Placement of CS/LV Pacing Leads With EnSite NavX Guidance

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00577187
• Other study ID #: 0712.0
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: June 2008
• Est. completion date: December 2008

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Standard exclusions to CRT implant procedures

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• EnSite NavX-Guided CRT implant
LV lead placement during CRT implant using EnSite NavX

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

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	Fluoroscopy and procedure time		Procedural