RecruitingNCT06055751

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

Sponsor

Kansas City Heart Rhythm Research Foundation

Enrollment

50 participants

Start Date

Sep 22, 2023

Study Type

OBSERVATIONAL

Conditions

Aortic Stenosis Heart Block Atrial Fibrillation New Onset

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 within 24 hours

Exclusion Criteria5

Patients with high grade or complete AV block post TAVI needing urgent pacemakers
Patient with existing cardiac implantable electronic devices (CIEDs)
Patients having a particular medical condition that dictates that they cannot tolerate subcutaneous, chronically-inserted device
Patient is currently pregnant as evidenced by urine positive Beta-HCG. (Urine Beta human chorionic gonadotropin (HCG) will be checked in all females of the reproductive age group).
Patients not willing to sign the consent, lacks the capacity to sign the consent or revoke the consent after signing will be excluded

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