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Placement of CS/LV Pacing Leads With EnSite NavX Guidance

This study has been withdrawn prior to enrollment.
(Lack of enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00577187
First Posted: December 20, 2007
Last Update Posted: June 12, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
St. Jude Medical
  Purpose
This study utilizes the 3D mapping capabilities of the EnSite NavX mapping system to help guide the placement of the left ventricular lead during cardiovascular resynchronization therapy implant procedures with the goal of reducing fluoroscopic exposure and procedure time.

Condition Intervention Phase
Heart Failure Device: EnSite NavX-Guided CRT implant Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Placement of Coronary Sinus/Left Ventricular Leads With EnSite NavX Guidance

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Fluoroscopy and procedure time [ Time Frame: Procedural ]

Enrollment: 0
Study Start Date: June 2008
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: EnSite NavX-Guided CRT implant
    LV lead placement during CRT implant using EnSite NavX
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients schedule to undergo CRT implant (per established guidelines)

Exclusion Criteria:

  • Standard exclusions to CRT implant procedures
  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): NCT00577187


Locations
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Christopher C Erickson, MD University of Nebraska
  More Information

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00577187     History of Changes
Other Study ID Numbers: 0712.0
First Submitted: December 18, 2007
First Posted: December 20, 2007
Last Update Posted: June 12, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases