Left Bundle Branch Area Pacing in Patients After TAVR (PLANET)

Ludwig Maximilian University of Munich

Status: Active, not recruiting

Conditions: Aortic Valve Stenosis; AV Block; Pacing-Induced Cardiomyopathy

Treatments: Device: Right ventricular pacing; Device: Left bundle branch area pacing

Study type: Interventional

Funder types: Other

Identifiers

NCT05024279

21-0575

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Intervention Arm

Experimental group

Description:

Patients are randomized to receive left bundle branch are pacing due to higher degree AV block

Treatment:

Device: Left bundle branch area pacing

Control Arm

Active Comparator group

Description:

Patients are randomized to receive standard right ventricular pacing due to higher degree AV block.

Treatment:

Device: Right ventricular pacing