Pacing of the Left Bundle Branch Area NEcessitated After TAVR
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Aortic Valve Stenosis
- Sponsor
- Ludwig-Maximilians - University of Munich
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- QRS duration
- Status
- Active, Not Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Moritz F. Sinner
Assistant Professor
Ludwig-Maximilians - University of Munich
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
Outcomes
Primary Outcomes
QRS duration
Time Frame: 3 months
QRS duration on 12-lead ECG, defined as earliest Q to latest S across all leads
Secondary Outcomes
- Death of any cause(24 months)
- Echocardiographic assessment of degreee of atrio-ventricular valve insufficiency(24 months)
- QRS duration(24 months)
- 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 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)