Mitral Valve RegurgitationNCT00428103
Effects of Mitral Valve Repair With the Geoform Ring on Cardiomyopathy
A study testing 3 dimensional echocardiography in people with Mitral Valve Regurgitation and Congestive Heart Failure, run by Juan Crestanello, MD at 1 site in United States.
Trial summary
The primary aim of this study is to assess the changes on the shape and function of the left ventricle in patients with severe mitral valve regurgitation due to congestive heart failure and cardiomyopathy who undergo mitral valve reconstruction with a Geoform ring. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Regurgitation, Congestive Heart Failure, Cardiomyopathy
- What is being tested?
- 3 dimensional echocardiography
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Dec 2012
- 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 would be at least 18 years old.
- They will have history of congestive heart failure and be in New York Heart Association Class III or IV.
- Their left ventricular ejection fraction will be less or equal to 30%.
- They will have moderate or severe mitral regurgitation as determined by echocardiogram. Echocardiogram's criteria for severe mitral regurgitation will be:
- regurgitant volume greater than 50 ml,
- regurgitant fraction greater than 50% and
- effective regurgitant orifice greater than 40 mm2.
- If the quantitative criteria are not available, severity of the MR will be graded qualitative in grades I, II, III, and IV. Patients with mitral regurgitation in grade III and IV will be eligible to be included in the study.
Who cannot join
- Cancer - Metastatic or any cancer within five years except patients with non- melanoma skin cancer.
- Recent stroke (less than six months).
- Severe COPD (patients with an FEV1 less than .8 liters).
- Patients on inotropic infusion preoperatively.
- Patients in atrial fibrillation.
- Pregnant patients.
- Patients with any other valvular disease that required surgical intervention except tricuspid valve disease.
- Patients that will require surgical ventricular restoration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Destiny Trial: Effects of Mitral Valve Annuloplasty With the Geoform Ring on Left Ventricular Geometry and Function in Patients With Cardiomyopathy
The primary aim of this study is to assess the changes on the shape and function of the left ventricle in patients with severe mitral valve regurgitation due to congestive heart failure and cardiomyopathy who undergo mitral valve reconstruction with a Geoform ring. Three-dimensional echocardiogram will be used for precise evaluation of the shape and function of the ventricle.
Read the detailed description
Congestive heart failure is a leading cause of hospitalization and mortality with an estimated 5 million people affected in the United States of America. Ischemic and idiopathic (dilated) cardiomyopathies are the two most common etiologies. As the left ventricle fails, changes in ventricular geometry and function occurs that leads to functional mitral regurgitation. Mitral regurgitation is a complication of end stage cardiomyopathy that adversely affects survival and patient's functional status. Mitral regurgitation in these patients is not an intrinsic disease of the mitral valve but rather results from mitral annular dilatation and ventricular dilatation.
Geoform mitral annuloplasty ring reduces the antero-posterior diameter of the mitral valve and elevates the posterior mitral annulus. Although it has been very effective on eliminating mitral regurgitation its effects on ventricular geometry have not been fully elucidated. Evaluation of ventricular and mitral valve geometry and function and their interactions has been difficult. The availability of three dimensional echocardiogram with sophisticated finite volume analysis allows us to evaluate the changes in ventricular geometry associated with the implantation of the Geoform ring. We have then designed this study with the purpose of evaluating the changes in left ventricular geometry and function resulting from mitral valve annuloplasty with the Geoform ring in patients with left ventricular dysfunction and congestive heart failure.
The two primary endpoints of this study will be:
- To assess the changes on left ventricular geometry and function as assessed by 3D echocardiography in patients with cardiomyopathy and severe mitral regurgitation who undergo mitral valve annuloplasty with a Geoform ring. This assessment will be done preoperatively, at three months, at six months, at one year, and at two years after the procedure.
- To evaluate the effects on mitral valve annuloplasty with a Geoform ring on functional status. Secondary endpoints will be:
- To evaluate the effect of mitral valve annuloplasty with a Geoform ring on mortality.
- To evaluate its effects on hospitalization for congestive heart failure.
- To evaluate the effect on the need of further interventions for congestive heart failure (insertion of ventricular assist device, transplantation, cardiac resynchronization therapy).
- Being tested
- 3 dimensional echocardiography
- Keywords
- Mitral valve regurgitation
- Medical subject headings
- Mitral Valve Insufficiency, Heart Failure, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 dimensional echocardiographyProcedure or surgery
Lab tests: BNP, 6 minute walk test Transthoracic 3D echocardiogram
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess changes on left ventricular geometry and function using 3D echocardiography in patients with cardiomyopathy and severe mitral regurgitation who undergo mitral valve annuloplasty with a Geoform ring.
Measured: Post operative Mitral Valve repair
To evaluate effects on mitral valve annuloplasty with a Geoform ring on functional status.
Measured: Postoperative Mitral Valve repair
Secondary outcomes (3)
To evaluate effect of mitral valve annuloplasty with a Geoform ring on mortality.
Measured: Postoperative
To evaluate effects on hospitalization for congestive heart failure.
Measured: Hospital admissions that occur after intial postoperative discharge
To evaluate effect on the need of further interventions for congestive heart failure (insertion of ventricular assist device, transplantation, cardiac resynchronization therapy).
Measured: Postoperative Mitral Valve repair
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2007 (estimated)
- Study startOct 2006
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Mitral Valve RegurgitationStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juan Crestanello, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Edwards Lifesciences, University of Michigan
- Responsible party
- Sponsor-investigator, Juan Crestanello, MD, Ohio State University
- Investigators
- Juan Crestanello, MD, Principal investigator, Ohio State UniversityNadia Nathan, MD, Principal investigator, Ohio State UniversitySubha Raman, MD, Principal investigator, Ohio State UniversitySteven Bolling, MD, Principal investigator, University of MichiganMin Pu, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00428103
- Sponsor's protocol ID
- 2006H0138
- Other IDs
- 0006378
- Status last verified
- Feb 2013
- First submitted
- 25 Jan 2007
- Last updated
- 28 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Smolens IA, Bolling SF. Surgical approaches to dilated cardiomyopathy. Curr Cardiol Rep. 2000 Mar;2(2):99-105. doi: 10.1007/s11886-000-0005-6.
PubMed 10980879Romano MA, Bolling SF. Update on mitral repair in dilated cardiomyopathy. J Card Surg. 2004 Sep-Oct;19(5):396-400. doi: 10.1111/j.0886-0440.2004.04079.x.
PubMed 15383049Levi GS, Bolling SF, Bach DS. Eccentric mitral regurgitation jets among patients having sustained inferior wall myocardial infarction. Echocardiography. 2001 Feb;18(2):97-103. doi: 10.1046/j.1540-8175.2001.00097.x.
PubMed 11262532Romano MA, Bolling SF. Mitral valve repair as an alternative treatment for heart failure patients. Heart Fail Monit. 2003;4(1):7-12.
PubMed 12808479Badhwar V, Bolling SF. Mitral valve surgery in the patient with left ventricular dysfunction. Semin Thorac Cardiovasc Surg. 2002 Apr;14(2):133-6. doi: 10.1053/stcs.2002.32314.
PubMed 11988951Bolling SF. Mitral reconstruction in cardiomyopathy. J Heart Valve Dis. 2002 Jan;11 Suppl 1:S26-31.
PubMed 11843517Bolling SF, Smolens IA, Pagani FD. Surgical alternatives for heart failure. J Heart Lung Transplant. 2001 Jul;20(7):729-33. doi: 10.1016/s1053-2498(01)00239-x.
PubMed 11448798Smolens IA, Pagani FD, Bolling SF. Mitral valve repair in heart failure. Eur J Heart Fail. 2000 Dec;2(4):365-71. doi: 10.1016/s1388-9842(00)00125-2.
PubMed 11113712Bolling SF. Mitral valve reconstruction in the patient with heart failure. Heart Fail Rev. 2001 Sep;6(3):177-85. doi: 10.1023/a:1011421014480.
PubMed 11391035Otsuji Y, Handschumacher MD, Schwammenthal E, Jiang L, Song JK, Guerrero JL, Vlahakes GJ, Levine RA. Insights from three-dimensional echocardiography into the mechanism of functional mitral regurgitation: direct in vivo demonstration of altered leaflet tethering geometry. Circulation. 1997 Sep 16;96(6):1999-2008. doi: 10.1161/01.cir.96.6.1999.
PubMed 9323092Verhey JF, Nathan NS, Rienhoff O, Kikinis R, Rakebrandt F, D'Ambra MN. Finite-element-method (FEM) model generation of time-resolved 3D echocardiographic geometry data for mitral-valve volumetry. Biomed Eng Online. 2006 Mar 3;5:17. doi: 10.1186/1475-925X-5-17.
PubMed 16512925
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Destiny Trial: Effects of Mitral Valve Annuloplasty With the Geoform Ring on Left Ventricular Geometry and Function in Patients With Cardiomyopathy
- ClinicalTrials.gov ID
- NCT00428103
- Acronym / sponsor ID
- 2006H0138
- Keywords
- Mitral valve regurgitation
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Juan Crestanello, MDUniversity, hospital or other
- Collaborators
- Edwards Lifesciences, University of Michigan
- Study start
- Oct 2006
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 29 Jan 2007 (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 primary aim of this study is to assess the changes on the shape and function of the left ventricle in patients with severe mitral valve regurgitation due to congestive heart failure and cardiomyopathy who undergo mitral valve reconstruction with a Geoform ring. Three-dimensional echocardiogram will be used for precise evaluation of the shape and function of the ventricle.
Detailed description
Congestive heart failure is a leading cause of hospitalization and mortality with an estimated 5 million people affected in the United States of America. Ischemic and idiopathic (dilated) cardiomyopathies are the two most common etiologies. As the left ventricle fails, changes in ventricular geometry and function occurs that leads to functional mitral regurgitation. Mitral regurgitation is a complication of end stage cardiomyopathy that adversely affects survival and patient's functional status. Mitral regurgitation in these patients is not an intrinsic disease of the mitral valve but rather results from mitral annular dilatation and ventricular dilatation.
Geoform mitral annuloplasty ring reduces the antero-posterior diameter of the mitral valve and elevates the posterior mitral annulus. Although it has been very effective on eliminating mitral regurgitation its effects on ventricular geometry have not been fully elucidated. Evaluation of ventricular and mitral valve geometry and function and their interactions has been difficult. The availability of three dimensional echocardiogram with sophisticated finite volume analysis allows us to evaluate the changes in ventricular geometry associated with the implantation of the Geoform ring. We have then designed this study with the purpose of evaluating the changes in left ventricular geometry and function resulting from mitral valve annuloplasty with the Geoform ring in patients with left ventricular dysfunction and congestive heart failure.
The two primary endpoints of this study will be:
- To assess the changes on left ventricular geometry and function as assessed by 3D echocardiography in patients with cardiomyopathy and severe mitral regurgitation who undergo mitral valve annuloplasty with a Geoform ring. This assessment will be done preoperatively, at three months, at six months, at one year, and at two years after the procedure.
- To evaluate the effects on mitral valve annuloplasty with a Geoform ring on functional status. Secondary endpoints will be:
- To evaluate the effect of mitral valve annuloplasty with a Geoform ring on mortality.
- To evaluate its effects on hospitalization for congestive heart failure.
- To evaluate the effect on the need of further interventions for congestive heart failure (insertion of ventricular assist device, transplantation, cardiac resynchronization therapy).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients would be at least 18 years old.
- They will have history of congestive heart failure and be in New York Heart Association Class III or IV.
- Their left ventricular ejection fraction will be less or equal to 30%.
- They will have moderate or severe mitral regurgitation as determined by echocardiogram. Echocardiogram's criteria for severe mitral regurgitation will be:
- If the quantitative criteria are not available, severity of the MR will be graded qualitative in grades I, II, III, and IV. Patients with mitral regurgitation in grade III and IV will be eligible to be included in the study.
Key exclusion criteria (8 listed)
- Cancer - Metastatic or any cancer within five years except patients with non- melanoma skin cancer.
- Recent stroke (less than six months).
- Severe COPD (patients with an FEV1 less than .8 liters).
- Patients on inotropic infusion preoperatively.
- Patients in atrial fibrillation.
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 |
|---|---|---|
| 3 dimensional echocardiographyLab tests: BNP, 6 minute walk test Transthoracic 3D echocardiogram | Procedure or surgery | – |
Primary outcome
To assess changes on left ventricular geometry and function using 3D echocardiography in patients with cardiomyopathy and severe mitral regurgitation who undergo mitral valve annuloplasty with a Geoform ring.
Time frame: Post operative Mitral Valve repair
To evaluate effects on mitral valve annuloplasty with a Geoform ring on functional status.
Time frame: Postoperative Mitral Valve repair
3 secondary outcomes
To evaluate effect of mitral valve annuloplasty with a Geoform ring on mortality.
Time frame: Postoperative
To evaluate effects on hospitalization for congestive heart failure.
Time frame: Hospital admissions that occur after intial postoperative discharge
To evaluate effect on the need of further interventions for congestive heart failure (insertion of ventricular assist device, transplantation, cardiac resynchronization therapy).
Time frame: Postoperative Mitral Valve repair
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 28 Feb 2013.
- Background: PubMed 10980879Smolens IA, Bolling SF. Surgical approaches to dilated cardiomyopathy. Curr Cardiol Rep. 2000 Mar;2(2):99-105. doi: 10.1007/s11886-000-0005-6.
- Background: PubMed 15383049Romano MA, Bolling SF. Update on mitral repair in dilated cardiomyopathy. J Card Surg. 2004 Sep-Oct;19(5):396-400. doi: 10.1111/j.0886-0440.2004.04079.x.
- Background: PubMed 11262532Levi GS, Bolling SF, Bach DS. Eccentric mitral regurgitation jets among patients having sustained inferior wall myocardial infarction. Echocardiography. 2001 Feb;18(2):97-103. doi: 10.1046/j.1540-8175.2001.00097.x.
- Background: PubMed 12808479Romano MA, Bolling SF. Mitral valve repair as an alternative treatment for heart failure patients. Heart Fail Monit. 2003;4(1):7-12.
- Background: PubMed 11988951Badhwar V, Bolling SF. Mitral valve surgery in the patient with left ventricular dysfunction. Semin Thorac Cardiovasc Surg. 2002 Apr;14(2):133-6. doi: 10.1053/stcs.2002.32314.
- Background: PubMed 11843517Bolling SF. Mitral reconstruction in cardiomyopathy. J Heart Valve Dis. 2002 Jan;11 Suppl 1:S26-31.
- Background: PubMed 11448798Bolling SF, Smolens IA, Pagani FD. Surgical alternatives for heart failure. J Heart Lung Transplant. 2001 Jul;20(7):729-33. doi: 10.1016/s1053-2498(01)00239-x.
- Background: PubMed 11113712Smolens IA, Pagani FD, Bolling SF. Mitral valve repair in heart failure. Eur J Heart Fail. 2000 Dec;2(4):365-71. doi: 10.1016/s1388-9842(00)00125-2.
- Background: PubMed 11391035Bolling SF. Mitral valve reconstruction in the patient with heart failure. Heart Fail Rev. 2001 Sep;6(3):177-85. doi: 10.1023/a:1011421014480.
- Background: PubMed 9323092Otsuji Y, Handschumacher MD, Schwammenthal E, Jiang L, Song JK, Guerrero JL, Vlahakes GJ, Levine RA. Insights from three-dimensional echocardiography into the mechanism of functional mitral regurgitation: direct in vivo demonstration of altered leaflet tethering geometry. Circulation. 1997 Sep 16;96(6):1999-2008. doi: 10.1161/01.cir.96.6.1999.
- Background: PubMed 16512925Verhey JF, Nathan NS, Rienhoff O, Kikinis R, Rakebrandt F, D'Ambra MN. Finite-element-method (FEM) model generation of time-resolved 3D echocardiographic geometry data for mitral-valve volumetry. Biomed Eng Online. 2006 Mar 3;5:17. doi: 10.1186/1475-925X-5-17.
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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.
Juan Crestanello, MD principal investigator
Ohio State University
Nadia Nathan, MD principal investigator
Ohio State University
Subha Raman, 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?
A study testing 3 dimensional echocardiography in people with Mitral Valve Regurgitation and Congestive Heart Failure, run by Juan Crestanello, MD 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 8 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 28 Feb 2013. 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?
To assess changes on left ventricular geometry and function using 3D echocardiography in patients with cardiomyopathy and severe mitral regurgitation who undergo mitral valve annuloplasty with a Geoform ring. (time frame: Post operative Mitral Valve repair). 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?
On the ClinicalTrials.gov record for NCT00428103, which also lists 11 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 28 Feb 2013.