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

Description

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.

Conditions

Aortic Stenosis, Atrial Fibrillation New Onset, Heart Block

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Aortic Stenosis
Intervention / Treatment

-

Contacts and Locations

Kansas City

Research Medical Center Clinic, Kansas City, Missouri, United States, 64032

Kansas City

Research Medical Center, Kansas City, Missouri, United States, 64032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 within 24 hours
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Kansas City Heart Rhythm Research Foundation,

Naga Venkata K. Pothineni, MD, PRINCIPAL_INVESTIGATOR, Kansas City Heart Rhythm Institute

Study Record Dates

2025-12