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Left Bundle Branch Area Pacing in Patients After TAVR

NCT05024279 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-01-31

No results posted yet for this study

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.

Conditions

  • Aortic Valve Stenosis
  • AV Block
  • Pacing-Induced Cardiomyopathy

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

  • Ludwig-Maximilians - University of Munich

    lead OTHER

Principal Investigators

  • Moritz F Sinner, MD, MPH · LMU Klinikum, Dept. of Cardiology

  • Stephanie Fichtner, MD · LMU Klinikum, Dept. of Cardiology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-06
Primary Completion
2023-04-30
Completion
2025-04-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05024279 on ClinicalTrials.gov