MediGuide Registry
- Conditions
- Cardiac ArrhythmiaHeart 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
- Anybody coming for CRT or EP procedure utilizing MediGuide system and tools
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Periprocedural Adverse Event 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
Amount of Fluoroscopy Time Expected time frame is day 1 of the study Amount of fluoroscopy time during CRT implant or EP procedure
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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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
Scroll for more (6 remaining)John C Lincoln North Mountain Hospital🇺🇸Phoenix, Arizona, United States