Ischemic CardiomyopathyRAISE-CRTNCT01603706
Radial Strain ECHO-Guided Implantation of Cardiac Resynchronization Therapy
A study testing Echo guided implantation group in people with Ischemic Cardiomyopathy, run by Sheba Medical Center at 9 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the use of radial strain imaging using speckle tracking analysis to predict the response to CRT in patients with ischemic cardiomyopathy (ICMP) with NYHA functional class 2-4 heart failure and a standard guideline-based CRT indication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Cardiomyopathy
- What is being tested?
- Echo guided implantation group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 9 sitesin 2 countries
- Study dates
- May 2012to Oct 2017
- 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
- Patients with ischemic CMP based on evidence of prior MI by history, coronary angiography/revascularization or imaging
- AHA ACC or ESC EHRA Guideline-based indication (Class I or II) for CRT and NYHA class II-IV heart failure
- ECG wide QRS and :
- QRS > 120 msec in NYHA III- IV
- OR
- CLBBB or QRS > 150 in NYHA =II
Show all 9Show fewer
- Sinus rhythm predominant rhythm (PAF not an exclusion)
- All must be candidates for De novo CRT-D implantation with LV lead via transvenous approach or patients previously implanted with pacemaker or ICD with <20% pacing over the last three months who are undergoing CRT-D upgrade.
- Patient provides informed consent, tolerate a pectoral implant, agree to comply with the protocol, and maintain scheduled follow-up visits.
Who cannot join
- Permanent or persistent atrial fibrillation
- Advanced renal disease (Cr >=2.5 mg/dL)
- Advanced comorbidities with life expectancy of <1 year
- Patients on waiting list for heart transplantation
- Requiring intravenous amines (continuous or or intermittent amine drip therapy)
- Severe chronic pulmonary disease (simulating heart failure)
Show all 14Show fewer
- Severe (untreated) organic mitral valve disease
- Poorly treated hypertension
- History of myocardial infarction < 3 months; unstable angina < 1m, CABG <3 months; PCI <3 months
- Mechanical TC valve
- Previously implanted CRT system
- Poorly visualized cardiac chamber dimensions in an echocardiogram performed prior to enrollment - please help us define
- Pregnancy or child-bearing potential in the absence of accepted forms of birth control
- Concurrent enrollment in other study
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Israel8 sites
Barzilai Medical Center
Ashkelon
Carmel Medical Center
Haifa
Rambam Medical Center
Haifa
Shaare Zedek
Jerusalem
Rabin Medical Center
Petah Tikva
Sheba Medical Center
Ramat Gan
Kaplan Medical Center
Rehovot
Sorasky Medical Center
Tel Aviv
About this study
Official title: Radial Strain Imaging-Guided Lead Placement for Improving Response to Cardiac Resynchronization Therapy in Patients With Ischemic Cardiomyopathy: A Randomized Clinical Trial
The purpose of this study is to evaluate the use of radial strain imaging using speckle tracking analysis to predict the response to CRT in patients with ischemic cardiomyopathy (ICMP) with NYHA functional class 2-4 heart failure and a standard guideline-based CRT indication. Thus assessing the value of lead localization determined by radial strain imaging in a prospective, randomized manner.
Read the detailed description
In this study we propose to evaluate the utility of radial strain imaging using speckle tracking to predict the response to CRT in patients with ischemic cardiomyopathy (ICMP) with NYHA functional class 2-4 heart failure and a standard guideline-based CRT indication, and to determine the value of lead localization determined by radial strain imaging in a prospective, randomized manner. We will compare two randomized groups of CRT recipients implanted with CRT-D systems. In the control group, implantation will be performed in the usual manner and the lead will be placed at the discretion of the implanting physician, preferably at posterolateral LV sites . In the study group, leads will be placed in areas of latest contraction that lack significant scar, as determined by speckle tracking imaging. The primary outcome measure for comparison between the 2 groups will be echocardiographic response (as assessed by percent reduction in left ventricular end systolic volumes) at 6 months post-implantation. In addition, clinical response parameters will also be measured as secondary end points.
We hypothesize that 1) patients showing greater dyssynchrony and/or discoordination index with speckle tracking will derive a significantly greater response to cardiac resynchronization therapy; and 2) patients allocated to the image-guided LV lead placement group will derive a significantly greater response to CRT than patients in the non- guided implantation (control) group.
If radial strain imaging proves useful for improving the CRT response rate and identification of patients likely to respond, it will have important clinical and economic implications by improving individual outcomes and more effective utilization of constrained health care resources. Furthermore, if echo-guided lead implantation proves to be effective in reducing the relatively large non-response rate to cardiac resynchronization therapy, it will likely result in increased device utilization among eligible heart failure patients.
Specific Aims Aim #1: To show that in patients with ischemic cardiomyopathy, implantation of a CRT LV lead guided by radial strain imaging results in a significantly greater echocardiographic and clinical response to cardiac resynchronization therapy compared with conventional implantation techniques.
Aim #2: To show that speckle tracking strain data can be used to identify the degree of echocardiographic response to CRT, using both dyssynchrony (time to peak strain ) and discoordination indices.
Aim #3:
The Paieon substudy will comprise 40 patients enrolled at 3 centers, for whom additional information mechanical dyssynchrony, using the Paieon CardioGuide motion map, will be collected during device implantation as detailed below The primary aim of the study is to relate data of mechanical dyssynchrony obtained from angiography through the Paieon CardioGuide motion map to dyssynchrony data obtained from the echocardiogram.
The dyssynchrony data will not be available to the treating physicians and will not be used to direct the LV lead location.
- Conditions
- Ischemic Cardiomyopathy
- Being tested
- Echo guided implantation group
- Keywords
- Heart failure, Cardiac Resynchronization Therapy, CRT, Radial strain echocardiography, Ischemic cardiomyopathy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echo guided implantation groupProcedure or surgery
Lead placement according echo strain imaging result
| Study group | Role | What they receive |
|---|---|---|
| Echo guided implantation group | Active comparator | Echo guided implantation group Patients undergoing speckle tracking based LV lead implantation. Receives: Procedure: Echo guided implantation group |
| Conventional implantation group | No intervention | Patients undergoing conventional LV lead implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrating Percent reduction in left ventricular end systolic (LVESV) at 6 months compared with baseline values.
To show that in patients with ischemic cardiomyopathy, implantation of a CRT LV lead guided by radial strain imaging results in a significantly greater echocardiographic and clinical response to cardiac resynchronization therapy compared with conventional implantation techniques.
Measured: within 12 month from enrollment.
Secondary outcomes (3)
Clinical Improvement
A combined clinical event rate - change in NYHA, hospitalization for heart failure, death
Measured: Within 12 month from enrollment
Echocardiographic improvement
>15% improvement in LVESV, >10% improvement in LVEDV, 5% absolute improvement of LVEF
Measured: Within 12 month from enrollment
Improvement in wellbeing
10 point improvement in Minnesota Living with Heart Failure Questionnaire (MLWHF), 10% improvement of 6 minute walk test(6MWT)
Measured: Within 12 month from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2012 (estimated)
- Study startMay 2012
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Ischemic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Tel-Aviv Sourasky Medical Center, Rabin Medical Center, Rambam Health Care Campus, Kaplan Medical Center, Soroka University Medical Center, Mayo Clinic
- Responsible party
- Principal investigator, Prof. Michael Glikson, Sheba Medical Center
- Investigators
- Ilan Goldenberg, Prof., Study director, The Israeli Society for the Prevention of Heart AttacksMichael Glikson, Prof., Principal investigator, Sheba Medical CenterPaul Friedman, Prof., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01603706
- Sponsor's protocol ID
- SHEBA-12-9349-MG-CTIL
- Acronym
- RAISE-CRT
- Status last verified
- Oct 2017
- First submitted
- 14 May 2012
- Last updated
- 19 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Yu CM, Sanderson JE, Gorcsan J 3rd. Echocardiography, dyssynchrony, and the response to cardiac resynchronization therapy. Eur Heart J. 2010 Oct;31(19):2326-37. doi: 10.1093/eurheartj/ehq263. Epub 2010 Aug 13.
PubMed 20709721Miyazaki C, Redfield MM, Powell BD, Lin GM, Herges RM, Hodge DO, Olson LJ, Hayes DL, Espinosa RE, Rea RF, Bruce CJ, Nelson SM, Miller FA, Oh JK. Dyssynchrony indices to predict response to cardiac resynchronization therapy: a comprehensive prospective single-center study. Circ Heart Fail. 2010 Sep;3(5):565-73. doi: 10.1161/CIRCHEARTFAILURE.108.848085. Epub 2010 Jul 20.
PubMed 20647479Chung ES, Leon AR, Tavazzi L, Sun JP, Nihoyannopoulos P, Merlino J, Abraham WT, Ghio S, Leclercq C, Bax JJ, Yu CM, Gorcsan J 3rd, St John Sutton M, De Sutter J, Murillo J. Results of the Predictors of Response to CRT (PROSPECT) trial. Circulation. 2008 May 20;117(20):2608-16. doi: 10.1161/CIRCULATIONAHA.107.743120. Epub 2008 May 5.
PubMed 18458170Delgado V, van Bommel RJ, Bertini M, Borleffs CJ, Marsan NA, Arnold CT, Nucifora G, van de Veire NR, Ypenburg C, Boersma E, Holman ER, Schalij MJ, Bax JJ. Relative merits of left ventricular dyssynchrony, left ventricular lead position, and myocardial scar to predict long-term survival of ischemic heart failure patients undergoing cardiac resynchronization therapy. Circulation. 2011 Jan 4;123(1):70-8. doi: 10.1161/CIRCULATIONAHA.110.945345. Epub 2010 Dec 20.
PubMed 21173353Becker M, Hoffmann R, Kuhl HP, Grawe H, Katoh M, Kramann R, Bucker A, Hanrath P, Heussen N. Analysis of myocardial deformation based on ultrasonic pixel tracking to determine transmurality in chronic myocardial infarction. Eur Heart J. 2006 Nov;27(21):2560-6. doi: 10.1093/eurheartj/ehl288. Epub 2006 Oct 11.
PubMed 17035253Delgado V, Ypenburg C, van Bommel RJ, Tops LF, Mollema SA, Marsan NA, Bleeker GB, Schalij MJ, Bax JJ. Assessment of left ventricular dyssynchrony by speckle tracking strain imaging comparison between longitudinal, circumferential, and radial strain in cardiac resynchronization therapy. J Am Coll Cardiol. 2008 May 20;51(20):1944-52. doi: 10.1016/j.jacc.2008.02.040.
PubMed 18482662Tanaka H, Nesser HJ, Buck T, Oyenuga O, Janosi RA, Winter S, Saba S, Gorcsan J 3rd. Dyssynchrony by speckle-tracking echocardiography and response to cardiac resynchronization therapy: results of the Speckle Tracking and Resynchronization (STAR) study. Eur Heart J. 2010 Jul;31(14):1690-700. doi: 10.1093/eurheartj/ehq213. Epub 2010 Jun 8.
PubMed 20530502Kirn B, Jansen A, Bracke F, van Gelder B, Arts T, Prinzen FW. Mechanical discoordination rather than dyssynchrony predicts reverse remodeling upon cardiac resynchronization. Am J Physiol Heart Circ Physiol. 2008 Aug;295(2):H640-6. doi: 10.1152/ajpheart.00106.2008. Epub 2008 May 30.
PubMed 18515652Wang CL, Wu CT, Yeh YH, Wu LS, Chang CJ, Ho WJ, Hsu LA, Luqman N, Kuo CT. Recoordination rather than resynchronization predicts reverse remodeling after cardiac resynchronization therapy. J Am Soc Echocardiogr. 2010 Jun;23(6):611-20. doi: 10.1016/j.echo.2010.03.012. Epub 2010 Apr 24.
PubMed 20418055Wang CL, Powell BD, Redfield MM, Miyazaki C, Fine NM, Olson LJ, Cha YM, Espinosa RE, Hayes DL, Hodge DO, Lin G, Friedman PA, Oh JK. Left ventricular discoordination index measured by speckle tracking strain rate imaging predicts reverse remodelling and survival after cardiac resynchronization therapy. Eur J Heart Fail. 2012 May;14(5):517-25. doi: 10.1093/eurjhf/hfs025. Epub 2012 Mar 12.
PubMed 22411692Sung RK, Foster E. Assessment of systolic dyssynchrony for cardiac resynchronization therapy is not clinically useful. Circulation. 2011 Feb 15;123(6):656-62. doi: 10.1161/CIRCULATIONAHA.110.954420. No abstract available.
PubMed 21321181Kindermann M, Frohlig G, Doerr T, Schieffer H. Optimizing the AV delay in DDD pacemaker patients with high degree AV block: mitral valve Doppler versus impedance cardiography. Pacing Clin Electrophysiol. 1997 Oct;20(10 Pt 1):2453-62. doi: 10.1111/j.1540-8159.1997.tb06085.x.
PubMed 9358487
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radial Strain Imaging-Guided Lead Placement for Improving Response to Cardiac Resynchronization Therapy in Patients With Ischemic Cardiomyopathy: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01603706
- Acronym / sponsor ID
- RAISE-CRT / SHEBA-12-9349-MG-CTIL
- Conditions
- Ischemic Cardiomyopathy
- Keywords
- Heart failure, Cardiac Resynchronization Therapy, CRT, Radial strain echocardiography, Ischemic cardiomyopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Tel-Aviv Sourasky Medical Center, Rabin Medical Center, Rambam Health Care Campus, Kaplan Medical Center, Soroka University Medical Center, Mayo Clinic
- Study start
- May 2012
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 22 May 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 study is to evaluate the use of radial strain imaging using speckle tracking analysis to predict the response to CRT in patients with ischemic cardiomyopathy (ICMP) with NYHA functional class 2-4 heart failure and a standard guideline-based CRT indication. Thus assessing the value of lead localization determined by radial strain imaging in a prospective, randomized manner.
Detailed description
In this study we propose to evaluate the utility of radial strain imaging using speckle tracking to predict the response to CRT in patients with ischemic cardiomyopathy (ICMP) with NYHA functional class 2-4 heart failure and a standard guideline-based CRT indication, and to determine the value of lead localization determined by radial strain imaging in a prospective, randomized manner. We will compare two randomized groups of CRT recipients implanted with CRT-D systems. In the control group, implantation will be performed in the usual manner and the lead will be placed at the discretion of the implanting physician, preferably at posterolateral LV sites . In the study group, leads will be placed in areas of latest contraction that lack significant scar, as determined by speckle tracking imaging. The primary outcome measure for comparison between the 2 groups will be echocardiographic response (as assessed by percent reduction in left ventricular end systolic volumes) at 6 months post-implantation. In addition, clinical response parameters will also be measured as secondary end points.
We hypothesize that 1) patients showing greater dyssynchrony and/or discoordination index with speckle tracking will derive a significantly greater response to cardiac resynchronization therapy; and 2) patients allocated to the image-guided LV lead placement group will derive a significantly greater response to CRT than patients in the non- guided implantation (control) group.
If radial strain imaging proves useful for improving the CRT response rate and identification of patients likely to respond, it will have important clinical and economic implications by improving individual outcomes and more effective utilization of constrained health care resources. Furthermore, if echo-guided lead implantation proves to be effective in reducing the relatively large non-response rate to cardiac resynchronization therapy, it will likely result in increased device utilization among eligible heart failure patients.
Specific Aims Aim #1: To show that in patients with ischemic cardiomyopathy, implantation of a CRT LV lead guided by radial strain imaging results in a significantly greater echocardiographic and clinical response to cardiac resynchronization therapy compared with conventional implantation techniques.
Aim #2: To show that speckle tracking strain data can be used to identify the degree of echocardiographic response to CRT, using both dyssynchrony (time to peak strain ) and discoordination indices.
Aim #3:
The Paieon substudy will comprise 40 patients enrolled at 3 centers, for whom additional information mechanical dyssynchrony, using the Paieon CardioGuide motion map, will be collected during device implantation as detailed below The primary aim of the study is to relate data of mechanical dyssynchrony obtained from angiography through the Paieon CardioGuide motion map to dyssynchrony data obtained from the echocardiogram.
The dyssynchrony data will not be available to the treating physicians and will not be used to direct the LV lead location.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Echo guided implantation group | Active comparator | Procedure: Echo guided implantation groupEcho guided implantation group Patients undergoing speckle tracking based LV lead implantation. |
| Conventional implantation group | No intervention | –Patients undergoing conventional LV lead implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with ischemic CMP based on evidence of prior MI by history, coronary angiography/revascularization or imaging
- AHA ACC or ESC EHRA Guideline-based indication (Class I or II) for CRT and NYHA class II-IV heart failure
- ECG wide QRS and :
- QRS > 120 msec in NYHA III- IV
- OR
Key exclusion criteria (14 listed)
- Permanent or persistent atrial fibrillation
- Advanced renal disease (Cr >=2.5 mg/dL)
- Advanced comorbidities with life expectancy of <1 year
- Patients on waiting list for heart transplantation
- Requiring intravenous amines (continuous or or intermittent amine drip therapy)
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 |
|---|---|---|
| Echo guided implantation groupLead placement according echo strain imaging result | Procedure or surgery | Echo guided implantation group |
Primary outcome
Demonstrating Percent reduction in left ventricular end systolic (LVESV) at 6 months compared with baseline values.
Time frame: within 12 month from enrollment.
To show that in patients with ischemic cardiomyopathy, implantation of a CRT LV lead guided by radial strain imaging results in a significantly greater echocardiographic and clinical response to cardiac resynchronization therapy compared with conventional implantation techniques.
3 secondary outcomes
Clinical Improvement
Time frame: Within 12 month from enrollment
Echocardiographic improvement
Time frame: Within 12 month from enrollment
Improvement in wellbeing
Time frame: Within 12 month from enrollment
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 19 Oct 2017.
- Background: PubMed 20709721Yu CM, Sanderson JE, Gorcsan J 3rd. Echocardiography, dyssynchrony, and the response to cardiac resynchronization therapy. Eur Heart J. 2010 Oct;31(19):2326-37. doi: 10.1093/eurheartj/ehq263. Epub 2010 Aug 13.
- Background: PubMed 20647479Miyazaki C, Redfield MM, Powell BD, Lin GM, Herges RM, Hodge DO, Olson LJ, Hayes DL, Espinosa RE, Rea RF, Bruce CJ, Nelson SM, Miller FA, Oh JK. Dyssynchrony indices to predict response to cardiac resynchronization therapy: a comprehensive prospective single-center study. Circ Heart Fail. 2010 Sep;3(5):565-73. doi: 10.1161/CIRCHEARTFAILURE.108.848085. Epub 2010 Jul 20.
- Background: PubMed 18458170Chung ES, Leon AR, Tavazzi L, Sun JP, Nihoyannopoulos P, Merlino J, Abraham WT, Ghio S, Leclercq C, Bax JJ, Yu CM, Gorcsan J 3rd, St John Sutton M, De Sutter J, Murillo J. Results of the Predictors of Response to CRT (PROSPECT) trial. Circulation. 2008 May 20;117(20):2608-16. doi: 10.1161/CIRCULATIONAHA.107.743120. Epub 2008 May 5.
- Background: PubMed 21173353Delgado V, van Bommel RJ, Bertini M, Borleffs CJ, Marsan NA, Arnold CT, Nucifora G, van de Veire NR, Ypenburg C, Boersma E, Holman ER, Schalij MJ, Bax JJ. Relative merits of left ventricular dyssynchrony, left ventricular lead position, and myocardial scar to predict long-term survival of ischemic heart failure patients undergoing cardiac resynchronization therapy. Circulation. 2011 Jan 4;123(1):70-8. doi: 10.1161/CIRCULATIONAHA.110.945345. Epub 2010 Dec 20.
- Background: PubMed 17035253Becker M, Hoffmann R, Kuhl HP, Grawe H, Katoh M, Kramann R, Bucker A, Hanrath P, Heussen N. Analysis of myocardial deformation based on ultrasonic pixel tracking to determine transmurality in chronic myocardial infarction. Eur Heart J. 2006 Nov;27(21):2560-6. doi: 10.1093/eurheartj/ehl288. Epub 2006 Oct 11.
- Background: PubMed 18482662Delgado V, Ypenburg C, van Bommel RJ, Tops LF, Mollema SA, Marsan NA, Bleeker GB, Schalij MJ, Bax JJ. Assessment of left ventricular dyssynchrony by speckle tracking strain imaging comparison between longitudinal, circumferential, and radial strain in cardiac resynchronization therapy. J Am Coll Cardiol. 2008 May 20;51(20):1944-52. doi: 10.1016/j.jacc.2008.02.040.
- Background: PubMed 20530502Tanaka H, Nesser HJ, Buck T, Oyenuga O, Janosi RA, Winter S, Saba S, Gorcsan J 3rd. Dyssynchrony by speckle-tracking echocardiography and response to cardiac resynchronization therapy: results of the Speckle Tracking and Resynchronization (STAR) study. Eur Heart J. 2010 Jul;31(14):1690-700. doi: 10.1093/eurheartj/ehq213. Epub 2010 Jun 8.
- Background: PubMed 18515652Kirn B, Jansen A, Bracke F, van Gelder B, Arts T, Prinzen FW. Mechanical discoordination rather than dyssynchrony predicts reverse remodeling upon cardiac resynchronization. Am J Physiol Heart Circ Physiol. 2008 Aug;295(2):H640-6. doi: 10.1152/ajpheart.00106.2008. Epub 2008 May 30.
- Background: PubMed 20418055Wang CL, Wu CT, Yeh YH, Wu LS, Chang CJ, Ho WJ, Hsu LA, Luqman N, Kuo CT. Recoordination rather than resynchronization predicts reverse remodeling after cardiac resynchronization therapy. J Am Soc Echocardiogr. 2010 Jun;23(6):611-20. doi: 10.1016/j.echo.2010.03.012. Epub 2010 Apr 24.
- Background: PubMed 22411692Wang CL, Powell BD, Redfield MM, Miyazaki C, Fine NM, Olson LJ, Cha YM, Espinosa RE, Hayes DL, Hodge DO, Lin G, Friedman PA, Oh JK. Left ventricular discoordination index measured by speckle tracking strain rate imaging predicts reverse remodelling and survival after cardiac resynchronization therapy. Eur J Heart Fail. 2012 May;14(5):517-25. doi: 10.1093/eurjhf/hfs025. Epub 2012 Mar 12.
- Background: PubMed 21321181Sung RK, Foster E. Assessment of systolic dyssynchrony for cardiac resynchronization therapy is not clinically useful. Circulation. 2011 Feb 15;123(6):656-62. doi: 10.1161/CIRCULATIONAHA.110.954420. No abstract available.
- Background: PubMed 9358487Kindermann M, Frohlig G, Doerr T, Schieffer H. Optimizing the AV delay in DDD pacemaker patients with high degree AV block: mitral valve Doppler versus impedance cardiography. Pacing Clin Electrophysiol. 1997 Oct;20(10 Pt 1):2453-62. doi: 10.1111/j.1540-8159.1997.tb06085.x.
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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.
Ilan Goldenberg, Prof. study director
The Israeli Society for the Prevention of Heart Attacks
Michael Glikson, Prof. principal investigator
Sheba Medical Center
Paul Friedman, Prof. principal investigator
Mayo Clinic
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Echo guided implantation group in people with Ischemic Cardiomyopathy, run by Sheba Medical Center at 9 sites in 2 countries.
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 9 inclusion and 14 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 19 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Israel, 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?
Demonstrating Percent reduction in left ventricular end systolic (LVESV) at 6 months compared with baseline values. (time frame: within 12 month from 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 NCT01603706, which also lists 12 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 19 Oct 2017.