MedPath

MediGuide Registry

Terminated
Conditions
Cardiac Arrhythmia
Heart Failure
Registration Number
NCT02470312
Lead Sponsor
Abbott Medical Devices
Brief Summary

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.

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

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
578
Inclusion Criteria
  • Anybody coming for CRT or EP procedure utilizing MediGuide system and tools
Exclusion Criteria
  • None

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Periprocedural Adverse EventFrom 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

Amount of Fluoroscopy TimeExpected time frame is day 1 of the study

Amount of fluoroscopy time during CRT implant or EP procedure

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (16)

John C Lincoln North Mountain Hospital

🇺🇸

Phoenix, Arizona, United States

Athens Regional Medical Center

🇺🇸

Athens, Georgia, United States

Gwinnett Medical Center

🇺🇸

Lawrenceville, Georgia, United States

Central Baptist Hospital

🇺🇸

Lexington, Kentucky, United States

North Texas Heart Center

🇺🇸

Dallas, Texas, United States

Memorial Hermann Southwest Hospital

🇺🇸

Houston, Texas, United States

St. Andrews War Memorial Hospital

🇦🇺

East Brisbane, Australia

A. ö. Krankenhaus der Elisabethinen Linz

🇦🇹

Linz, Austria

Institut de Cardiologie de Montreal

🇨🇦

Montreal, Canada

Tartu University Hospital

🇪🇪

Tartu, Estonia

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John C Lincoln North Mountain Hospital
🇺🇸Phoenix, Arizona, United States

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