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Transcatheter aortic valve replacement (TAVR) with Boston Scientific Loop Recorder for Aortic Stenosis

N/A
Recruiting
Led By Naga Venkata K. Pothineni, MD
Research Sponsored by Kansas City Heart Rhythm Research Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

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.

Eligible Conditions
  • Aortic Stenosis
  • Heart Block
  • Atrial Fibrillation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of brady arrhythmias
New onset Atrial Fibrillation
Predictors of development of late onset heart block needing pacing

Trial Design

1Treatment groups
Experimental Treatment
Group I: Transcatheter aortic valve replacement (TAVR) with Boston Scientific Loop RecorderExperimental Treatment1 Intervention
This is a group of patients who have undergone TAVI procedure and implantation of Boston Scientific Loop Recorder (LUX-Dx PMA# K193473).

Find a Location

Who is running the clinical trial?

Kansas City Heart Rhythm Research FoundationLead Sponsor
26 Previous Clinical Trials
11,922 Total Patients Enrolled
Naga Venkata K. Pothineni, MDPrincipal InvestigatorKansas City Heart Rhythm Institute

Frequently Asked Questions

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~33 spots leftby Dec 2025