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

Recruiting at 1 trial location

Overseen By Donita Atkins

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kansas City Heart Rhythm Research Foundation

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Naga Venkata K. Pothineni, MD

Principal Investigator

Kansas City Heart Rhythm Institute

Eligibility Criteria

Inclusion Criteria

You have developed a new left bundle branch block, with the electrical impulse taking more than 120 milliseconds to travel.

You have developed a new first-degree AV block with PR greater than 200 milliseconds, or your pre-existing first degree AV block has deteriorated by more than 30 milliseconds.

You have a newly developed right bundle branch block, with an electrical conduction time of more than 120 milliseconds.

Treatment Details

Participant Groups

Group I: Transcatheter aortic valve replacement (TAVR) with Boston Scientific Loop Recorder Experimental Treatment 1 Intervention

This is a group of patients who have undergone TAVI procedure and implantation of Boston Scientific Loop Recorder (LUX-Dx PMA# K193473).

Who Is Running the Clinical Trial?

Kansas City Heart Rhythm Research Foundation

Lead Sponsor

Trials

30

Recruited

14,000+