EnSite NavX-Guided Coronary Sinus Mapping During CRT Implant (Bi-VNavX)

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. Identifier: NCT01615835
Recruitment Status : Completed
First Posted : June 11, 2012
Last Update Posted : June 11, 2012
Information provided by (Responsible Party):
St. Jude Medical

Brief Summary:
Use of the EnSite NavX system to map the coronary vasculature during CRT implant

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Other: EnSite NavX System Not Applicable

Detailed Description:


To determine the feasibility of CS mapping with NavX during Biventricular Implantable Cardioverter Defibrillator (BiV ICD) implantation.

Inclusion Criteria:

  • Subject is between the age of 18 and 75 years
  • Subject is willing and able to sign a study specific informed consent
  • Subject is able to fulfill study requirements
  • Meet the conventional criteria for implant of a BiV ICD, including; LVEF of ≤35%, QRS ≥ 120 ms and NYHA III-IV
  • Have persistent CHF symptoms despite contemporary CHF medical therapy
  • Stable and optimal medical therapy (stability is no changes in past 3 months).
  • Documented history of ischemic or non-ischemic cardiomyopathy.

Exclusion Criteria:

  • Have any standard device exclusions including tricuspid valve prosthesis/ replacement.
  • Have a positive urine or serum pregnancy test (if female and of childbearing potential)
  • Be currently participating in an IDE or IND study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Mapping in the Coronary Sinus During Implant of a Bi-Ventricular Implantable Cardioverter Defibrillator Utilizing the NavX Mapping System
Study Start Date : April 2007
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Intervention Details:
    Other: EnSite NavX System
    EnSite NavX system is a 3D Mapping system

Primary Outcome Measures :
  1. Determine feasibility of CS mapping with EnSite NavX during CRT implant [ Time Frame: Procedural ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Meet criteria for CRT implant including EF<35%, QRS>120ms, NYHA class III or IV
  • Persistent CHF symptoms despite optimization
  • Stable/optimal medical therapy
  • History of ischemic or non-ischemic cardiomyopathy

Exclusion Criteria:

  • Any standard device exclusion including TVR
  • Positive pregnancy test
  • Currently participating in IDE/IND study

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 identifier (NCT number): NCT01615835

United States, Georgia
Medical College of Georgia
Augusta, Georgia, United States, 30912
United States, North Carolina
Duke Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
St. Jude Medical
Principal Investigator: Adam Berman, MD Augusta University

Responsible Party: St. Jude Medical Identifier: NCT01615835     History of Changes
Other Study ID Numbers: 067.3
First Posted: June 11, 2012    Key Record Dates
Last Update Posted: June 11, 2012
Last Verified: January 2008

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases