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

This study is not yet open for participant recruitment.
Verified January 2012 by St. Jude Medical
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01519739
First received: January 18, 2012
Last updated: January 26, 2012
Last verified: January 2012
History of Changes
  Purpose

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:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

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.


Estimated Enrollment: 15
Study Start Date: January 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: MediGuide™
    MediGuide™ system will be used to guide CRT implants
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01519739

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

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01519739     History of Changes
Other Study ID Numbers: CR-11-043-EU-MG
Study First Received: January 18, 2012
Last Updated: January 26, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013