NCT01615835

Brief Summary

Use of the EnSite NavX system to map the coronary vasculature during CRT implant

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
4.5 years until next milestone

First Posted

Study publicly available on registry

June 11, 2012

Completed
Last Updated

February 4, 2019

Status Verified

February 1, 2019

Enrollment Period

6 months

First QC Date

December 21, 2007

Last Update Submit

February 1, 2019

Conditions

Congestive Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Determine feasibility of CS mapping with EnSite NavX during CRT implant

    Procedural

Interventions

EnSite NavX SystemOTHER

EnSite NavX system is a 3D Mapping system

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meet criteria for CRT implant including EF\<35%, QRS\>120ms, NYHA class III or IV
  • Persistent CHF symptoms despite optimization
  • Stable/optimal medical therapy
  • History of ischemic or non-ischemic cardiomyopathy

You may not qualify if:

  • Positive pregnancy test
  • Currently participating in IDE/IND study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medical College of Georgia

Augusta, Georgia, 30912, United States

Location

Duke Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Adam Berman, MD

    Augusta University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2007

First Posted

June 11, 2012

Study Start

April 1, 2007

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

February 4, 2019

Record last verified: 2019-02

Locations

US(2)