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Sponsored by: |
Ohio State University |
Information provided by: | Ohio State University |
ClinicalTrials.gov Identifier: | NCT00708058 |
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 |
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? |
Estimated Enrollment: | 50 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | August 2008 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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
Inclusion Criteria:
Exclusion Criteria:
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 |
Ohio State University |
Principal Investigator: | James Neuenschwander, MD | The Ohio State University Medical Center |
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 |
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