Placement of CS/LV Pacing Leads With EnSite NavX Guidance | NCT00577187

Studies
Placement of CS/LV Pacing Leads With EnSite NavX Guidance

NCT00577187

Sponsor

Abbott Medical Devices

Status

Withdrawn

Last Update Posted

Feb 4, 2019Actual

Enrollment

0Actual

Phase

Early Phase 1

Conditions

Heart Failure

Interventions

EnSite NavX-Guided CRT implant

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of enrollment

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Dec 2008Estimated

Completion Date

Dec 2008Estimated

First Submitted Date

Dec 18, 2007

First Submission Date that Met QC Criteria

Dec 18, 2007

First Posted Date

Dec 20, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 1, 2019

Last Update Posted Date

Feb 4, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EnSite NavX-Guided CRT implant	Device	LV lead placement during CRT implant using EnSite NavX

Measure	Description	Time Frame
Fluoroscopy and procedure time		Procedural

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients schedule to undergo CRT implant (per established guidelines)

Exclusion Criteria:

Standard exclusions to CRT implant procedures

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christopher C Erickson, MD	University of Nebraska	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Nebraska Medical Center		Omaha	Nebraska	68198	United States

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided