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Clinical Evaluation of Mediguide System in Cardiac Resynchronization Therapy (CRT) Implants

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ClinicalTrials.gov Identifier: NCT01519739
Recruitment Status : Completed
First Posted : January 27, 2012
Last Update Posted : July 20, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to evaluate the safety and performance of the MediGuide™ system during CRT implants.

Condition or disease Intervention/treatment
Heart Failure Device: MediGuide™

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Mediguide System in CRT Implants
Study Start Date : January 2012
Primary Completion Date : May 2012
Study Completion Date : November 2012
Arms and Interventions

Arm Intervention/treatment
Experimental: MediGuide Arm Device: MediGuide™
MediGuide™ system will be used to guide CRT implants


Outcome Measures

Primary Outcome Measures :
  1. The performance of the MediGuide™ system during CRT implant [ Time Frame: 1 month post CRT implant ]
    Performance will be assessed in terms occurence of adverse events, easy of use and potential benefits.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01519739


Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Gerhard Hindricks, MD Herzzentrum Leipzig GmbH
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01519739     History of Changes
Other Study ID Numbers: CR-11-043-EU-MG
First Posted: January 27, 2012    Key Record Dates
Last Update Posted: July 20, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases