Actively Recruiting
Long Term Evaluation of Cardiac Arrhythmias After Transcatheter Aortic Valve Implantation -The LOCATE Registry
Led by Kansas City Heart Rhythm Research Foundation · Updated on 2024-10-16
50
Participants Needed
2
Research Sites
114 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Long Term Evaluation of Cardiac Arrhythmias After Transcatheter Aortic Valve Implantation -The LOCATE Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients over 18 years old with severe aortic stenosis who underwent TAVI
- Development of any of these conduction abnormalities on post-procedure ECG: 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
- Underwent implantation of a Boston Scientific Loop Recorder for long-term monitoring
You will not qualify if you...
- Patients with high-grade or complete AV block after TAVI needing urgent pacemaker implantation
- Patients who already have cardiac implantable electronic devices
- Patients with medical conditions preventing tolerance of a subcutaneous, chronically-inserted device
- Pregnant patients (confirmed by positive urine Beta-HCG test)
- Patients unwilling or unable to provide informed consent or who revoke consent after signing
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Research Medical Center Clinic
Kansas City, Missouri, United States, 64032
Actively Recruiting
2
Research Medical Center
Kansas City, Missouri, United States, 64032
Actively Recruiting
Research Team
D
Donita Atkins
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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