EnSite NavX-Guided Coronary Sinus Mapping During CRT Implant

Congestive Heart Failure Clinical Trial

— Bi-VNavX  

Official title:

Mapping in the Coronary Sinus During Implant of a Bi-Ventricular Implantable Cardioverter Defibrillator Utilizing the NavX Mapping System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01615835
• Other study ID #: 067.3
• Status: Completed
• Phase: N/A
• Start date: April 2007
• Est. completion date: October 2007

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Other:
• EnSite NavX System
EnSite NavX system is a 3D Mapping system

Locations

Country	Name	City	State
United States	Medical College of Georgia	Augusta	Georgia
United States	Duke Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine feasibility of CS mapping with EnSite NavX during CRT implant		Procedural