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

Part of paid clinical trials in Kansas City, Missouri.

Sponsor
Kansas City Heart Rhythm Research Foundation
Study ID
NCT06055751
Status
Recruiting
Apply to this trial

Conditions

  • Aortic Stenosis
  • Atrial Fibrillation New Onset
  • Heart Block

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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 Dates

Start date
Sep 22, 2023
Status verified
Oct 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Transcatheter aortic valve replacement (TAVR) with Boston Scientific Loop Recorder
    This is a group of patients who have undergone TAVI procedure and implantation of Boston Scientific Loop Recorder (LUX-Dx PMA# K193473).

Primary Outcome Measure

Incidence of brady arrhythmias [ Time Frame: 12 Months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Research Medical CenterKansas CityMissouri64032
Donita Atkins
[email protected]
816-651-1969
Naga Venkata K. Pothineni, MD (PRINCIPAL_INVESTIGATOR)
Research Medical Center ClinicKansas CityMissouri64032
Donita Atkins
[email protected]
816-651-1969
Naga Venkata K. Pothineni, MD (PRINCIPAL_INVESTIGATOR)

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