Trial Review

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
MediGuide Registry
Secondary ID [1] 0 0
10051
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Cardiac Arrhythmia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Surgery - CRT implantation

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
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Amount of Fluoroscopy Time
Timepoint [1] 0 0
Expected time frame is day 1 of the study
Primary outcome [2] 0 0
Periprocedural Adverse Event
Timepoint [2] 0 0
From the day of CRT and EP procedure until patient discharge, expected stay is an average of 3 days

Eligibility
Key inclusion criteria
* Anybody coming for CRT or EP procedure utilizing MediGuide system and tools
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* None

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/08/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/02/2018
Sample size
Target
Accrual to date
Final
578
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
St. Andrews War Memorial Hospital - East Brisbane
Recruitment postcode(s) [1] 0 0
- East Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Kentucky
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
Austria
State/province [5] 0 0
Linz
Country [6] 0 0
Canada
State/province [6] 0 0
Montreal
Country [7] 0 0
Estonia
State/province [7] 0 0
Tartu
Country [8] 0 0
Germany
State/province [8] 0 0
Ingolstadt
Country [9] 0 0
Germany
State/province [9] 0 0
Leipzig
Country [10] 0 0
Germany
State/province [10] 0 0
München
Country [11] 0 0
Germany
State/province [11] 0 0
Villingen-Schwenningen
Country [12] 0 0
Netherlands
State/province [12] 0 0
Leiden
Country [13] 0 0
Spain
State/province [13] 0 0
Pamplona

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kristin Ruffner, PhD
Address 0 0
Abbott
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

TypeOther DetailsAttachment
Study protocol Study Protocol and Statistical Analysis Plan
Statistical analysis plan Study Protocol and Statistical Analysis Plan



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02470312