CardiomyopathyNCT01825239
Virtual LV Lead Navigation in Patients With Ischemic Cardiomyopathy
A study testing Collection of measurements during LV pacing during electrophysiology study in people with Cardiomyopathy and Ischemic Cardiomyopathy, run by University of Pittsburgh at 1 site in United States.
Trial summary
Presently, the left ventricular lead is placed in a similar position for all patients. It is not known whether placing this lead in different positions in the heart will make the heart pump better. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiomyopathy, Ischemic Cardiomyopathy
- What is being tested?
- Collection of measurements during LV pacing during electrophysiology study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Oct 2014
- Phase
- Interventional
- 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
Who may be able to join
- Ischemic cardiomyopathy
- Intrinsic QRS duration >120 milliseconds
- LV ejection fraction <40%
Who cannot join
- Persistent atrial tachyarrhythmia
- Active cardiac ischemia
- Cerebrovascular accident within 6 months
- Surgical or percutaneous cardiac revascularization procedure within 3 months
- Under 18 years of age
- Pregnant
- Participating in a clinical study that would preclude enrollment
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Virtual Left Ventricular Lead Navigation in Patients With Ischemic Cardiomyopathy
Presently, the left ventricular lead is placed in a similar position for all patients. It is not known whether placing this lead in different positions in the heart will make the heart pump better. In this study, the investigator will collect measurements of the heart's electrical activity during an Electrophysiology Study (EP study or EPS). The hope is that these measurements will provide the know how to develop an individualized left ventricular lead placement "prescription" for patients referred for left ventricular lead pacing.
- Conditions
- Cardiomyopathy, Ischemic Cardiomyopathy
- Being tested
- Collection of measurements during LV pacing during electrophysiology study
- Keywords
- ischemic cardiomyopathy, cardiomyopathy, left ventricular lead, cardiac electrophysiologic studies
- Medical subject headings
- Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of measurements during LV pacing during electrophysiology studyOther
During the electrophysiology study, measurements will be obtained while pacing from different left ventricular regions in context to scar as determined by SPECT-CT testing.
| Study group | Role | What they receive |
|---|---|---|
| Electrophysiology Study | Other | This is a single arm study, all study participants will be referred for an Electrophysiology Study Receives: Other: Collection of measurements during LV pacing during electrophysiology study |
What is being measured
The primary outcome is the main question the study is designed to answer.
dP/dt measurements observed during pacing from different left ventricular regions
During the electrophysiology study, the dP/dt measurements will be observed during pacing from different left ventricular regions.
Measured: Measurements will be observed at the time of the electrophysiology study (EPS) at enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study startApr 2014
- Primary completionOct 2014
- Study completionOct 2014
Why it stopped: Problems with execution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for CardiomyopathyStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, David Schwartzman, University of Pittsburgh
- Investigators
- David S. Schwartzman, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01825239
- Sponsor's protocol ID
- PRO12070339
- Status last verified
- Aug 2015
- First submitted
- 2 Apr 2013
- Last updated
- 7 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hayes, D.L, et al. Resynchronization and Defibrillation for Heart Failure: A Practical Approach. UK: Blackwell Publishing, 2004.
Ellenbogen K.A., et al. Device Therapy for Congestive Heart Failure. Pennsylvania: Saunders, 2004.
Szydlo K, Wita K, Trusz-Gluza M, Urbanczyk D, Filipecki A, Orszulak W, Tabor Z, Krauze J, Kwasniewski W, Myszor J, Turski M, Kolasa J, Szczogiel J. Impact of left ventricular remodeling on ventricular repolarization and heart rate variability in patients after myocardial infarction treated with primary PCI: prospective 6 months follow-up. Ann Noninvasive Electrocardiol. 2008 Jan;13(1):8-13. doi: 10.1111/j.1542-474X.2007.00195.x.
PubMed 18234001Cohn JN, Ferrari R, Sharpe N. Cardiac remodeling--concepts and clinical implications: a consensus paper from an international forum on cardiac remodeling. Behalf of an International Forum on Cardiac Remodeling. J Am Coll Cardiol. 2000 Mar 1;35(3):569-82. doi: 10.1016/s0735-1097(99)00630-0.
PubMed 10716457S. Goel. Pacing For Patients With Congestive Heart Failure and Dilated Cardiomyopathy www.dcmsonline.org February, 2002/ Jacksonville Medicine
Adelstein EC, Saba S. Scar burden by myocardial perfusion imaging predicts echocardiographic response to cardiac resynchronization therapy in ischemic cardiomyopathy. Am Heart J. 2007 Jan;153(1):105-12. doi: 10.1016/j.ahj.2006.10.015.
PubMed 17174647Barold SS, Herwerg B. Pacing in heart failure: how many leads and where? Heart. 2008 Jan;94(1):10-2. doi: 10.1136/hrt.2007.119404. No abstract available.
PubMed 18083947Schwartzman D, et al. Image-guided left ventricular pacing. Europace 2010; 12: 877-81.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Left Ventricular Lead Navigation in Patients With Ischemic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT01825239
- Acronym / sponsor ID
- PRO12070339
- Conditions
- Cardiomyopathy, Ischemic Cardiomyopathy
- Keywords
- ischemic cardiomyopathy, cardiomyopathy, left ventricular lead, cardiac electrophysiologic studies
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Problems with execution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Apr 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 5 Apr 2013 (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.
Presently, the left ventricular lead is placed in a similar position for all patients. It is not known whether placing this lead in different positions in the heart will make the heart pump better. In this study, the investigator will collect measurements of the heart's electrical activity during an Electrophysiology Study (EP study or EPS). The hope is that these measurements will provide the know how to develop an individualized left ventricular lead placement "prescription" for patients referred for left ventricular lead pacing.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electrophysiology Study | Other | Other: Collection of measurements during LV pacing during electrophysiology studyThis is a single arm study, all study participants will be referred for an Electrophysiology Study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ischemic cardiomyopathy
- Intrinsic QRS duration >120 milliseconds
- LV ejection fraction <40%
Key exclusion criteria (8 listed)
- Persistent atrial tachyarrhythmia
- Active cardiac ischemia
- Cerebrovascular accident within 6 months
- Surgical or percutaneous cardiac revascularization procedure within 3 months
- Under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of measurements during LV pacing during electrophysiology studyDuring the electrophysiology study, measurements will be obtained while pacing from different left ventricular regions in context to scar as determined by SPECT-CT testing. | Other | Electrophysiology Study |
Primary outcome
dP/dt measurements observed during pacing from different left ventricular regions
Time frame: Measurements will be observed at the time of the electrophysiology study (EPS) at enrollment.
During the electrophysiology study, the dP/dt measurements will be observed during pacing from different left ventricular regions.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2015.
- BackgroundHayes, D.L, et al. Resynchronization and Defibrillation for Heart Failure: A Practical Approach. UK: Blackwell Publishing, 2004.
- BackgroundEllenbogen K.A., et al. Device Therapy for Congestive Heart Failure. Pennsylvania: Saunders, 2004.
- Background: PubMed 18234001Szydlo K, Wita K, Trusz-Gluza M, Urbanczyk D, Filipecki A, Orszulak W, Tabor Z, Krauze J, Kwasniewski W, Myszor J, Turski M, Kolasa J, Szczogiel J. Impact of left ventricular remodeling on ventricular repolarization and heart rate variability in patients after myocardial infarction treated with primary PCI: prospective 6 months follow-up. Ann Noninvasive Electrocardiol. 2008 Jan;13(1):8-13. doi: 10.1111/j.1542-474X.2007.00195.x.
- Background: PubMed 10716457Cohn JN, Ferrari R, Sharpe N. Cardiac remodeling--concepts and clinical implications: a consensus paper from an international forum on cardiac remodeling. Behalf of an International Forum on Cardiac Remodeling. J Am Coll Cardiol. 2000 Mar 1;35(3):569-82. doi: 10.1016/s0735-1097(99)00630-0.
- BackgroundS. Goel. Pacing For Patients With Congestive Heart Failure and Dilated Cardiomyopathy www.dcmsonline.org February, 2002/ Jacksonville Medicine
- Background: PubMed 17174647Adelstein EC, Saba S. Scar burden by myocardial perfusion imaging predicts echocardiographic response to cardiac resynchronization therapy in ischemic cardiomyopathy. Am Heart J. 2007 Jan;153(1):105-12. doi: 10.1016/j.ahj.2006.10.015.
- Background: PubMed 18083947Barold SS, Herwerg B. Pacing in heart failure: how many leads and where? Heart. 2008 Jan;94(1):10-2. doi: 10.1136/hrt.2007.119404. No abstract available.
- BackgroundSchwartzman D, et al. Image-guided left ventricular pacing. Europace 2010; 12: 877-81.
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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.
David S. Schwartzman, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collection of measurements during LV pacing during electrophysiology study in people with Cardiomyopathy and Ischemic Cardiomyopathy, run by University of Pittsburgh 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 3 inclusion and 8 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: withdrawn, as of the sponsor's last update on 7 Aug 2015. 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 was withdrawn before enrolling participants, so there are no results.
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?
dP/dt measurements observed during pacing from different left ventricular regions (time frame: Measurements will be observed at the time of the electrophysiology study (EPS) at enrollment.). 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 NCT01825239, which also lists 8 linked publications.
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 7 Aug 2015.