RecruitingNCT06055751

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


Sponsor

Kansas City Heart Rhythm Research Foundation

Enrollment

50 participants

Start Date

Sep 22, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is a registry that tracks patients who received a heart valve replacement procedure called TAVI (transcatheter aortic valve implantation) and then developed heart rhythm problems (conduction abnormalities). Participants have an implantable heart monitor (loop recorder) placed to track their heart rhythm long-term. **You may be eligible if...** - You are over 18 years old with severe aortic stenosis (a narrowing of the heart valve) - You have undergone TAVI and developed one of these heart rhythm issues afterward: new left bundle branch block, new first-degree AV block, new right bundle branch block, or temporary higher-degree AV block during the procedure - You have already had a small implantable loop recorder (ILR) placed for long-term heart monitoring **You may NOT be eligible if...** - You need a permanent pacemaker urgently after TAVI - You already have an implantable cardiac device (pacemaker, ICD) - You cannot comply with follow-up visits Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETAVR Procedure and implantation of Boston Scientific Loop Recorder (LUX-Dx PMA# K193473)

No intervention will be done as part of this prospective registry. Implantation of Boston Scientific Loop Recorder (LUX-Dx) will be performed regardless of this research and outside this research protocol per standard of care


Locations(2)

Research Medical Center Clinic

Kansas City, Missouri, United States

Research Medical Center

Kansas City, Missouri, United States

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NCT06055751


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