Placement of CS/LV Pacing Leads With EnSite NavX Guidance

This study is enrolling participants by invitation only.

Sponsored by:	St. Jude Medical
Information provided by:	St. Jude Medical
ClinicalTrials.gov Identifier:	NCT00577187

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

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment
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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	July 2004
Estimated Study Completion Date:	July 2008

Intervention Details:

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

Sponsors and Collaborators

St. Jude Medical

Investigators

Principal Investigator:

Christopher C Erickson, MD

University of Nebraska

More Information

Responsible Party:	St. Jude Medical ( Jihong Qu, PhD )
Study ID Numbers:	0712.0
Study First Received:	December 18, 2007
Last Updated:	December 18, 2007
ClinicalTrials.gov Identifier:	NCT00577187
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009