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NCT06055751 · ClinicalTrials.gov registry record
Long Term Evaluation of Cardiac Arrhythmias After Transcatheter Aortic Valve Implantation -The LOCATE Registry
A clinical trial of Aortic Stenosis and Atrial Fibrillation New Onset, sponsored by Kansas City Heart Rhythm Research Foundation.
- Recruiting
- Registry status
- 50
- Enrollment target
- 2
- Study locations
NCT06055751: Recruiting study of Aortic Stenosis and Atrial Fibrillation New Onset, sponsored by Kansas City Heart Rhythm Research Foundation.
NCT06055751 is a study of Aortic Stenosis and Atrial Fibrillation New Onset that is actively recruiting participants, run by Kansas City Heart Rhythm Research Foundation. The registered enrollment target is 50 participants, below the 1,360-participant average among 26 other Aortic Stenosis trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06055751, a study of Aortic Stenosis and Atrial Fibrillation New Onset, is actively recruiting participants, sponsored by Kansas City Heart Rhythm Research Foundation.
- RECRUITING
- Registry status
- 50 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
Incidence of significant brady arrhythmias (2:1 or higher-grade Atrioventricular block (AV) block) requiring pacemaker implantation post TAVI in patients with evidence of conduction system injury following TAVI
Conditions Studied
Interventions
- DEVICE TAVR Procedure and implantation of Boston Scientific Loop Recorder (LUX-Dx PMA# K193473)
Study Locations (2)
Missouri
- Research Medical Center Clinic - Kansas City
- Research Medical Center - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2023-09-22 |
| Est. Completion | 2025-12 |
What NCT06055751 shows while recruiting
NCT06055751 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 1,360-participant average among 26 other Aortic Stenosis trials with a reported enrollment target (96% lower).
The record links to 3 conditions, with Aortic Stenosis appearing as the primary indexed condition, and to 1 intervention - of which TAVR Procedure and implantation of Boston Scientific Loop Recorder (LUX-Dx PMA# K193473) is the first listed.
NCT06055751 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT06055751 about?
NCT06055751 is a clinical study titled "Long Term Evaluation of Cardiac Arrhythmias After Transcatheter Aortic Valve Implantation -The LOCATE Registry". 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 condu...
What is the current status of trial NCT06055751?
This trial is currently recruiting. The enrollment target is 50 participants. The study started on 2023-09-22. Estimated completion is 2025-12.
What conditions does trial NCT06055751 study?
This clinical trial studies the following conditions: Aortic Stenosis, Atrial Fibrillation New Onset, Heart Block.
What interventions are being tested in trial NCT06055751?
The interventions under investigation include: TAVR Procedure and implantation of Boston Scientific Loop Recorder (LUX-Dx PMA# K193473) (DEVICE).
Who is sponsoring clinical trial NCT06055751?
This trial is sponsored by Kansas City Heart Rhythm Research Foundation, which has 22 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06055751 being conducted?
This trial has 2 study locations across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06055751's enrollment target sits among peer trials
50 20th of 26 higher than 7 of 26 other Aortic Stenosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Aortic Stenosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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