Status:
RECRUITING
Long Term Evaluation of Cardiac Arrhythmias After Transcatheter Aortic Valve Implantation -The LOCATE Registry
Lead Sponsor:
Kansas City Heart Rhythm Research Foundation
Conditions:
Aortic Stenosis
Atrial Fibrillation New Onset
Eligibility:
All Genders
18+ years
Brief 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 aor...
Detailed Description
Clinical management of the patients that develop conduction system abnormalities not severe enough to warrant a PPM implantation is uncertain due to limited prospective long-term data on outcomes in t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 22 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06055751
Start Date
September 22 2023
End Date
December 1 2025
Last Update
October 16 2024
Active Locations (2)
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1
Research Medical Center Clinic
Kansas City, Missouri, United States, 64032
2
Research Medical Center
Kansas City, Missouri, United States, 64032