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

Seoul National University

Status: Enrolling

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

Treatments: Device: left bundle branch area pacing

Study type: Observational

Funder types: Other

Identifiers

NCT06148571

LBBAP-HF

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 2 patient groups

Prospective LBBAP-HF cohort

Description:

Patient who underwent attempted left bundle branch area pacing using Biotronik Selectra 3D sheath and stylet driven lead (Solia S60, Biotronik).

Treatment:

Device: left bundle branch area pacing

Retrospective LBBAP-HF cohort

Description:

Patients who underwent attempted left bundle branch area pacing using Biotronik Selectra 3D and Solia S60 lead prior to prospective enrollment.

Treatment:

Device: left bundle branch area pacing