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

Primary Purpose

Congestive Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EnSite NavX System
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Congestive Heart Failure

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical College of Georgia
  • Duke Medical Center

Outcomes

Primary Outcome Measures

Determine feasibility of CS mapping with EnSite NavX during CRT implant

Secondary Outcome Measures

Full Information

First Posted
December 21, 2007
Last Updated
February 1, 2019
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT01615835
Brief Title
EnSite NavX-Guided Coronary Sinus Mapping During CRT Implant
Acronym
Bi-VNavX
Official Title
Mapping in the Coronary Sinus During Implant of a Bi-Ventricular Implantable Cardioverter Defibrillator Utilizing the NavX Mapping System
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
EnSite NavX System
Intervention Description
EnSite NavX system is a 3D Mapping system
Primary Outcome Measure Information:
Title
Determine feasibility of CS mapping with EnSite NavX during CRT implant
Time Frame
Procedural

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Berman, MD
Organizational Affiliation
Augusta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Duke Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Learn more about this trial

EnSite NavX-Guided Coronary Sinus Mapping During CRT Implant

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