Congestive Heart Failure
Conditions
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.
Interventions
OTHEREnSite NavX System
EnSite NavX system is a 3D Mapping system
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine feasibility of CS mapping with EnSite NavX during CRT implant | Procedural |
Countries
United States
Outcome results
None listed