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

StatusRecruiting
PhaseNot specified
Started2023-09-22
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 16, 2024 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
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.

Amendment record

Amended 3 times since 2023-09-20; most recent filed 2024-10-14. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-30.

2024-10-14
Amendment Study Status v3
2023-10-13
Amendment Study Status v2
2023-09-26
Amendment Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility v1
2023-09-20
Original filing
Trial Details
NCT Number NCT06055751
Lead Sponsor Kansas City Heart Rhythm Research Foundation
Conditions Aortic Stenosis, Atrial Fibrillation New Onset, Heart Block
Enrollment 50 participants
Start Date 2023-09-22
Primary Completion 2025-12 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2024-10-16