Left Bundle Branch Pacing Versus Conventional Pacing in Atrioventricular Block

University Hospital of Patras

Status: Completed

Conditions: Atrioventricular Nodal Disease

Treatments: Device: Right ventricular active fixation lead; Device: Left bundle branch pacing lead (Select Secure 3830 lead)

Study type: Interventional

Funder types: Other

Identifiers

NCT05129098

251/10-05-21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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38 participants in 2 patient groups

Left Bundle Branch Pacing

Experimental group

Description:

Implantation of a left bundle branch lead via sheath, to perform left bundle branch pacing

Treatment:

Device: Left bundle branch pacing lead (Select Secure 3830 lead)

Conventional Right Venticular Pacing

Active Comparator group

Description:

The ventricular lead will be implanted in the right ventricle in the conventional way

Treatment:

Device: Right ventricular active fixation lead