RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-09-22
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06055751

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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:
  2. * New left bundle branch block (QRS \>120ms)
  3. * New first degree AV block (PR\>200ms) or worsening of pre-existing first-degree AV block by \>30ms
  4. * New right bundle branch block (QRS\>120ms)
  5. * Intra-procedural 2:1 or higher-grade AV block with spontaneous improvement within 24 hours
  1. * Patients with high grade or complete AV block post TAVI needing urgent pacemakers
  2. * Patient with existing cardiac implantable electronic devices (CIEDs)
  3. * Patients having a particular medical condition that dictates that they cannot tolerate subcutaneous, chronically-inserted device
  4. * 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).
  5. * Patients not willing to sign the consent, lacks the capacity to sign the consent or revoke the consent after signing will be excluded

Contacts and Locations

Study Contact

Donita Atkins
CONTACT
816-651-1969
datkins@kchrf.com

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Kansas City Heart Rhythm Research Foundation

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-22
Study Completion Date2025-12

Study Record Updates

Study Start Date2023-09-22
Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

  • Aortic Stenosis
  • Atrial Fibrillation New Onset
  • Heart Block