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No