Brief Title
Left Bundle Branch Area Pacing in Patients After TAVR
Official Title
Pacing of the Left Bundle Branch Area NEcessitated After TAVR
Brief 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.
Study Type
Interventional
Primary Outcome
QRS duration
Secondary Outcome
QRS duration
Condition
Aortic Valve Stenosis
Intervention
Left bundle branch area pacing
Study Arms / Comparison Groups
Intervention Arm
Description: Patients are randomized to receive left bundle branch are pacing due to higher degree AV block
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
30
Start Date
August 6, 2021
Completion Date
December 2022
Primary Completion Date
October 2022
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Moritz F Sinner, MD, MPH, +49-89-4400, [email protected]
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT05024279
Organization ID
21-0575
Responsible Party
Principal Investigator
Study Sponsor
Ludwig-Maximilians - University of Munich
Study Sponsor
Moritz F Sinner, MD, MPH, Principal Investigator, LMU Klinikum, Dept. of Cardiology
Verification Date
April 2022