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Recruiting NCT06148571

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

— Observational Left Ventricular Ejection Fraction Less Then or Equal to 50percent

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: left bundle branch area pacing.
Who it may be relevant to
Registry conditions: Left Ventricular Ejection Fraction Less Then or Equal to 50percent. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

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

Primary outcome measures

  • The acute success rate of left bundle branch area pacing [Time frame: The day of the procedure]
  • Acute complications related to the procedures [Time frame: 7 days from the procedure]
Secondary outcome measures (12)
  • The incidence of acute procedure-related complication [Time frame: 1 year]
  • The incidence of repeat procedures [Time frame: 1 year]
  • The incidence of pacemaker upgrade to cardiac resynchronization therapy including biventricular cardiac pacing [Time frame: 1 year]
  • The incidence of heart failure hospitalization [Time frame: 1 year]
  • The incidence of cardiovascular death [Time frame: 1 year]
  • The incidence of All-cause death [Time frame: 1 year]
  • Left ventricular ejection fraction [Time frame: 1 year]
  • Left ventricular end diastolic diameter [Time frame: 1 year]
  • Left ventricular end systolic diameter [Time frame: 1 year]
  • left ventricular global strain [Time frame: 1 year]
  • Capture threshold [Time frame: 1 year]
  • Sensing [Time frame: 1 year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

South Korea · 1 center
  • Seoul National University Hospital — Seoul

Identifiers

NCT: NCT06148571 · LBBAP-HF

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗