Destiny Trial: Effects of Mitral Valve Annuloplasty With the Geoform Ring on Left Ventricular Geometry and Function in Patients With Cardiomyopathy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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: 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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 mm
- •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.
排除标准
- •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.
结局指标
主要结局
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.
时间窗: Post operative Mitral Valve repair
To evaluate effects on mitral valve annuloplasty with a Geoform ring on functional status.
时间窗: Postoperative Mitral Valve repair
次要结局
- To evaluate effect of mitral valve annuloplasty with a Geoform ring on mortality.(Postoperative)
- To evaluate effects on hospitalization for congestive heart failure.(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).(Postoperative Mitral Valve repair)
研究者
Juan Crestanello, MD
Associate Professor of Surgery
Ohio State University