Congestive Heart FailureNCT00708058
Use of Defibrillator Information in the Emergency Department
An observational study of Congestive Heart Failure and Medical Device, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure, Medical Device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Mar 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- age 18 or older
- Medtronic IACD present on arrival to Emergency Dept.
Who cannot join
- minors
- prisoners
- non-Medtronic AICD
- unable to provide consent
- no telephone for 30 day follow up call
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
Official title: Can Pacemakers, Defibrillators, and Internal Heart Failure Devices Be Used to Evaluate and Guide Management in the Emergency Department?
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.
Read the 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.
- Conditions
- Congestive Heart Failure, Medical Device
- Keywords
- Implanted cardiac defibrillators, Congestive Heart Failure, Emergency Department
- Medical subject headings
- Heart Failure, Emergencies
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if Medtronic implantable device diagnostics can be used in conjunction with clinical exam to diagnose and guide Emergency Department care
Measured: During Emergency Dept. visit
To determine if there are better methods of making the device diagnostic information accessible to ED physicians/staff
Measured: During Emergency Department visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2008 (estimated)
- Study startAug 2007
- Primary completionSep 2008
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian C Hiestand, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00708058
- Sponsor's protocol ID
- 2007H0089
- Status last verified
- Mar 2012
- First submitted
- 27 Jun 2008
- Last updated
- 20 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Pacemakers, Defibrillators, and Internal Heart Failure Devices Be Used to Evaluate and Guide Management in the Emergency Department?
- ClinicalTrials.gov ID
- NCT00708058
- Acronym / sponsor ID
- 2007H0089
- Conditions
- Congestive Heart Failure, Medical Device
- Keywords
- Implanted cardiac defibrillators, Congestive Heart Failure, Emergency Department
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 2 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- age 18 or older
- Medtronic IACD present on arrival to Emergency Dept.
Key exclusion criteria (5 listed)
- minors
- prisoners
- non-Medtronic AICD
- unable to provide consent
- no telephone for 30 day follow up call
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
To determine if there are better methods of making the device diagnostic information accessible to ED physicians/staff
Time frame: During Emergency Department visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian C Hiestand, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congestive Heart Failure and Medical Device, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2012.