Left Ventricular Ejection Fraction Less Then or Equal to 50percentNCT06148571
Left Bundle Branch Area Pacing in Heart Failure Patients With Ejection Fraction Below Normal
An observational study of Left Ventricular Ejection Fraction Less Then or Equal to 50percent, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Left Ventricular Ejection Fraction Less Then or Equal to 50percent
- What is being tested?
- left bundle branch area pacing
- Type of treatment
- Medical device
- How many people
- 142 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Oct 2023to 3 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have EF below normal and require permanent cardiac pacing or CRT.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Jongno-gu, 03080
About this study
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.
- Being tested
- left bundle branch area pacing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
left bundle branch area pacingDevice
left bundle branch area pacing locates ventricular lead into the interventricular septum to capture left bundle branch areas.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Device: left bundle branch area pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 7 days from the procedure
Secondary outcomes (13)
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)
Measured: 1 year
The incidence of repeat procedures
The incidence of repeat left bundle branch area pacing procedures
Measured: 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
Measured: 1 year
The incidence of heart failure hospitalization
The incidence of heart failure hospitalization
Measured: 1 year
The incidence of cardiovascular death
The incidence of cardiovascular death
Measured: 1 year
The incidence of All-cause death
The incidence of All-cause death
Measured: 1 year
Left ventricular ejection fraction
Left ventricular ejection fraction (%)
Measured: 1 year
Left ventricular end diastolic diameter
Left ventricular end diastolic diameter (mm)
Measured: 1 year
Left ventricular end systolic diameter
Left ventricular end systolic diameter (mm)
Measured: 1 year
left ventricular global strain
left ventricular global strain (%) if possible.
Measured: 1 year
Capture threshold
Left bundle branch area pacing lead parameter: capture threshold (V)
Measured: 1 year
Sensing
Left bundle branch area pacing lead parameter: sensing (mV)
Measured: 1 year
Impedance
Left bundle branch area pacing lead parameter: impedance (Ohms)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start10 Oct 2023
- Primary completion3 Jul 2026
- Study completion3 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular Ejection Fraction Less Then or Equal to 50percentStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eue-Keun Choi, Seoul National University Hospital
- Investigators
- Eue-Keun Choi, M.D. Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148571
- Sponsor's protocol ID
- LBBAP-HF
- Status last verified
- Aug 2026
- First submitted
- 4 Oct 2023
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Bundle Branch Area Pacing in Heart Failure Patients With Ejection Fraction Below Normal
- ClinicalTrials.gov ID
- NCT06148571
- Acronym / sponsor ID
- LBBAP-HF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 3 Jul 2026 (actual)
- Study completion
- 3 Jul 2026 (actual)
- First posted
- 28 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective LBBAP-HF cohort | – | Device: left bundle branch area pacingPatient who underwent attempted left bundle branch area pacing using Biotronik Selectra 3D sheath and stylet driven lead (Solia S60, Biotronik). |
| Retrospective LBBAP-HF cohort | – | Device: left bundle branch area pacingPatients who underwent attempted left bundle branch area pacing using Biotronik Selectra 3D and Solia S60 lead prior to prospective enrollment. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have EF below normal and require permanent cardiac pacing or CRT.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| left bundle branch area pacingleft bundle branch area pacing locates ventricular lead into the interventricular septum to capture left bundle branch areas. | Device | Prospective LBBAP-HF cohort, Retrospective LBBAP-HF cohort |
Primary outcome
The acute success rate of left bundle branch area pacing
Time frame: The day of the procedure
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
Acute complications related to the procedures
Time frame: 7 days from the procedure
* 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
13 secondary outcomes
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
Impedance
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eue-Keun Choi, M.D. Ph.D. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Ventricular Ejection Fraction Less Then or Equal to 50percent, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The acute success rate of left bundle branch area pacing (time frame: The day of the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.