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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Missouri
Research Medical Center
RECRUITING
Kansas City
Research Medical Center Clinic
RECRUITING
Kansas City
Contact Information
Primary
Donita Atkins
datkins@kchrf.com
816-651-1969
Time Frame
Start Date: 2023-09-22
Estimated Completion Date: 2025-12
Participants
Target number of participants: 50
Treatments
Transcatheter aortic valve replacement (TAVR) with Boston Scientific Loop Recorder
This is a group of patients who have undergone TAVI procedure and implantation of Boston Scientific Loop Recorder (LUX-Dx PMA# K193473).
Sponsors
Leads: Kansas City Heart Rhythm Research Foundation

This content was sourced from clinicaltrials.gov