NCT02470312

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
578

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2015

Typical duration for all trials

Geographic Reach
6 countries

14 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 12, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

August 18, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
11 months until next milestone

Results Posted

Study results publicly available

January 11, 2019

Completed
Last Updated

February 4, 2019

Status Verified

January 1, 2019

Enrollment Period

1.5 years

First QC Date

April 28, 2015

Results QC Date

June 19, 2018

Last Update Submit

January 31, 2019

Conditions

Heart FailureCardiac Arrhythmia

Keywords

utility of MediGuide systemCRTEP

Outcome Measures

Primary Outcomes (2)

  • Amount of Fluoroscopy Time

    Amount of fluoroscopy time during CRT implant or EP procedure

    Expected time frame is day 1 of the study

  • 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

Study Arms (2)

CRT

Patients who are undergoing CRT implantation utilizing MediGuide system and tools

Procedure: CRT implantationDevice: MediGuide

EP

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

Device: MediGuideProcedure: EP

Interventions

CRT implantationPROCEDURE

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

CRT
MediGuideDEVICE
CRTEP
EPPROCEDURE
EP

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

CRT Group All patients from participating sites who are indicated for a CRT-D/P device implant, including an upgrade with a new left ventricular (LV) lead implant and are implanted with St. Jude Medical pulse generators and willing to provide written Informed Consent can be enrolled in this study. Patients can be implanted with non-St. Jude Medical leads EP Group All patients from participating sites who are indicated for an atrial fibrillation, atrial flutter or ventricular tachycardia (VT) ablation procedure for which market approved MediGuide™-enabled ablation catheter is available and willing to provide written Informed Consent can be enrolled in this study.

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

John C Lincoln North Mountain Hospital

Phoenix, Arizona, 85020, United States

Location

Athens Regional Medical Center

Athens, Georgia, 30606, United States

Location

Gwinnett Medical Center

Lawrenceville, Georgia, 30046, United States

Location

Central Baptist Hospital

Lexington, Kentucky, 40503, United States

Location

North Texas Heart Center

Dallas, Texas, 75231, United States

Location

Memorial Hermann Southwest Hospital

Houston, Texas, United States

Location

St. Andrews War Memorial Hospital

East Brisbane, Australia

Location

A. ö. Krankenhaus der Elisabethinen Linz

Linz, Austria

Location

Institut de Cardiologie de Montreal

Montreal, Canada

Location

Tartu University Hospital

Tartu, Estonia

Location

Klinikum Inglostadt

Ingolstadt, Germany

Location

Herzzentrum Leipzig

Leipzig, Germany

Location

Deutsches Herzzentrum München des Freistaates Bayern

München, Germany

Location

Kliniken Villingen-Schwenningen

Villingen-Schwenningen, Germany

Location

Leiden University Medical Center

Leiden, Netherlands

Location

Clinica Universitaria de Navarra

Pamplona, Spain

Location

MeSH Terms

Conditions

Heart FailureArrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Kristin Ruffner, Clinical Program Director
Organization
Abbott
Kristin.Ruffner@abbott.com
+1 651 756 6717

Study Officials

  • Kristin Ruffner, PhD

    Abbott

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Days
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2015

First Posted

June 12, 2015

Study Start

August 18, 2015

Primary Completion

February 10, 2017

Study Completion

February 28, 2018

Last Updated

February 4, 2019

Results First Posted

January 11, 2019

Record last verified: 2019-01

Locations

US(6)ES(1)AU(1)NL(1)CA(1)DE(4)