Effects of Mitral Valve Repair With the Geoform Ring on Cardiomyopathy
NCT ID: NCT00428103
Last Updated: 2013-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
NA
INTERVENTIONAL
2006-10-31
2012-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Prediction of Reverse Remodeling and Outcome in Patients With Severe Secondary Mitral Valve Regurgitation Undergoing Transcatheter Edge-to-edge Mitral Valve Repair
NCT04913727
Effect of RT3D-TEE-guided Mitral Valve Repair on Outcomes in Patients With Degenerative Mitral Valve Disease
NCT05595226
Left Chamber Function in Mitral Regurgitation and Predicting Outcome After Replacement and Targeting for Early Surgery
NCT03870516
Mitral Valve Area Using 3-dimensional Transesophageal Echocardiography
NCT01694251
EASE MITRAL Expertise-based Assessment Study on Clinical Efficacy of Profile 3D in MITRAL Valve Annuloplasty
NCT01112566
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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:
1. 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.
2. To evaluate the effects on mitral valve annuloplasty with a Geoform ring on functional status.
Secondary endpoints will be:
3. To evaluate the effect of mitral valve annuloplasty with a Geoform ring on mortality.
4. To evaluate its effects on hospitalization for congestive heart failure.
5. To evaluate the effect on the need of further interventions for congestive heart failure (insertion of ventricular assist device, transplantation, cardiac resynchronization therapy).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
3 dimensional echocardiography
Lab tests: BNP, 6 minute walk test Transthoracic 3D echocardiogram
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Edwards Lifesciences
INDUSTRY
University of Michigan
OTHER
Juan Crestanello, MD
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Juan Crestanello, MD
Associate Professor of Surgery
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Juan Crestanello, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Nadia Nathan, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Subha Raman, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Steven Bolling, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Min Pu, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Ohio State University
Columbus, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Romano 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.
Levi 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.
Romano MA, Bolling SF. Mitral valve repair as an alternative treatment for heart failure patients. Heart Fail Monit. 2003;4(1):7-12.
Badhwar 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.
Bolling SF. Mitral reconstruction in cardiomyopathy. J Heart Valve Dis. 2002 Jan;11 Suppl 1:S26-31.
Bolling 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.
Smolens 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.
Bolling SF. Mitral valve reconstruction in the patient with heart failure. Heart Fail Rev. 2001 Sep;6(3):177-85. doi: 10.1023/a:1011421014480.
Otsuji 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.
Verhey 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
0006378
Identifier Type: OTHER
Identifier Source: secondary_id
2006H0138
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.