Clinical trial NCT06148571: Left Bundle Branch Area Pacing in Heart Failure Patients With Ejection Fraction Below Normal
Official title: Left Bundle Branch Area Pacing in Heart Failure Patients With Ejection Fraction Below Normal
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Left Ventricular Ejection Fraction Less Then or Equal to 50percent
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-11-28
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have EF below normal and require permanent cardiac pacing or CRT.

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.


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.

Primary outcomes:
measure: The acute success rate of left bundle branch area pacing
timeFrame: The day of the procedure
measure: Acute complications related to the procedures
timeFrame: 7 days from the procedure
Secondary outcomes:
measure: The incidence of acute procedure-related complication
timeFrame: 1 year
measure: The incidence of repeat procedures
timeFrame: 1 year
measure: The incidence of pacemaker upgrade to cardiac resynchronization therapy including biventricular cardiac pacing
timeFrame: 1 year
measure: The incidence of heart failure hospitalization
timeFrame: 1 year
measure: The incidence of cardiovascular death
timeFrame: 1 year
measure: The incidence of All-cause death
timeFrame: 1 year
measure: Left ventricular ejection fraction
timeFrame: 1 year
measure: Left ventricular end diastolic diameter
timeFrame: 1 year
measure: Left ventricular end systolic diameter
timeFrame: 1 year
measure: left ventricular global strain
timeFrame: 1 year
measure: Capture threshold
timeFrame: 1 year
measure: Sensing
timeFrame: 1 year
measure: Impedance
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-gu
Study officials:
affiliation: Seoul National University Hospital
name: Eue-Keun Choi, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: