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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01615835
First Posted: June 11, 2012
Last Update Posted: June 11, 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
Use of the EnSite NavX system to map the coronary vasculature during CRT implant

Condition Intervention
Congestive Heart Failure Other: EnSite NavX System

Study Type: Interventional
Study Design: 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

Further study details as provided by St. Jude Medical:

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

Enrollment: 16
Study Start Date: April 2007
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: EnSite NavX System
    EnSite NavX system is a 3D Mapping system
Detailed Description:

Objective(s):

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.
  Eligibility

Information from the National Library of Medicine

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

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
  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): NCT01615835


Locations
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
Investigators
Principal Investigator: Adam Berman, MD Augusta University
  More Information

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01615835     History of Changes
Other Study ID Numbers: 067.3
First Submitted: December 21, 2007
First Posted: June 11, 2012
Last Update Posted: June 11, 2012
Last Verified: January 2008

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases