MediGuide Registry

Heart Failure Clinical Trial

Official title:

MediGuide Registry

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02470312
• Other study ID #: 10051
• Status: Terminated
• Start date: August 18, 2015
• Est. completion date: February 28, 2018

Study information

• Verified date: January 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 578
• Est. completion date: February 28, 2018
• Est. primary completion date: February 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia
• Heart Failure

Intervention

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

Procedure:
• EP

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  Estonia,  Germany,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of Fluoroscopy Time	Amount of fluoroscopy time during CRT implant or EP procedure	Expected time frame is day 1 of the study
Primary	Periprocedural Adverse Event	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