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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01615835
First received: December 21, 2007
Last updated: June 6, 2012
Last verified: January 2008
  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: 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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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 Georgia Regents University
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01615835     History of Changes
Other Study ID Numbers: 067.3
Study First Received: December 21, 2007
Last Updated: June 6, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014