Aortic Valve Stenosis, AV Block, Pacing-Induced Cardiomyopathy
Conditions
Keywords
left bundle branch area pacing, av block, right ventricular pacing, aortic valve stenosis, TAVR, ECG
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.
Interventions
DEVICELeft 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.
DEVICERight 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.
Sponsors
Ludwig-Maximilians - University of Munich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
1:1 randomization
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| QRS duration | 3 months | QRS duration on 12-lead ECG, defined as earliest Q to latest S across all leads |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurence of arrhythmias | 3 months | — |
| Echocardiographic assessment of right ventricular ejection fraction | 3 months | — |
| Change in New York heart failure classification status | 3 months | — |
| Change in laboratory biomarkers NT-proBNP | 3 months | — |
| Change in functional status by 6 minute walk | 3 months | — |
| Change in EQ-5D quality of life | 3 months | — |
| QRS duration | 12 months | QRS duration on 12-lead ECG, defined as earliest Q to latest S across all leads |
| Death of any cause | 3 months | — |
| Death of cardio-vascular cause | 3 months | — |
| Re-hospitalization due to heart failure | 3 months | — |
| Change in left ventricular ejection fraction | 3 months | — |
| Change in echocardiographic left ventricular enddiastolic diameter | 3 months | — |
| Echocardiographic assessment of degreee of atrio-ventricular valve insufficiency | 3 months | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| procedural implantation success | basline | dichotomous yes / no |
| Implantation procedure duration | baseline | — |
| Fluoroscopy duration | baseline | — |
| Fluoroscopy dose | baseline | — |
| Pacemaker-associated complications | 3 months | — |
Countries
Germany
Outcome results
None listed