NCT06055751

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Kansas City Heart Rhythm Research Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 implantation with very sparse data on longer term outcomes. In addition to conduction system abnormalities, other arrhythmias such as AF following TAVI have also been shown to be associated with worse long-term outcomes. However, prospective data on incidence and risk factors of post TAVI atrial fibrillation is limited. This will be a prospective observational study (Registry). Patients that have undergone a TAVI procedure and meet inclusion and no exclusion criteria will be approached about participating in the study. Patients who have undergone Boston Scientific Loop Recorder (LUX-Dx Premarket Approval Application (PMA)# K193473) as standard of care for arrhythmia monitoring after TAVI will have the ILR monitored monthly by the electrophysiology team. All alerts will be reviewed and discussed with the implanting physician for further management. Patients will be followed for up to 12 months.

Conditions

• Aortic Stenosis
• Atrial Fibrillation New Onset
• Heart Block

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-09-22
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2023-09-28
• Last updated: 2024-10-16

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study