EnSite NavX-Guided Coronary Sinus Mapping During CRT Implant

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2007-10-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Congestive Heart Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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EnSite NavX System

EnSite NavX system is a 3D Mapping system

Intervention Type OTHER

Eligibility Criteria

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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