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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02470312
Registration number
NCT02470312
Ethics application status
Date submitted
28/04/2015
Date registered
12/06/2015
Date last updated
4/02/2019
Titles & IDs
Public title
MediGuide Registry
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Scientific title
MediGuide Registry
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Secondary ID [1]
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10051
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Heart Failure
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Cardiac Arrhythmia
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Condition category
Condition code
Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Surgery - CRT implantation
Treatment: Devices - MediGuide
Treatment: Surgery - EP
CRT - Patients who are undergoing CRT implantation utilizing MediGuide system and tools
EP - Patients who are undergoing ablation procedures for Atrial Fibrillation, Atrial Flutter, and Ventricular Tachycardia utilizing MediGuide system and tools
Treatment: Surgery: 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
Treatment: Devices: MediGuide
Treatment: Surgery: EP
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Intervention code [1]
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Treatment: Surgery
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Intervention code [2]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Amount of Fluoroscopy Time
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Assessment method [1]
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Amount of fluoroscopy time during CRT implant or EP procedure
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Timepoint [1]
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Expected time frame is day 1 of the study
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Primary outcome [2]
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Periprocedural Adverse Event
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Assessment method [2]
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Adverse event until patients are discharged from the site center
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Timepoint [2]
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From the day of CRT and EP procedure until patient discharge, expected stay is an average of 3 days
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Eligibility
Key inclusion criteria
- Anybody coming for CRT or EP procedure utilizing MediGuide system and tools
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- None
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/08/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
28/02/2018
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Sample size
Target
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Accrual to date
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Final
578
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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St. Andrews War Memorial Hospital - East Brisbane
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Recruitment postcode(s) [1]
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- East Brisbane
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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Country [2]
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United States of America
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State/province [2]
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Georgia
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Country [3]
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United States of America
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State/province [3]
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Kentucky
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Country [4]
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United States of America
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State/province [4]
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Texas
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Country [5]
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Austria
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State/province [5]
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Linz
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Country [6]
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Canada
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State/province [6]
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Montreal
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Country [7]
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Estonia
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State/province [7]
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Tartu
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Country [8]
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Germany
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State/province [8]
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Ingolstadt
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Country [9]
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Germany
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State/province [9]
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Leipzig
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Country [10]
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Germany
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State/province [10]
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München
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Country [11]
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Germany
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State/province [11]
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Villingen-Schwenningen
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Country [12]
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Netherlands
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State/province [12]
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Leiden
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Country [13]
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Spain
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State/province [13]
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Pamplona
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Abbott Medical Devices
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02470312
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Kristin Ruffner, PhD
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Address
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Abbott
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02470312
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