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: August 27, 2013
Last verified: August 2013

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: Open Label
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Mediguide System in CRT Implants

Resource links provided by NLM:

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 ] [ Designated as safety issue: No ]
    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
Genders Eligible for Study:   Both
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
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

No publications provided by St. Jude Medical

Additional 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: August 27, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases processed this record on April 14, 2014