This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by (Responsible Party):
St. Jude Medical Identifier:
First received: January 18, 2012
Last updated: July 19, 2016
Last verified: July 2016
The purpose of this study is to evaluate the safety and performance of the MediGuide™ system during CRT implants.

Condition Intervention
Heart Failure Device: MediGuide™

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Mediguide System in CRT Implants

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • 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.

Enrollment: 15
Study Start Date: January 2012
Study Completion Date: November 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MediGuide Arm Device: MediGuide™
MediGuide™ system will be used to guide CRT implants


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01519739

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

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: St. Jude Medical Identifier: NCT01519739     History of Changes
Other Study ID Numbers: CR-11-043-EU-MG
Study First Received: January 18, 2012
Last Updated: July 19, 2016

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases processed this record on August 17, 2017