Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2025-12-24 @ 10:37 PM
NCT ID:
NCT01615835
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.
Study:
NCT01615835
Study Brief:
Protocol Section:
NCT01615835