EnSite NavX-Guided Coronary Sinus Mapping During CRT Implant (Bi-VNavX)
Use of the EnSite NavX system to map the coronary vasculature during CRT implant
|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|
- Determine feasibility of CS mapping with EnSite NavX during CRT implant [ Time Frame: Procedural ] [ Designated as safety issue: No ]
|Study Start Date:||April 2007|
|Study Completion Date:||October 2007|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
Other: EnSite NavX System
To determine the feasibility of CS mapping with NavX during Biventricular Implantable Cardioverter Defibrillator (BiV ICD) implantation.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|
|Principal Investigator:||Adam Berman, MD||Georgia Regents University|