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

NCT06148571 | Recruiting DMC

• 1 other identifier: LBBAP-HF
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Left Ventricular Ejection Fraction Less Then or Equal to 50percent

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• The incidence of acute procedure-related complication

  1 year

• The incidence of repeat procedures

  1 year

• The incidence of pacemaker upgrade to cardiac resynchronization therapy including biventricular cardiac pacing

  1 year

• The incidence of heart failure hospitalization

  1 year

• The incidence of cardiovascular death

  1 year

Study Arms (2)

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

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

Interventions

left bundle branch area pacing DEVICE

left bundle branch area pacing locates ventricular lead into the interventricular septum to capture left bundle branch areas.

Prospective LBBAP-HF cohort; Retrospective LBBAP-HF cohort

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

RECRUITING

Study Officials

• Eue-Keun Choi, M.D. Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eue-Keun Choi, M.D. Ph.D.

CONTACT

82-2-2072-0688; choiek417@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: November 28, 2023
• Study Start: October 10, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 18, 2025

Record last verified: 2025-05

Locations

KR (1)