Use of Defibrillator Information in the Emergency Department

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ohio State University
ClinicalTrials.gov Identifier:
NCT00708058
First received: June 27, 2008
Last updated: March 19, 2012
Last verified: March 2012
  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

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

Resource links provided by NLM:


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 ]

Enrollment: 50
Study Start Date: August 2007
Study Completion Date: March 2010
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Ohio
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: Brian C Hiestand, MD Ohio State University
  More Information

No publications provided

Responsible Party: Ohio State University
ClinicalTrials.gov Identifier: NCT00708058     History of Changes
Other Study ID Numbers: 2007H0089
Study First Received: June 27, 2008
Last Updated: March 19, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Emergencies
Heart Failure
Disease Attributes
Pathologic Processes
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 24, 2014