Left Bundle Branch Area Pacing in Patients After TAVR

Aortic Valve Stenosis Clinical Trial

— PLANET  

Official title:

Pacing of the Left Bundle Branch Area NEcessitated After TAVR

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05024279
• Other study ID #: 21-0575
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 6, 2021
• Est. completion date: April 2025

Study information

• Verified date: January 2023
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: April 2025
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	LMU Klinikum	Munich	BY

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pacemaker-associated complications		3 months
Other	Pacemaker-associated complications		12 months
Other	Pacemaker-associated complications		24 months
Other	procedural implantation success	dichotomous yes / no	basline
Other	Implantation procedure duration		baseline
Other	Fluoroscopy duration		baseline
Other	Fluoroscopy dose		baseline
Primary	QRS duration	QRS duration on 12-lead ECG, defined as earliest Q to latest S across all leads	3 months
Secondary	QRS duration	QRS duration on 12-lead ECG, defined as earliest Q to latest S across all leads	12 months
Secondary	QRS duration	QRS duration on 12-lead ECG, defined as earliest Q to latest S across all leads	24 months
Secondary	Death of any cause		3 months
Secondary	Death of any cause		12 months
Secondary	Death of any cause		24 months
Secondary	Death of cardio-vascular cause		3 months
Secondary	Death of cardio-vascular cause		12 months
Secondary	Death of cardio-vascular cause		24 months
Secondary	Re-hospitalization due to heart failure		3 months
Secondary	Re-hospitalization due to heart failure		12 months
Secondary	Re-hospitalization due to heart failure		24 months
Secondary	Change in left ventricular ejection fraction		3 months
Secondary	Change in left ventricular ejection fraction		12 months
Secondary	Change in left ventricular ejection fraction		24 months
Secondary	Change in echocardiographic left ventricular enddiastolic diameter		3 months
Secondary	Change in echocardiographic left ventricular enddiastolic diameter		12 months
Secondary	Change in echocardiographic left ventricular enddiastolic diameter		24 months
Secondary	Echocardiographic assessment of degreee of atrio-ventricular valve insufficiency		3 months
Secondary	Echocardiographic assessment of degreee of atrio-ventricular valve insufficiency		12 months
Secondary	Echocardiographic assessment of degreee of atrio-ventricular valve insufficiency		24 months
Secondary	Echocardiographic assessment of right ventricular ejection fraction		3 months
Secondary	Echocardiographic assessment of right ventricular ejection fraction		12 months
Secondary	Echocardiographic assessment of right ventricular ejection fraction		24 months
Secondary	Change in New York heart failure classification status		3 months
Secondary	Change in New York heart failure classification status		12 months
Secondary	Change in New York heart failure classification status		24 months
Secondary	Change in laboratory biomarkers NT-proBNP		3 months
Secondary	Change in laboratory biomarkers NT-proBNP		12 months
Secondary	Change in laboratory biomarkers NT-proBNP		24 months
Secondary	Change in functional status by 6 minute walk		3 months
Secondary	Change in functional status by 6 minute walk		12 months
Secondary	Change in functional status by 6 minute walk		24 months
Secondary	Change in EQ-5D quality of life		3 months
Secondary	Change in EQ-5D quality of life		12 months
Secondary	Change in EQ-5D quality of life		24 months
Secondary	Occurence of arrhythmias		3 months
Secondary	Occurence of arrhythmias		12 months
Secondary	Occurence of arrhythmias		24 months