Clinical trial NCT05129098: Left Bundle Branch Pacing Versus Conventional Pacing in Atrioventricular Block
Official title: Left Bundle Branch Pacing Versus Conventional Pacing in Patients With Atrioventricular Node Disorders: a Randomized, Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrioventricular Nodal Disease
Lead sponsor: University Hospital of Patras
Sponsor class: OTHER
First posted: 2021-11-22
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recently, the concept of physiological pacing has emerged in the clinical practice, in an attempt to prevent the deteriorating effects of right ventricular pacing in the long-term. Left bundle branch pacing seems to be a safe procedure with promising results that may prevent intraventricular dyssynchony compared with the conventional right ventricular pacing.

Detailed description: In this prospective, randomized study the outcomes regarding echocardiographic indices of dyssynchrony in left bundle branch versus conventional right ventricular pacing in patients with atrioventricular node disease will be compared In recent years, His pacing has demonstrated better results regarding resynchronization compared to conventional biventricular pacing in trials of 3D mapping. However, technical difficulties that relate to unstable lead positioning or inability in succeeding low pacing threshold have led to low success rates. An alternative site of physiological pacing that could possibly overcome these issues, while maintaining ventricular synchrony is left bundle branch pacing. The lead implantation of LBB pacing is performed using the Select Secure (3830) pacing lead. The lead is screwed into the interventricular septum, until left bundle branch pacing is achieved. The randomized patients 24 hours after the procedure are echocardiographically evaluated and indices of mechanical dyssynchrony are recorded. Follow-up is conducted at 3 months, 6 months and one year post-procedure.

Eligibility criteria: Inclusion Criteria:

* Age\>18 years old
* Patients with atrioventricular block and EF\>50% with a predicted ventricular pacing rate\>20%
* Patients with intraventricular septal diameter\>8mm
* Written informed consent

Exclusion Criteria:

* Indication for CRT or ICD device
* Patients with no subclavian approach, who are candidates for leadless devices
* Presence of severe tricuspid regurgitation
* Patients who are candidates for implantation from the right side, as currently the provided tools for left bundle branch pacing fascilitate only left sided pacemaker implantations

Primary outcomes:
measure: Echocardiographic dyssynchrony index, as expressed with Global Left Ventricular Myocardial Work Efficiency (GWE) (%)
timeFrame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Secondary outcomes:
measure: Procedure Time (min)
timeFrame: 1 Day of procedure
measure: Fluoroscopy Time (min)
timeFrame: 1 Day of procedure
measure: Dose Area Product (DAP) (cGy/cm2)
timeFrame: 1 Day of procedure
measure: Implant success
timeFrame: 1 Day of procedure
measure: Complications associated with pacemaker implantation
timeFrame: through study completion at 1 year post randomisation
measure: B natriuretic peptide measurement (pg/ml)
timeFrame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
measure: Stroke volume index (SVi) (ml/m2)
timeFrame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
measure: Ejection Fraction (EF) (%)
timeFrame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
measure: Global Longitudinal Strain (GLS) (%)
timeFrame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
measure: Left Atrium Strain (%)
timeFrame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
measure: Left Atrium Strain Rate (1/s)
timeFrame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
measure: Aortic Time- Velocity Integral (TVI) (cm)
timeFrame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
measure: Global Work Index (GWI) (mmHg%)
timeFrame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
measure: Global Constructive Work (GCW) (mmHg%)
timeFrame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
measure: Global Wasted Work (GWW) (mmHg%)
timeFrame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
measure: Segmental CW, WW at the mid septal wall
timeFrame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
measure: Segmental CW, WW at the basal lateral wall
timeFrame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
measure: Peak Strain Dispersion (PSD) (msec)
timeFrame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
measure: Changes in capture threshold (V) in the ventricular lead
timeFrame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
measure: Changes in sense (mV) in the ventricular lead
timeFrame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Other outcomes:
Locations:
city: Patra
country: Greece
facility: University Hospital of Patras
state: Rion
Study officials:
affiliation: University Hospital of Patras
name: Georgios Leventopoulos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: