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RECRUITING
NCT06055751

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

Sponsor: Kansas City Heart Rhythm Research Foundation

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2023-09-22

Completion Date

2025-12

Last Updated

2024-10-16

Healthy Volunteers

No

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

Locations (2)

Research Medical Center Clinic

Kansas City, Missouri, United States

Research Medical Center

Kansas City, Missouri, United States