MediGuide Registry

January 31, 2019 updated by: Abbott Medical Devices
The goal of this registry/observational study is to collect data on the clinical utility of MediGuide™ system in cardiac resynchronization therapy (CRT) implantation and electrophysiology (EP) procedures.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The intent of this worldwide registry/observational study is to understand the utility of the MediGuide™ technology in real world clinical practice during CRT implantation and study-specific-EP procedures. The study should provide an understanding of the effect of MediGuide™ technology on:

  • The amount of fluoroscopy time and the radiation exposure
  • Total procedure time
  • Peri-procedural clinical event rate

Additionally, this study will address the following

  • Identification of procedural challenges which may aid in developing future MediGuide tools
  • Evaluation of newly available MediGuide tools during the study
  • Correlation between MediGuide operator experience and the radiation exposure amount and time

Study Type

Observational

Enrollment (Actual)

578

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • East Brisbane, Australia
        • St. Andrews War Memorial Hospital
  • Austria
      • Linz, Austria
        • A. ö. Krankenhaus der Elisabethinen Linz
  • Canada
      • Montreal, Canada
        • Institut de Cardiologie de Montreal
  • Estonia
      • Tartu, Estonia
        • Tartu University Hospital
  • Germany
      • Ingolstadt, Germany
        • Klinikum Inglostadt
      • Leipzig, Germany
        • Herzzentrum Leipzig
      • München, Germany
        • Deutsches Herzzentrum München des Freistaates Bayern
      • Villingen-Schwenningen, Germany
        • Kliniken Villingen-Schwenningen
  • Netherlands
      • Leiden, Netherlands
        • Leiden University Medical Center
  • Spain
      • Pamplona, Spain
        • Clinica Universitaria de Navarra
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85020
        • John C Lincoln North Mountain Hospital
    • Georgia
      • Athens, Georgia, United States, 30606
        • Athens Regional Medical Center
      • Lawrenceville, Georgia, United States, 30046
        • Gwinnett Medical Center
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Central Baptist Hospital
    • Texas
      • Dallas, Texas, United States, 75231
        • North Texas Heart Center
      • Houston, Texas, United States
        • Memorial Hermann Southwest Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

CRT Group All patients from participating sites who are indicated for a CRT-D/P device implant, including an upgrade with a new left ventricular (LV) lead implant and are implanted with St. Jude Medical pulse generators and willing to provide written Informed Consent can be enrolled in this study. Patients can be implanted with non-St. Jude Medical leads

EP Group All patients from participating sites who are indicated for an atrial fibrillation, atrial flutter or ventricular tachycardia (VT) ablation procedure for which market approved MediGuide™-enabled ablation catheter is available and willing to provide written Informed Consent can be enrolled in this study.

Description

Inclusion Criteria:

  • Anybody coming for CRT or EP procedure utilizing MediGuide system and tools

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CRT
Patients who are undergoing CRT implantation utilizing MediGuide system and tools
Procedure: CRT implantation
It is a novel 3D electromagnetic navigation system (MediGuide™) that is capable of non-fluoroscopic navigation of sensor-enabled tools in the x-ray environment
Device: MediGuide
EP
Patients who are undergoing ablation procedures for Atrial Fibrillation, Atrial Flutter, and Ventricular Tachycardia utilizing MediGuide system and tools
Device: MediGuide
Procedure: EP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of Fluoroscopy Time
Time Frame: Expected time frame is day 1 of the study
Amount of fluoroscopy time during CRT implant or EP procedure
Expected time frame is day 1 of the study
Periprocedural Adverse Event
Time Frame: From the day of CRT and EP procedure until patient discharge, expected stay is an average of 3 days
Adverse event until patients are discharged from the site center
From the day of CRT and EP procedure until patient discharge, expected stay is an average of 3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 18, 2015

Primary Completion (Actual)

February 10, 2017

Study Completion (Actual)

February 28, 2018

Study Registration Dates

First Submitted

April 28, 2015

First Submitted That Met QC Criteria

June 11, 2015

First Posted (Estimate)

June 12, 2015

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10051 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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