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Search / Trial NCT05895097

Conventional Versus Left Bundle Branch Pacing in TAVI

Launched by UNIVERSITY MEDICAL CENTRE LJUBLJANA · Jun 5, 2023

Trial Information

Current as of June 27, 2025

Not yet recruiting

Keywords

Transcatheter Aortic Valve Implantation Left Bundle Branch Pacing

ClinConnect Summary

This clinical trial, called "Conventional Versus Left Bundle Branch Pacing in TAVI," is looking at how two different types of heart pacing affect patients who have undergone a procedure called transcatheter aortic valve implantation (TAVI). Specifically, it compares traditional pacing methods with a newer technique called left bundle branch pacing. The aim is to see which method better helps the heart recover and function well in patients with weakened heart function, known as reduced left ventricular ejection fraction (LVEF), who need a permanent pacemaker after TAVI.

To participate in this study, patients must need a permanent pacemaker after their TAVI procedure and have a left ventricular ejection fraction below 50%, which means their heart isn't pumping as well as it should. The trial is not yet recruiting participants, but if you meet these criteria and are between the ages of 65 and 74, you may be eligible. Participants can expect to receive either type of pacing during their hospital stay, and the study aims to gather important information about how these methods impact heart recovery over time.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Indication for permanent pacemaker implantation after transcatheter aortic valve implantation (during the same hospitalization)
  • Left ventricular ejection fraction \< 50 %.
  • Exclusion Criteria:
  • Unsuccessful TAVI procedure with life expectancy \< 1 year
  • Ischemic cardiomyopathy with interventricular septal fibrosis (at least echocardiographic signs of fibrosis)
  • Severe kidney failure (glomerular filtration rate \< 30 ml/min)
  • Previous permanent pacemaker

About University Medical Centre Ljubljana

University Medical Centre Ljubljana (UMCL) is a leading academic medical institution in Slovenia, dedicated to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, UMCL integrates cutting-edge medical practices with comprehensive patient care, fostering an environment of collaboration among healthcare professionals, researchers, and patients. With a strong emphasis on ethical standards and scientific integrity, UMCL aims to contribute to the global body of medical knowledge while improving treatment outcomes in various therapeutic areas.

Locations

Ljubljana, , Slovenia

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported