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

NCT06055751 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2024-10-16

No results posted yet for this study

Summary

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.

Conditions

  • Aortic Stenosis
  • Atrial Fibrillation New Onset
  • Heart Block

Interventions

DEVICE

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

No intervention will be done as part of this prospective registry. Implantation of Boston Scientific Loop Recorder (LUX-Dx) will be performed regardless of this research and outside this research protocol per standard of care

Sponsors & Collaborators

  • Kansas City Heart Rhythm Research Foundation

    lead OTHER

Principal Investigators

  • Naga Venkata K. Pothineni, MD · Kansas City Heart Rhythm Institute

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-22
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Device
Yes

Countries

  • United States

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 NCT06055751 on ClinicalTrials.gov