NCT05024279

Left Bundle Branch Area Pacing in Patients After TAVR

Pacing of the Left Bundle Branch Area NEcessitated After TAVR

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Ludwig-Maximilians - University of Munich · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Aortic Valve Stenosis
• AV Block
• Pacing-Induced Cardiomyopathy

Interventions

Type	Name	Description
DEVICE	Left bundle branch area pacing	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.
DEVICE	Right ventricular pacing	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.

Timeline

• Start date: 2021-08-06
• Primary completion: 2023-04-01
• Completion: 2025-04-01
• First posted: 2021-08-27
• Last updated: 2023-01-31

Locations

1 site across 1 country: Germany