Clinical Evaluation of Mediguide System in Cardiac Resynchronization Therapy (CRT) Implants
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MediGuide™
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Meet clinical indication for implantation of an SJM CRT system according to the current European Society of Cardiology (ESC) Guidelines for cardiac and resynchronization therapy
- Receiving a new implant or undergoing an upgrade from an existing ICD or pacemaker implant with no prior LV lead placement
- Ability to provide informed consent for study participation and are willing and able to comply with the prescribed follow-up tests and schedule of evaluations
Exclusion Criteria:
- Currently participating in any other clinical study
- Have prosthetic valves
- Are pregnant or planning pregnancy in the next 1 month
- Are less than 18 years of age
- Have ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MediGuide Arm
Arm Description
Outcomes
Primary Outcome Measures
The performance of the MediGuide™ system during CRT implant
Performance will be assessed in terms occurence of adverse events, easy of use and potential benefits.
Secondary Outcome Measures
Full Information
NCT ID
NCT01519739
First Posted
January 18, 2012
Last Updated
October 28, 2019
Sponsor
Abbott Medical Devices
1. Study Identification
Unique Protocol Identification Number
NCT01519739
Brief Title
Clinical Evaluation of Mediguide System in Cardiac Resynchronization Therapy (CRT) Implants
Official Title
Clinical Evaluation of Mediguide System in CRT Implants
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and performance of the MediGuide™ system during CRT implants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MediGuide Arm
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
MediGuide™
Intervention Description
MediGuide™ system will be used to guide CRT implants
Primary Outcome Measure Information:
Title
The performance of the MediGuide™ system during CRT implant
Description
Performance will be assessed in terms occurence of adverse events, easy of use and potential benefits.
Time Frame
1 month post CRT implant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Meet clinical indication for implantation of an SJM CRT system according to the current European Society of Cardiology (ESC) Guidelines for cardiac and resynchronization therapy
Receiving a new implant or undergoing an upgrade from an existing ICD or pacemaker implant with no prior LV lead placement
Ability to provide informed consent for study participation and are willing and able to comply with the prescribed follow-up tests and schedule of evaluations
Exclusion Criteria:
Currently participating in any other clinical study
Have prosthetic valves
Are pregnant or planning pregnancy in the next 1 month
Are less than 18 years of age
Have ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Hindricks, MD
Organizational Affiliation
Herzzentrum Leipzig GmbH
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
24002003
Citation
Richter S, Doring M, Gaspar T, John S, Rolf S, Sommer P, Hindricks G, Piorkowski C. Cardiac resynchronization therapy device implantation using a new sensor-based navigation system: results from the first human use study. Circ Arrhythm Electrophysiol. 2013 Oct;6(5):917-23. doi: 10.1161/CIRCEP.113.000066. Epub 2013 Sep 3.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/24002003
Description
Published paper (Circ Arrhythm Electrophysiol, 2013) for a feasibility study
Learn more about this trial
Clinical Evaluation of Mediguide System in Cardiac Resynchronization Therapy (CRT) Implants
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