Left Bundle Branch Area Pacing in Patients After TAVR
- Conditions
- Aortic Valve StenosisAV BlockPacing-Induced Cardiomyopathy
- Interventions
- Device: Right ventricular pacingDevice: Left bundle branch area pacing
- Registration Number
- NCT05024279
- Lead Sponsor
- Ludwig-Maximilians - University of Munich
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Arm Right ventricular pacing Patients are randomized to receive standard right ventricular pacing due to higher degree AV block. Intervention Arm Left bundle branch area pacing Patients are randomized to receive left bundle branch are pacing due to higher degree AV block
- Primary Outcome Measures
Name Time Method QRS duration 3 months QRS duration on 12-lead ECG, defined as earliest Q to latest S across all leads
- Secondary Outcome Measures
Name Time Method Death of any cause 24 months QRS duration 24 months QRS duration on 12-lead ECG, defined as earliest Q to latest S across all leads
Death of cardio-vascular cause 24 months Re-hospitalization due to heart failure 24 months Change in left ventricular ejection fraction 24 months Change in echocardiographic left ventricular enddiastolic diameter 24 months Echocardiographic assessment of degreee of atrio-ventricular valve insufficiency 24 months Echocardiographic assessment of right ventricular ejection fraction 24 months Change in New York heart failure classification status 24 months Change in laboratory biomarkers NT-proBNP 24 months Change in functional status by 6 minute walk 24 months Change in EQ-5D quality of life 24 months Occurence of arrhythmias 24 months
Trial Locations
- Locations (1)
LMU Klinikum
🇩🇪Munich, BY, Germany