NCT00708058

Brief Summary

This is a study to determine the feasibility of obtaining information stored in existing Medtronic internal defibrillators in patients who present to the Emergency Department(ED) for any reason. In addition, the study will determine if this information is useful to the ED physician in managing the patient's care, specifically as it relates to heart failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 2, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

March 20, 2012

Status Verified

March 1, 2012

Enrollment Period

1.1 years

First QC Date

June 27, 2008

Last Update Submit

March 19, 2012

Conditions

Congestive Heart FailureMedical Device

Keywords

Implanted cardiac defibrillatorsCongestive Heart FailureEmergency Department

Outcome Measures

Primary Outcomes (2)

  • To determine if Medtronic implantable device diagnostics can be used in conjunction with clinical exam to diagnose and guide Emergency Department care

    During Emergency Dept. visit

  • To determine if there are better methods of making the device diagnostic information accessible to ED physicians/staff

    During Emergency Department visit

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients aged 18 or older who present to The Ohio State University Medical Center Emergency Department for any reason, and who have an implanted Medtronic cardiac defibrillator present

You may qualify if:

  • age 18 or older
  • Medtronic IACD present on arrival to Emergency Dept.

You may not qualify if:

  • minors
  • prisoners
  • non-Medtronic AICD
  • unable to provide consent
  • no telephone for 30 day follow up call

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Heart FailureEmergencies

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Brian C Hiestand, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2008

First Posted

July 2, 2008

Study Start

August 1, 2007

Primary Completion

September 1, 2008

Study Completion

March 1, 2010

Last Updated

March 20, 2012

Record last verified: 2012-03

Locations

US(1)