Left Bundle Branch Area Pacing in Heart Failure Patients With Ejection Fraction Below Normal
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorSeoul National University Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial population
Patients who have EF below normal and require permanent cardiac pacing or CRT.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
left bundle branch area pacing
Deviceleft bundle branch area pacing locates ventricular lead into the interventricular septum to capture left bundle branch areas.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Prospective LBBAP-HF cohort1 intervention
Group B: Retrospective LBBAP-HF cohort1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
The day of the procedure2
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
Time frame
7 days from the procedureSecondary outcomes
1
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)
Time frame
1 year2
The incidence of repeat procedures
The incidence of repeat left bundle branch area pacing procedures
Time frame
1 year3
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
Time frame
1 year4
The incidence of heart failure hospitalization
The incidence of heart failure hospitalization
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov