Placement of CS/LV Pacing Leads With EnSite NavX Guidance

NCT00577187 | Withdrawn Early Phase 1

• 1 other identifier: 0712.0
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Fluoroscopy and procedure time

  Procedural

Interventions

EnSite NavX-Guided CRT implant DEVICE

LV lead placement during CRT implant using EnSite NavX

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Christopher C Erickson, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: December 20, 2007
• Study Start: June 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 4, 2019

Record last verified: 2019-02

Locations

US (1)