Incidence and management of atrioventricular conduction disorders in new-onset left bundle branch block after TAVI: A prospective multicenter study.
Grégoire Massoullié, Sylvain Ploux, Géraud Souteyrand...
https://pubmed.ncbi.nlm.nih.gov/36646235Actively Recruiting
Age: 18Years +
All Genders
ID06055751
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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are observing patients with severe aortic stenosis who have undergone transcatheter aortic valve implantation (TAVI) and developed new conduction system abnormalities that do not require urgent permanent pacemaker implantation. The study aims to understand the long-term occurrence of heart block that may need pacemakers later and the development of new atrial fibrillation after TAVI. This research hopes to improve knowledge and treatment for patients with these heart conditions.
CONDITIONS
Brief Title
Long Term Evaluation of Cardiac Arrhythmias After Transcatheter Aortic Valve Implantation -The LOCATE Registry
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients over 18 years old with severe aortic stenosis who have undergone TAVI
- Development of new conduction abnormalities after TAVI, including 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 Boston Scientific Loop Recorder for long-term monitoring
You will not qualify if you...
- Patients requiring urgent permanent pacemaker implantation due to high-grade or complete AV block after TAVI
- Patients with existing cardiac implantable electronic devices
- Patients unable to tolerate subcutaneous, chronically-inserted devices due to medical conditions
- Currently pregnant patients (positive urine Beta-HCG test)
- Patients unwilling or unable to provide informed consent or who revoke consent after signing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Up to 12 months
Participants have a Boston Scientific Loop Recorder implanted as part of their routine care after undergoing transcatheter aortic valve implantation (TAVI).
Monthly monitoring visits
Long-term Monitoring
Duration - Up to 12 months
Participants are monitored for cardiac arrhythmias and conduction abnormalities through the implanted loop recorder, with monthly reviews by the electrophysiology team.
Monthly visits for device monitoring and evaluation
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
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Research Team
D
Donita Atkins
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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Published Research Related To This Trial
2020 ACC Expert Consensus Decision Pathway on Management of Conduction Disturbances in Patients Undergoing Transcatheter Aortic Valve Replacement: A Report of the American College of Cardiology Solution Set Oversight Committee.
Scott M Lilly, Abhishek J Deshmukh, Andrew E Epstein...
https://pubmed.ncbi.nlm.nih.gov/33190683