EnSite NavX-Guided Coronary Sinus Mapping During CRT Implant
- Conditions
- Congestive Heart Failure
- Registration Number
- NCT01615835
- Lead Sponsor
- Abbott Medical Devices
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
- 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
- Any standard device exclusion including TVR
- Positive pregnancy test
- Currently participating in IDE/IND study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Determine feasibility of CS mapping with EnSite NavX during CRT implant Procedural
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Duke Medical Center
🇺🇸Durham, North Carolina, United States
Medical College of Georgia
🇺🇸Augusta, Georgia, United States