Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2026-01-04 @ 10:25 PM
Study NCT ID:
NCT01615835
Status:
COMPLETED
Last Update Posted:
2019-02-04
First Post:
2007-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EnSite NavX-Guided Coronary Sinus Mapping During CRT Implant
Sponsor:
Abbott Medical Devices
Organization:
Study Overview
Official Title:
Mapping in the Coronary Sinus During Implant of a Bi-Ventricular Implantable Cardioverter Defibrillator Utilizing the NavX Mapping System
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Bi-VNavX
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: