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Placement of CS/LV Pacing Leads With EnSite NavX Guidance

Primary Purpose

Heart Failure

Status
Withdrawn
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
EnSite NavX-Guided CRT implant
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients schedule to undergo CRT implant (per established guidelines)

Exclusion Criteria:

  • Standard exclusions to CRT implant procedures

Sites / Locations

  • University of Nebraska Medical Center

Outcomes

Primary Outcome Measures

Fluoroscopy and procedure time

Secondary Outcome Measures

Full Information

First Posted
December 18, 2007
Last Updated
February 1, 2019
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT00577187
Brief Title
Placement of CS/LV Pacing Leads With EnSite NavX Guidance
Official Title
Placement of Coronary Sinus/Left Ventricular Leads With EnSite NavX Guidance
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of enrollment
Study Start Date
June 2008 (undefined)
Primary Completion Date
December 2008 (Anticipated)
Study Completion Date
December 2008 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
EnSite NavX-Guided CRT implant
Intervention Description
LV lead placement during CRT implant using EnSite NavX
Primary Outcome Measure Information:
Title
Fluoroscopy and procedure time
Time Frame
Procedural

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients schedule to undergo CRT implant (per established guidelines) Exclusion Criteria: Standard exclusions to CRT implant procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher C Erickson, MD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States

12. IPD Sharing Statement

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Placement of CS/LV Pacing Leads With EnSite NavX Guidance

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