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

February 1, 2019 updated by: Abbott Medical Devices

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Medical College of Georgia
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine feasibility of CS mapping with EnSite NavX during CRT implant
Time Frame: Procedural
Procedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: Adam Berman, MD, Augusta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

June 6, 2012

First Posted (Estimate)

June 11, 2012

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 067.3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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