EnSite NavX-Guided Coronary Sinus Mapping During CRT Implant (Bi-VNavX)

Abbott

Status: Completed

Conditions: Congestive Heart Failure

Treatments: Other: EnSite NavX System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01615835

067.3

Details and patient eligibility

About

Use of the EnSite NavX system to map the coronary vasculature during CRT implant

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)