Long Term Evaluation of Cardiac Arrhythmias After Transcatheter Aortic Valve Implantation -The LOCATE Registry
Kansas City Heart Rhythm Research Foundation
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.
Description
Clinical management of the patients that develop conduction system abnormalities not severe enough to warrant a PPM implantation is uncertain due to limited prospective long-term data on outcomes in this patient population with significant variations in treatment approaches. While some electrophysiologists favor ambulatory monitoring with event monitors or Implantable loop recorder (ILR), small studies have shown a potential benefit of invasive electrophysiological studies for risk stratification. Most rhythm monitoring studies have only focused on arrhythmias in the first 2-4 weeks post impla…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients \> 18 years of age with severe aortic stenosis that undergo TAVI for severe aortic stenosis that develop any one of the following conduction system abnormalities on the immediate post procedural or post operative ECG and have undergone ILR implantation for long-term monitoring of these conditions: * New left bundle branch block (QRS \>120ms) * New first degree AV block (PR\>200ms) or worsening of pre-existing first-degree AV block by \>30ms * New right bundle branch block (QRS\>120ms) * Intra-procedural 2:1 or higher-grade AV block with spontaneous improvement w…
Interventions
- DeviceTAVR 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 ClinicKansas City, Missouri
- Research Medical CenterKansas City, Missouri