Clinical trial NCT05024279: Left Bundle Branch Area Pacing in Patients After TAVR
Official title: Pacing of the Left Bundle Branch Area NEcessitated After TAVR
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aortic Valve Stenosis
AV Block
Pacing-Induced Cardiomyopathy
Keywords: left bundle branch area pacing
av block
right ventricular pacing
aortic valve stenosis
TAVR
ECG
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2021-08-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomization
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: QRS duration
timeFrame: 3 months
Secondary outcomes:
measure: QRS duration
timeFrame: 12 months
measure: QRS duration
timeFrame: 24 months
measure: Death of any cause
timeFrame: 3 months
measure: Death of any cause
timeFrame: 12 months
measure: Death of any cause
timeFrame: 24 months
measure: Death of cardio-vascular cause
timeFrame: 3 months
measure: Death of cardio-vascular cause
timeFrame: 12 months
measure: Death of cardio-vascular cause
timeFrame: 24 months
measure: Re-hospitalization due to heart failure
timeFrame: 3 months
measure: Re-hospitalization due to heart failure
timeFrame: 12 months
measure: Re-hospitalization due to heart failure
timeFrame: 24 months
measure: Change in left ventricular ejection fraction
timeFrame: 3 months
measure: Change in left ventricular ejection fraction
timeFrame: 12 months
measure: Change in left ventricular ejection fraction
timeFrame: 24 months
measure: Change in echocardiographic left ventricular enddiastolic diameter
timeFrame: 3 months
measure: Change in echocardiographic left ventricular enddiastolic diameter
timeFrame: 12 months
measure: Change in echocardiographic left ventricular enddiastolic diameter
timeFrame: 24 months
measure: Echocardiographic assessment of degreee of atrio-ventricular valve insufficiency
timeFrame: 3 months
measure: Echocardiographic assessment of degreee of atrio-ventricular valve insufficiency
timeFrame: 12 months
measure: Echocardiographic assessment of degreee of atrio-ventricular valve insufficiency
timeFrame: 24 months
measure: Echocardiographic assessment of right ventricular ejection fraction
timeFrame: 3 months
measure: Echocardiographic assessment of right ventricular ejection fraction
timeFrame: 12 months
measure: Echocardiographic assessment of right ventricular ejection fraction
timeFrame: 24 months
measure: Change in New York heart failure classification status
timeFrame: 3 months
measure: Change in New York heart failure classification status
timeFrame: 12 months
measure: Change in New York heart failure classification status
timeFrame: 24 months
measure: Change in laboratory biomarkers NT-proBNP
timeFrame: 3 months
measure: Change in laboratory biomarkers NT-proBNP
timeFrame: 12 months
measure: Change in laboratory biomarkers NT-proBNP
timeFrame: 24 months
measure: Change in functional status by 6 minute walk
timeFrame: 3 months
measure: Change in functional status by 6 minute walk
timeFrame: 12 months
measure: Change in functional status by 6 minute walk
timeFrame: 24 months
measure: Change in EQ-5D quality of life
timeFrame: 3 months
measure: Change in EQ-5D quality of life
timeFrame: 12 months
measure: Change in EQ-5D quality of life
timeFrame: 24 months
measure: Occurence of arrhythmias
timeFrame: 3 months
measure: Occurence of arrhythmias
timeFrame: 12 months
measure: Occurence of arrhythmias
timeFrame: 24 months
Other outcomes:
measure: Pacemaker-associated complications
timeFrame: 3 months
measure: Pacemaker-associated complications
timeFrame: 12 months
measure: Pacemaker-associated complications
timeFrame: 24 months
measure: procedural implantation success
timeFrame: basline
measure: Implantation procedure duration
timeFrame: baseline
measure: Fluoroscopy duration
timeFrame: baseline
measure: Fluoroscopy dose
timeFrame: baseline
Locations:
city: Munich
country: Germany
facility: LMU Klinikum
state: BY
Study officials:
affiliation: LMU Klinikum, Dept. of Cardiology
name: Moritz F Sinner, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: LMU Klinikum, Dept. of Cardiology
name: Stephanie Fichtner, MD
role: PRINCIPAL_INVESTIGATOR
References: