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
About this trial
This is an interventional diagnostic trial for Congestive Heart Failure
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
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
NCT ID
NCT01615835
First Posted
December 21, 2007
Last Updated
February 1, 2019
Sponsor
Abbott Medical Devices
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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