Ischemic Congestive CardiomyopathyCARE/VOLCANONCT01399801
Optimizing Left Ventricular Lead To Improve Cardiac Output
A study testing Doppler flow measurement and standard implantation of the LV lead in people with Ischemic Congestive Cardiomyopathy and Dilated Cardiomyopathy, run by Ann Marie Chikowski at 1 site in United States.
Trial summary
The purpose of this study is to determine if optimal lead placement, guided by the largest improvement in aortic flow measured by Doppler will: 1. Improve the way the heart's left ventricle functions 2. Decrease the number of hospital admissions for heart failure related symptoms 3. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ischemic Congestive Cardiomyopathy, Dilated Cardiomyopathy, Congestive Heart Failure
- What is being tested?
- Doppler flow measurement and standard implantation of the LV lead
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to 25 Sep 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical indication for CRT-P or CRT-D
- QRS Duration>=120 MSEC
- Left Ventricular Ejection fraction<=35%
- NYHA Class III-IV
- History of Cardiomyopathy, least one month post MI, or at least six months old in case of non-ischemic cardiomyopathy
- At least 18 years of afe
Who cannot join
- Previous implanted CRT-P/CRT-D
- woman who are pregnant
- Psychological or emotional problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing the Left Ventricular Contractility in Cardiac Resynchronization Therapy Using a Doppler Wire
The purpose of this study is to determine if optimal lead placement, guided by the largest improvement in aortic flow measured by Doppler will:
- Improve the way the heart's left ventricle functions
- Decrease the number of hospital admissions for heart failure related symptoms
- Reduces uncoordinated heart contractions
- Improve quality of life as measured by the Minnesota Living with Heart Failure Questionaire and NYHA Class assessed after six months
Read the detailed description
The hypothesis of this study determines if response to CRT therapy could be improved by optimizing LV lead position at the time of the left ventricular pacing lead implantation. This optimization (using a Doppler wire) would alter the left ventricular activation pattern and contraction mechanics. This increase in contractility may improve the likelihood of mid/long term response to therapy. This study will compare 6-month response to CRT (left ventricular ejection fraction, decrease in left ventricular end systolic and end diastolic dimensions and volumes) in heart failure patients.
The secondary objective will be to:
- To determine if optimal lead placement, guided by the largest improvement in stroke volume, results in a greater 6-month improvement in clinical QOL and NYHA class.
- Acutely compare and/or correlate intra-operative A-V and V-V timing optimization via invasive pressure volume data to post-operative echo optimization of these same parameters.
- Acutely contrast changes in stroke volume during pacing from several different left ventricular lead locations.
- Being tested
- Doppler flow measurement, standard implantation of the LV lead
- Keywords
- Cardiac Resynchronization Therapy, medically refractory heart failure patients
- Medical subject headings
- Cardiomyopathy, Dilated, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler flow measurementProcedure or surgery
use of doppler wire to measure change in flow that corresponds to changes in stroke volume to guide LV lead placement
standard implantation of the LV leadProcedure or surgery
Standard implantation of the LV lead with measurements of flow
| Study group | Role | What they receive |
|---|---|---|
| hemodynamicaly guided LV lead placement | Experimental | optimized left ventricular lead placement Receives: Procedure: Doppler flow measurement |
| Standard lead placement | Active comparator | Standard LV lead placement with no measurements to guide LV lead placement Receives: Procedure: standard implantation of the LV lead |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Left Ventricular End Systolic Volume (LVESV) using the difference from baseline to six months
Comparison of clinical and functional outcomes of stroke volume optimized lead placement to standard lateral lead placement.
Measured: Six months
Secondary outcomes (4)
Change in End diastolic volume
End diastolic volume should decrease over follow up time of six months as a result of left ventricular remodeling.
Measured: Six months
Change in ejection fraction
Increase in ejection fraction should happen as a result of remodeling and increased efficiency of the left ventricle
Measured: six months
Increase in exercise capacity
Inrease in exercise capacity should be result of remodeled left ventricle and increased stroke volume and cardiac output
Measured: six months
Decrease in heart failure related hospital admissions
number of hospitalizations for CHF should decrease during follow up
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startDec 2010
- Primary completion25 Sep 2014
- Study completion25 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Congestive CardiomyopathyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann Marie Chikowski
- Sponsor type
- University, hospital or other
- Collaborators
- Main Line Health
- Responsible party
- Sponsor-investigator, Ann Marie Chikowski, Main Line Health
- Investigators
- Dusan Kocovic, MD, Principal investigator, Lankenau Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01399801
- Sponsor's protocol ID
- F/N-R09-284IL
- Acronym
- CARE/VOLCANO
- Status last verified
- Aug 2022
- First submitted
- 16 Jun 2011
- Last updated
- 30 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing the Left Ventricular Contractility in Cardiac Resynchronization Therapy Using a Doppler Wire
- ClinicalTrials.gov ID
- NCT01399801
- Acronym / sponsor ID
- CARE/VOLCANO / F/N-R09-284IL
- Keywords
- Cardiac Resynchronization Therapy, medically refractory heart failure patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Ann Marie ChikowskiUniversity, hospital or other
- Collaborators
- Main Line Health
- Study start
- Dec 2010
- Primary completion
- 25 Sep 2014 (actual)
- Study completion
- 25 Sep 2014 (actual)
- First posted
- 22 Jul 2011 (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 study is to determine if optimal lead placement, guided by the largest improvement in aortic flow measured by Doppler will:
- Improve the way the heart's left ventricle functions
- Decrease the number of hospital admissions for heart failure related symptoms
- Reduces uncoordinated heart contractions
- Improve quality of life as measured by the Minnesota Living with Heart Failure Questionaire and NYHA Class assessed after six months
Detailed description
The hypothesis of this study determines if response to CRT therapy could be improved by optimizing LV lead position at the time of the left ventricular pacing lead implantation. This optimization (using a Doppler wire) would alter the left ventricular activation pattern and contraction mechanics. This increase in contractility may improve the likelihood of mid/long term response to therapy. This study will compare 6-month response to CRT (left ventricular ejection fraction, decrease in left ventricular end systolic and end diastolic dimensions and volumes) in heart failure patients.
The secondary objective will be to:
- To determine if optimal lead placement, guided by the largest improvement in stroke volume, results in a greater 6-month improvement in clinical QOL and NYHA class.
- Acutely compare and/or correlate intra-operative A-V and V-V timing optimization via invasive pressure volume data to post-operative echo optimization of these same parameters.
- Acutely contrast changes in stroke volume during pacing from several different left ventricular lead locations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hemodynamicaly guided LV lead placement | Experimental | Procedure: Doppler flow measurementoptimized left ventricular lead placement |
| Standard lead placement | Active comparator | Procedure: standard implantation of the LV leadStandard LV lead placement with no measurements to guide LV lead placement |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical indication for CRT-P or CRT-D
- QRS Duration>=120 MSEC
- Left Ventricular Ejection fraction<=35%
- NYHA Class III-IV
- History of Cardiomyopathy, least one month post MI, or at least six months old in case of non-ischemic cardiomyopathy
Key exclusion criteria (3 listed)
- Previous implanted CRT-P/CRT-D
- woman who are pregnant
- Psychological or emotional problems
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 |
|---|---|---|
| Doppler flow measurementuse of doppler wire to measure change in flow that corresponds to changes in stroke volume to guide LV lead placement | Procedure or surgery | hemodynamicaly guided LV lead placement |
| standard implantation of the LV leadStandard implantation of the LV lead with measurements of flow | Procedure or surgery | Standard lead placement |
Primary outcome
Change in Left Ventricular End Systolic Volume (LVESV) using the difference from baseline to six months
Time frame: Six months
Comparison of clinical and functional outcomes of stroke volume optimized lead placement to standard lateral lead placement.
4 secondary outcomes
Change in End diastolic volume
Time frame: Six months
Change in ejection fraction
Time frame: six months
Increase in exercise capacity
Time frame: six months
Decrease in heart failure related hospital admissions
Time frame: six months
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 30 Aug 2022.
Related trials for Ischemic Congestive Cardiomyopathy
Active, not recruitingObservational study
Prediction of ARrhythmic Events With Positron Emission Tomography II
Sudden Cardiac Arrest, Ischemic Cardiomyopathy
RecruitingObservational study
Phenotypic Classification of FMR With CMR
Nonischemic Congestive Cardiomyopathy, Functional Mitral Regurgitation
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.
Dusan Kocovic, MD principal investigator
Lankenau Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doppler flow measurement and standard implantation of the LV lead in people with Ischemic Congestive Cardiomyopathy and Dilated Cardiomyopathy, run by Ann Marie Chikowski 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 6 inclusion and 3 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 30 Aug 2022. 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?
Change in Left Ventricular End Systolic Volume (LVESV) using the difference from baseline to six months (time frame: Six months). 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 30 Aug 2022; AzTrials last refreshed its copy on 30 Oct 2026.