Heart FailureNCT01576562
Implantable Cardioverter Defibrillator (ICD) Function During Ventricular Assist Device (VAD) Implantation
An observational study of Heart Failure, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The purpose of this research study is to test the function of a subjects implantable cardioverter defibrillator (ICD) function throughout the duration of their heart surgery. ICD function can be altered during some types of heart surgery such as those when a pump (ventricular assist device - VAD) is implanted. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to May 2016
- 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: Patients with wireless ICDs undergoing VAD implantation (study group) or other cardiothoracic surgery (control group) will be included.
Who may be able to join
- Patients ages 18 and older
- Have a wireless implantable cardioverter defibrillator (ICD) and are undergoing VAD implantation or other cardiothoracic surgery.
Who cannot join
- Patients who are pacemaker dependent
- children, human fetuses, neonates
- prisoners will not be included
- Pregnant women will not be included
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
The purpose of this research study is to test the function of a subjects implantable cardioverter defibrillator (ICD) function throughout the duration of their heart surgery. ICD function can be altered during some types of heart surgery such as those when a pump (ventricular assist device - VAD) is implanted. The investigators would like to study the mechanism of device and ICD malfunction.
Read the detailed description
ICD function is typically measured prior to and after surgery. For the study, the investigators will measure ICD lead function multiple times throughout the surgery as well, to determine if and when device malfunction occurs. ICD lead function is measured noninvasively through a specialized computer the same way it is checked in the clinic. In addition, the investigators will test ICD function as they usually do following surgery.
- Conditions
- Heart Failure
- Keywords
- Implantable Cardioverter Defibrillator, Ventricular Assist Device
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study Group - Control Group | VAD implantation (study group) or other cardiothoracic surgery (control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
observational study to assess potential changes that may occur in the RV ICD lead function during LVAD implantation and what mechanism may cause those changes in RV ICD lead function
Measured: RV ICD lead function will be measured throughout LVAD placement , at 1 week post LVAD placement, and 3 months post LVAD placement Description:
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2012 (estimated)
- Study startFeb 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jordana Kron, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01576562
- Sponsor's protocol ID
- HM13674
- Status last verified
- Aug 2017
- First submitted
- 10 Apr 2012
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Hu YL, Kasirajan V, Tang DG, Shah KB, Koneru JN, Grizzard JD, Ellenbogen KA, Kron J. Prospective Evaluation of Implantable Cardioverter-Defibrillator Lead Function During and After Left Ventricular Assist Device Implantation. JACC Clin Electrophysiol. 2016 Jun;2(3):343-354. doi: 10.1016/j.jacep.2016.01.008. Epub 2016 Mar 23.
PubMed 29766894
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implantable Cardioverter Defibrillator (ICD) Function During Ventricular Assist Device (VAD) Implantation
- ClinicalTrials.gov ID
- NCT01576562
- Acronym / sponsor ID
- HM13674
- Conditions
- Heart Failure
- Keywords
- Implantable Cardioverter Defibrillator, Ventricular Assist Device
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 12 Apr 2012 (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.
The purpose of this research study is to test the function of a subjects implantable cardioverter defibrillator (ICD) function throughout the duration of their heart surgery. ICD function can be altered during some types of heart surgery such as those when a pump (ventricular assist device - VAD) is implanted. The investigators would like to study the mechanism of device and ICD malfunction.
Detailed description
ICD function is typically measured prior to and after surgery. For the study, the investigators will measure ICD lead function multiple times throughout the surgery as well, to determine if and when device malfunction occurs. ICD lead function is measured noninvasively through a specialized computer the same way it is checked in the clinic. In addition, the investigators will test ICD function as they usually do following surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group - Control Group | – | –VAD implantation (study group) or other cardiothoracic surgery (control group) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with wireless ICDs undergoing VAD implantation (study group) or other cardiothoracic surgery (control group) will be included.
Key inclusion criteria (2 listed)
- Patients ages 18 and older
- Have a wireless implantable cardioverter defibrillator (ICD) and are undergoing VAD implantation or other cardiothoracic surgery.
Key exclusion criteria (4 listed)
- Patients who are pacemaker dependent
- children, human fetuses, neonates
- prisoners will not be included
- Pregnant women will not be included
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
observational study to assess potential changes that may occur in the RV ICD lead function during LVAD implantation and what mechanism may cause those changes in RV ICD lead function
Time frame: RV ICD lead function will be measured throughout LVAD placement , at 1 week post LVAD placement, and 3 months post LVAD placement Description:
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 8 Aug 2017.
- Derived from this study: PubMed 29766894Hu YL, Kasirajan V, Tang DG, Shah KB, Koneru JN, Grizzard JD, Ellenbogen KA, Kron J. Prospective Evaluation of Implantable Cardioverter-Defibrillator Lead Function During and After Left Ventricular Assist Device Implantation. JACC Clin Electrophysiol. 2016 Jun;2(3):343-354. doi: 10.1016/j.jacep.2016.01.008. Epub 2016 Mar 23.
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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.
Jordana Kron, MD principal investigator
Virginia Commonwealth 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 Heart Failure, run by Virginia Commonwealth 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 4 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 8 Aug 2017. 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?
observational study to assess potential changes that may occur in the RV ICD lead function during LVAD implantation and what mechanism may cause those changes in RV ICD lead function (time frame: RV ICD lead function will be measured throughout LVAD placement , at 1 week post LVAD placement, and 3 months post LVAD placement Description:). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01576562, which also lists 1 linked publication.
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 8 Aug 2017.