Placement of CS/LV Pacing Leads With EnSite NavX Guidance

February 1, 2019 updated by: Abbott Medical Devices

Placement of Coronary Sinus/Left Ventricular Leads With EnSite NavX Guidance

This study utilizes the 3D mapping capabilities of the EnSite NavX mapping system to help guide the placement of the left ventricular lead during cardiovascular resynchronization therapy implant procedures with the goal of reducing fluoroscopic exposure and procedure time.

Study Overview

Status

Withdrawn

Conditions

Heart Failure

Intervention / Treatment

Device: EnSite NavX-Guided CRT implant

Study Type

Interventional

Phase

Early Phase 1

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
- Nebraska
  - Omaha, Nebraska, United States, 68198
    - University Of Nebraska 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

ADULT
OLDER_ADULT
CHILD

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients schedule to undergo CRT implant (per established guidelines)

Exclusion Criteria:

Standard exclusions to CRT implant procedures

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: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Fluoroscopy and procedure time 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: Christopher C Erickson, MD, University of Nebraska

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

June 1, 2008

Primary Completion (ANTICIPATED)

December 1, 2008

Study Completion (ANTICIPATED)

December 1, 2008

Study Registration Dates

First Submitted

December 18, 2007

First Submitted That Met QC Criteria