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

Pacing of the Left Bundle Branch Area NEcessitated After TAVR

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Valve Stenosis; AV Block; Pacing-Induced Cardiomyopathy
• Intervention / Treatment: Device: Left bundle branch area pacing; Device: Right ventricular pacing

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Moritz F Sinner, MD, MPH; Phone Number: 76159 +49-89-4400; Email: msinner@med.lmu.de
• Study Contact Backup: Name: Stephanie Fichtner, MD; Phone Number: 73034 +49-89-4400; Email: stephanie.fichtner@med.uni-muenchen.de

Study Locations

• Germany
  • BY
    • Munich, BY, Germany, 81377
      • Recruiting
      • LMU Klinikum
      • Contact: Moritz F Sinner, MD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; Patients are randomized to receive left bundle branch are pacing due to higher degree AV block	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.
Active Comparator: Control Arm; Patients are randomized to receive standard right ventricular pacing due to higher degree AV block.	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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pacemaker-associated complications		3 months
Pacemaker-associated complications		12 months
Pacemaker-associated complications		24 months
procedural implantation success	dichotomous yes / no	basline
Implantation procedure duration		baseline
Fluoroscopy duration		baseline
Fluoroscopy dose		baseline

Collaborators and Investigators

• Sponsor: Ludwig-Maximilians - University of Munich
• Investigators: Principal Investigator: Moritz F Sinner, MD, MPH, LMU Klinikum, Dept. of Cardiology; Principal Investigator: Stephanie Fichtner, MD, LMU Klinikum, Dept. of Cardiology

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2021
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: August 9, 2021
• First Submitted That Met QC Criteria: August 22, 2021
• First Posted (Actual): August 27, 2021

Study Record Updates

• Last Update Posted (Actual): April 8, 2022
• Last Update Submitted That Met QC Criteria: April 7, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: aortic valve stenosis; left bundle branch area pacing; av block; right ventricular pacing; TAVR; ECG
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Cardiac Conduction System Disease; Heart Block; Aortic Valve Stenosis; Cardiomyopathies; Atrioventricular Block
• Other Study ID Numbers: 21-0575

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No