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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This study has been withdrawn prior to enrollment.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:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00577187
First received: December 18, 2007
Last updated: June 11, 2012
Last verified: June 2012
History of Changes
  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
 Phase 0

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Placement of Coronary Sinus/Left Ventricular Leads With EnSite NavX Guidance

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:
  • Fluoroscopy and procedure time [ Time Frame: Procedural ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00577187     History of Changes
Other Study ID Numbers: 0712.0
Study First Received: December 18, 2007
Last Updated: June 11, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013