Left Bundle Branch Area Pacing in Patients After TAVR

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pacing of the Left Bundle Branch Area NEcessitated After TAVR

Conditions
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Aortic Valve Stenosis, AV Block, Pacing-Induced Cardiomyopathy

Intervention / Treatment
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* Device: Left bundle branch area pacing
* Device: Right ventricular pacing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1 randomization
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>Patients are randomized to receive left bundle branch are pacing due to higher degree AV block | Device: Left bundle branch area pacing<br>* 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.<br>|
| Active Comparator: Control Arm<br>Patients are randomized to receive standard right ventricular pacing due to higher degree AV block. | Device: Right ventricular pacing<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QRS duration | QRS duration on 12-lead ECG, defined as earliest Q to latest S across all leads | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QRS duration | QRS duration on 12-lead ECG, defined as earliest Q to latest S across all leads | 12 months | 
| QRS duration | QRS duration on 12-lead ECG, defined as earliest Q to latest S across all leads | 24 months | 
| Death of any cause |  | 3 months | 
| Death of any cause |  | 12 months | 
| Death of any cause |  | 24 months | 
| Death of cardio-vascular cause |  | 3 months | 
| Death of cardio-vascular cause |  | 12 months | 
| Death of cardio-vascular cause |  | 24 months | 
| Re-hospitalization due to heart failure |  | 3 months | 
| Re-hospitalization due to heart failure |  | 12 months | 
| Re-hospitalization due to heart failure |  | 24 months | 
| Change in left ventricular ejection fraction |  | 3 months | 
| Change in left ventricular ejection fraction |  | 12 months | 
| Change in left ventricular ejection fraction |  | 24 months | 
| Change in echocardiographic left ventricular enddiastolic diameter |  | 3 months | 
| Change in echocardiographic left ventricular enddiastolic diameter |  | 12 months | 
| Change in echocardiographic left ventricular enddiastolic diameter |  | 24 months | 
| Echocardiographic assessment of degreee of atrio-ventricular valve insufficiency |  | 3 months | 
| Echocardiographic assessment of degreee of atrio-ventricular valve insufficiency |  | 12 months | 
| Echocardiographic assessment of degreee of atrio-ventricular valve insufficiency |  | 24 months | 
| Echocardiographic assessment of right ventricular ejection fraction |  | 3 months | 
| Echocardiographic assessment of right ventricular ejection fraction |  | 12 months | 
| Echocardiographic assessment of right ventricular ejection fraction |  | 24 months | 
| Change in New York heart failure classification status |  | 3 months | 
| Change in New York heart failure classification status |  | 12 months | 
| Change in New York heart failure classification status |  | 24 months | 
| Change in laboratory biomarkers NT-proBNP |  | 3 months | 
| Change in laboratory biomarkers NT-proBNP |  | 12 months | 
| Change in laboratory biomarkers NT-proBNP |  | 24 months | 
| Change in functional status by 6 minute walk |  | 3 months | 
| Change in functional status by 6 minute walk |  | 12 months | 
| Change in functional status by 6 minute walk |  | 24 months | 
| Change in EQ-5D quality of life |  | 3 months | 
| Change in EQ-5D quality of life |  | 12 months | 
| Change in EQ-5D quality of life |  | 24 months | 
| Occurence of arrhythmias |  | 3 months | 
| Occurence of arrhythmias |  | 12 months | 
| Occurence of arrhythmias |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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left bundle branch area pacing, av block, right ventricular pacing, aortic valve stenosis, TAVR, ECG