RecruitingNCT06055751

Long Term Evaluation of Cardiac Arrhythmias After Transcatheter Aortic Valve Implantation -The LOCATE Registry

Kansas City Heart Rhythm Research FoundationOne US siteView on ClinicalTrials.gov

AI Description

The purpose of the Long term Evaluation of Cardiac Arrhythmias after Transcatheter Aortic Valve Implantation (LOCATE) Registry is to perform long-term ambulatory monitoring of patients with severe aortic stenosis who undergo trans-catheter aortic valve implantation (TAVI) and develop new onset conduction system abnormalities post-procedure that do not require urgent permanent pacemaker (PPM) implantation. The primary objectives of this study are to assess the incidence of late onset heart block necessitating PPM implantation and to evaluate the incidence of new onset atrial fibrillation (AF) following TAVI. This study aims to provide valuable insights into the long-term cardiac health of TAVI patients and inform the development of improved treatment strategies for aortic stenosis patients with conduction system abnormalities.

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Who can join
adult, older adult
Participants
50
Expected completion
2025-12
Funded by
other

Conditions studied

Aortic Stenosis, Atrial Fibrillation New Onset, Heart Block

What is being tested

  • DEVICE: TAVR Procedure and implantation of Boston Scientific Loop Recorder (LUX-Dx PMA# K193473)

What it measures

  • Incidence of brady arrhythmias, Incidence of significant brady arrhythmias (2:1 or higher-grade Atrioventricular block (AV) block) requiring pacemaker implantation post TAVI in patients with evidence of conduction system injury following TAVI, 12 Months
  • New onset Atrial Fibrillation, Assess the incidence of new onset atrial fibrillation post TAVI, 12 Months
  • Predictors of development of late onset heart block needing pacing, Evaluate predictors of development of late onset (\>30 days) heart block needing pacing, 12 Months

Centers Participating

These centers are participating in this study. Reach out to them directly to learn more.

Data Sources and Methodology

Registry entry updated 2024-10-16

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