MediGuide Registry

NCT ID: NCT02470312

Last Updated: 2019-02-04

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

578 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-18

Study Completion Date

2018-02-28

Brief Summary

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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

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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

Conditions

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Heart Failure Cardiac Arrhythmia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CRT

Patients who are undergoing CRT implantation utilizing MediGuide system and tools

CRT implantation

Intervention Type PROCEDURE

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

MediGuide

Intervention Type DEVICE

EP

Patients who are undergoing ablation procedures for Atrial Fibrillation, Atrial Flutter, and Ventricular Tachycardia utilizing MediGuide system and tools

MediGuide

Intervention Type DEVICE

EP

Intervention Type PROCEDURE

Interventions

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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 Type PROCEDURE

MediGuide

Intervention Type DEVICE

EP

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kristin Ruffner, PhD

Role: STUDY_DIRECTOR

Abbott

Locations

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John C Lincoln North Mountain Hospital

Phoenix, Arizona, United States

Site Status

Athens Regional Medical Center

Athens, Georgia, United States

Site Status

Gwinnett Medical Center

Lawrenceville, Georgia, United States

Site Status

Central Baptist Hospital

Lexington, Kentucky, United States

Site Status

North Texas Heart Center

Dallas, Texas, United States

Site Status

Memorial Hermann Southwest Hospital

Houston, Texas, United States

Site Status

St. Andrews War Memorial Hospital

East Brisbane, , Australia

Site Status

A. ö. Krankenhaus der Elisabethinen Linz

Linz, , Austria

Site Status

Institut de Cardiologie de Montreal

Montreal, , Canada

Site Status

Tartu University Hospital

Tartu, , Estonia

Site Status

Klinikum Inglostadt

Ingolstadt, , Germany

Site Status

Herzzentrum Leipzig

Leipzig, , Germany

Site Status

Deutsches Herzzentrum München des Freistaates Bayern

München, , Germany

Site Status

Kliniken Villingen-Schwenningen

Villingen-Schwenningen, , Germany

Site Status

Leiden University Medical Center

Leiden, , Netherlands

Site Status

Clinica Universitaria de Navarra

Pamplona, , Spain

Site Status

Countries

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United States Australia Austria Canada Estonia Germany Netherlands Spain

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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10051

Identifier Type: -

Identifier Source: org_study_id

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