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Transcatheter aortic valve replacement (TAVR) with Boston Scientific Loop Recorder for Conduction Block

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
No Placebo-Only Group

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
  • Conduction Block
  • Aortic Stenosis
  • Atrial Fibrillation
  • Heart Block

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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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).

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Who is running the clinical trial?

Kansas City Heart Rhythm Research FoundationLead Sponsor
28 Previous Clinical Trials
13,848 Total Patients Enrolled
Naga Venkata K. Pothineni, MDPrincipal InvestigatorKansas City Heart Rhythm Institute
~23 spots leftby Dec 2025