MediGuide Registry

Terminated

• Conditions: Cardiac Arrhythmia; Heart Failure
• Interventions: Procedure: CRT implantation; Device: MediGuide; Procedure: EP

• 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

Study Timeline

• Study First Submitted: 2015-04-28
• Study First Submitted QC: 2015-06-11
• Study First Posted: 2015-06-12
• Study Start: 2015-08-18
• Primary Completion: 2017-02-10
• Study Completion: 2018-02-28
• Results First Submitted: 2018-06-19
• Status Verified: 2019-01
• Results First Submitted QC: 2019-01-10
• Results First Posted: 2019-01-11
• Last Update Submitted: 2019-01-31
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 578

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CRT	MediGuide	Patients who are undergoing CRT implantation utilizing MediGuide system and tools
CRT	CRT implantation	Patients who are undergoing CRT implantation utilizing MediGuide system and tools
EP	MediGuide	Patients who are undergoing ablation procedures for Atrial Fibrillation, Atrial Flutter, and Ventricular Tachycardia utilizing MediGuide system and tools
EP	EP	Patients who are undergoing ablation procedures for Atrial Fibrillation, Atrial Flutter, and Ventricular Tachycardia utilizing MediGuide system and tools

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

Trial Locations

Locations (16)

Herzzentrum Leipzig; 🇩🇪 Leipzig, Germany

Kliniken Villingen-Schwenningen; 🇩🇪 Villingen-Schwenningen, Germany

Deutsches Herzzentrum München des Freistaates Bayern; 🇩🇪 München, Germany

Klinikum Inglostadt; 🇩🇪 Ingolstadt, Germany

A. ö. Krankenhaus der Elisabethinen Linz; 🇦🇹 Linz, Austria

Tartu University Hospital; 🇪🇪 Tartu, Estonia

Gwinnett Medical Center; 🇺🇸 Lawrenceville, Georgia, United States

Athens Regional Medical Center; 🇺🇸 Athens, Georgia, United States

St. Andrews War Memorial Hospital; 🇦🇺 East Brisbane, Australia

John C Lincoln North Mountain Hospital; 🇺🇸 Phoenix, Arizona, United States

North Texas Heart Center; 🇺🇸 Dallas, Texas, United States

Central Baptist Hospital; 🇺🇸 Lexington, Kentucky, United States

Memorial Hermann Southwest Hospital; 🇺🇸 Houston, Texas, United States

Institut de Cardiologie de Montreal; 🇨🇦 Montreal, Canada

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands

Clinica Universitaria de Navarra; 🇪🇸 Pamplona, Spain