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Use of Defibrillator Information in the Emergency Department

This study is currently recruiting participants.
Verified by Ohio State University, June 2008

Sponsored by: Ohio State University
Information provided by: Ohio State University
ClinicalTrials.gov Identifier: NCT00708058
  Purpose

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.


Condition
Congestive Heart Failure
Medical Device

MedlinePlus related topics:   Heart Failure   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Other, Prospective
Official Title:   Can Pacemakers, Defibrillators, and Internal Heart Failure Devices Be Used to Evaluate and Guide Management in the Emergency Department?

Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • To determine if Medtronic implantable device diagnostics can be used in conjunction with clinical exam to diagnose and guide Emergency Department care [ Time Frame: During Emergency Dept. visit ] [ Designated as safety issue: No ]
  • To determine if there are better methods of making the device diagnostic information accessible to ED physicians/staff [ Time Frame: During Emergency Department visit ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:   50
Study Start Date:   August 2007
Estimated Study Completion Date:   August 2008

Detailed Description:

This is a prospective observational pilot study to determine if stored data regarding heart function, patient activity level, and other parameters can be used by the ED physician in order to evaluate a patient's cardiac status as it pertains to heart failure. Patients presenting to the ED and who consent have their devices interrogated by research personnel. The data is printed and provided to the treating physician who completes a brief survey about whether the data was useful in managing the patient.All subjects are contacted 30 days after ED or hospital discharge to determine if they have had any ED visits or hospital admissions during that period, and if yes, whether the visits were heart failure related. After all study procedures are performed, a team of 2 cardiologists will review the patient medical record from the study visit, as well as the data obtained from the patient's device in the ED. Each cardiologist, who will be blinded to the other's conclusion, will determine if the patient was having a heart failure exacerbation at the study visit.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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


Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00708058

Locations
United States, Ohio
The Ohio State University Medical Center     Recruiting
      Columbus, Ohio, United States, 43210
      Contact: James F Neuenschwander, MD     614-293-8305     james.neuenschwander@osumc.edu    
      Principal Investigator: James F Neuenschwander, MD            

Sponsors and Collaborators
Ohio State University

Investigators
Principal Investigator:     James Neuenschwander, MD     The Ohio State University Medical Center    
  More Information


Responsible Party:   The Ohio State University Dept. of Emergency Medicine ( James F. Neuenschwander II )
Study ID Numbers:   2007H0089
First Received:   June 27, 2008
Last Updated:   June 27, 2008
ClinicalTrials.gov Identifier:   NCT00708058
Health Authority:   United States: Institutional Review Board

Keywords provided by Ohio State University:
Implanted cardiac defibrillators  
Congestive Heart Failure  
Emergency Department  

Study placed in the following topic categories:
Heart Failure
Heart Diseases
Emergencies

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 04, 2008




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