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LOCATE Registry for Heart Arrhythmias After TAVI

This study, called the LOCATE Registry, is looking at patients who have undergone a TAVI (Transcatheter Aortic Valve Implantation) procedure for severe aortic stenosis (a narrowing of the heart's aortic valve). Specifically, it focuses on those who develop new heart rhythm problems, like a new left bundle branch block, after their TAVI, but don't immediately need a pacemaker. The study aims to understand how often these patients develop more serious heart block requiring a pacemaker, and how often they experience new atrial fibrillation (an irregular heartbeat) within 12 months after their TAVI. You might be able to join if you are over 18, have severe aortic stenosis, had a TAVI, and developed certain heart rhythm changes afterwards, and had a Boston Scientific Loop Recorder (LUX-Dx) implanted as part of your usual care.

Study design
This is an observational study (a registry) planning to include 50 participants. It will follow patients who have already had a TAVI procedure and a Boston Scientific Loop Recorder (LUX-Dx) implanted.
What's involved
If you participate, your implanted Boston Scientific Loop Recorder (LUX-Dx) will be monitored monthly by your electrophysiology team.
Compensation
Not stated in the trial record.
Follow-up
The study will track the incidence of heart rhythm problems for 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06055751

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

Recruiting
Not specifiedAges 18+Observational
Kansas City Heart Rhythm Research Foundation
~50 participants
Updated 2024-10-16 on ClinicalTrials.gov
What's tested:TAVR Procedure and implantation of Boston Scientific Loop Recorder (LUX-Dx PMA# K193473)

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of brady arrhythmias
Measured over 12 Months
+2 more outcomes measured

Conditions

Aortic Stenosis
Atrial Fibrillation New Onset
Heart Block

Explore related trials

Aortic Valve StenosisAtrial FibrillationHeart block

Where it's being run

2 sites across 1 states
Missouri2

Study leadership

  • Naga Venkata K. Pothineni, MD · PRINCIPAL_INVESTIGATOR · Kansas City Heart Rhythm Institute

Who to contact

Donita Atkins
[email protected]
816-651-1969
Email the study team

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Do you actually qualify for this trial?

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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

What this trial measures

  • Incidence of brady arrhythmias12 Months

    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

  • Predictors of development of late onset heart block needing pacing12 Months

    Evaluate predictors of development of late onset (\>30 days) heart block needing pacing

  • New onset Atrial Fibrillation12 Months

    Assess the incidence of new onset atrial fibrillation post TAVI