Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2021-08-06
2025-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention Arm
Patients are randomized to receive left bundle branch are pacing due to higher degree AV block
Left 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.
Control Arm
Patients are randomized to receive standard right ventricular pacing due to higher degree AV block.
Right 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.
Interventions
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Left 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.
Right 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Expected pacing burden \<20%
* Pre-existing implanted cardiac device
* Participation in a concurring interventional trial
* age \<18 years
* Current preegnancy
* life expectancy \<6 months
18 Years
ALL
No
Sponsors
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Ludwig-Maximilians - University of Munich
OTHER
Responsible Party
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Moritz F. Sinner
Assistant Professor
Principal Investigators
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Moritz F Sinner, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
LMU Klinikum, Dept. of Cardiology
Stephanie Fichtner, MD
Role: PRINCIPAL_INVESTIGATOR
LMU Klinikum, Dept. of Cardiology
Locations
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LMU Klinikum
Munich, Bavaria, Germany
Countries
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Other Identifiers
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21-0575
Identifier Type: -
Identifier Source: org_study_id
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