Left Bundle Branch Pacing Versus Conventional Pacing in Atrioventricular Block

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-13

Study Completion Date

2022-12-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Atrioventricular Nodal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Left Bundle Branch Pacing

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

Group Type EXPERIMENTAL

Left bundle branch pacing lead (Select Secure 3830 lead)

Intervention Type DEVICE

Implantation of a left bundle branch pacing lead via sheath

Conventional Right Venticular Pacing

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

Group Type ACTIVE_COMPARATOR

Right ventricular active fixation lead

Intervention Type DEVICE

Active fixation lead (standard)

Interventions

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Left bundle branch pacing lead (Select Secure 3830 lead)

Implantation of a left bundle branch pacing lead via sheath

Intervention Type DEVICE

Right ventricular active fixation lead

Active fixation lead (standard)

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No