Left Bundle Branch Area Pacing in Patients After TAVR

Ludwig-Maximilians - University of Munich30 enrolled

Overview

Prospective, randomized, single center clinical trial to compare the outcome of left bundle branch area pacing versus right ventricular apical pacing in patients with higher degree atrio-ventricular block and a normal left ventricular function after transcatheter aortic valve replacement.

Transcatheter aortic valve replacement (TAVR) is a well-established treatment of aortic valve stenosis. Yet, requiry of permanent pacing due to new onset atrio-ventricular conduction block remains a frequent complication. Standard right ventricular pacing (RVP) at high pacing burden may lead to deterioration of left ventricular function. Left-Bundle-Area Pacing (LBBP) is a new, innovative method of physiological ventricular stimulation resulting in narrow, physiological QRS complexes. In this prospective, randomized, single center clinica trial, patients are included after TAVR and with normal left ventricular function who require pacing due to a higher degree atriao-ventricular block with an anticipated high pacing burden. Patients will be randomized to receive either left bundle branch area pacing (intervention) or right ventricular apical pacing (control). The results will confirm the feasibility of LBBP in patients following TAVR. Results will further investigate the primary outcome of a clinically relevant QRS narrowing and a combination of exploratory secondary endpoints including clinical outcomes, functional status, laboratory biomarkers, and quality of life.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Aortic Valve Stenosis AV Block Pacing-Induced Cardiomyopathy

Interventions

Left bundle branch area pacingDEVICE

Left bundle branch area pacing will be applied as established in the literature using commercially available equipment. In case of unsuccessful application of left bundle branch area pacing, cross-over to right ventricular pacing is allowed.

Right ventricular pacingDEVICE

Right ventricular pacing as the standard, established form of pacing will be applied in the control group. No cross-over to the intervention arm is anticipated.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Successful TAVR implantation for classical (high flow high gradient), symptomatic aortic valve stenosis * LVEF ≥50% * Guideline-based indication for pacing due to AV block III°, AV block II°, or symptomatic bradycardic atrial fibrillation with an expecteed ventricular pacing burden \>20% * Signed informeed conseent to study participation Exclusion Criteria: * LVEF \<50% * Expected pacing burden \<20% * Pre-existing implanted cardiac device * Participation in a concurring interventional trial * age \<18 years * Current preegnancy * life expectancy \<6 months

Locations (1)

LMU Klinikum

Munich, Bavaria, Germany

Outcomes

Primary Outcomes

QRS duration

QRS duration on 12-lead ECG, defined as earliest Q to latest S across all leads

Time frame: 3 months

Secondary Outcomes

QRS duration

QRS duration on 12-lead ECG, defined as earliest Q to latest S across all leads

Time frame: 12 months

QRS duration

QRS duration on 12-lead ECG, defined as earliest Q to latest S across all leads

Time frame: 24 months

Death of any cause

Time frame: 3 months

Death of any cause

Time frame: 12 months

Death of any cause

Time frame: 24 months

Death of cardio-vascular cause

Time frame: 3 months

Death of cardio-vascular cause

Time frame: 12 months

Death of cardio-vascular cause

Time frame: 24 months

Re-hospitalization due to heart failure

Time frame: 3 months

Re-hospitalization due to heart failure

Time frame: 12 months

Re-hospitalization due to heart failure

Data from ClinicalTrials.gov

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