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This study is a multi-center, prospective, non-randomized, observational study. The objectives of this study are to confirm the clinical safety and efficacy of the SJM Epic valve.
This study is a multi-centered, multi-country, prospective, non-randomized, observational study, without concurrent or matched controls, conducted under a common protocol. Bayesian methods will be used for the design and analysis of this study. The Bayesian model will determine if the data for the valve configurations are poolable. Bayesian methods also provide a means of determining the appropriate stopping time for the study based on the amount of information generated. The objectives of this study are to confirm the clinical safety and efficacy of the SJM Epic Valve by establishing the following:
- adverse effect rates
- clinical status as indicated by NYHA functional classification
- hemodynamic performance
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Valvular Heart Disease
Active, not recruiting
St. Jude Medical
Published on BioPortfolio: 2014-07-23T21:43:39-0400
Valvular heart disease (VHD) is becoming more and more frequent with the aging, which has brought a heavy burden to the world. However, the prevalence and prognosis of valvular heart disea...
The prevalence of valvular heart disease is on the rise along with the aging society and the generalization of echocardiography. Furthermore, the rheumatic valvular heart disease is much m...
Patients undergoing transcatheter valvular interventions will be prospectively included into the present registry. Baseline, procedural and follow-up data will be collected and analyzed to...
The ability to quantify flow directly using through-plane phase contrast velocity mapping is a unique advantage of cardiovascular magnetic resonance and does not rely on the calculation fr...
By bioelectrical impedance spectroscopy (BIS) association of fluid status in patients with valvular heart disease and cardiovascular outcome will be assessed.
Rheumatic heart disease (RHD) is the commonest cause of valvular heart disease and a common cause of heart failure in sub-Saharan Africa (SSA). Atrial fibrillation (AF) complicates RHD, precipitates a...
Substantial interest has been directed towards stroke risk stratification in patients with atrial fibrillation (AF) but prior studies have focused on AF without significant valvular heart disease (VHD...
Stress echocardiography (SE) is a very useful method in clinical practice, since it offers important information both for patient's functional status and hemodynamic changes during stress. Therefore, ...
Patients with chronic heart failure have alteration in body composition as a reduction in fat mass, lean body mass and bone mass. However, body wasting in valvular heart disease and the impact of corr...
Cardiac manifestation of systemic rheumatological conditions, such as RHEUMATIC FEVER. Rheumatic heart disease can involve any part the heart, most often the HEART VALVES and the ENDOCARDIUM.
Disease-related laceration or tearing of tissues of the heart, including the free-wall MYOCARDIUM; HEART SEPTUM; PAPILLARY MUSCLES; CHORDAE TENDINEAE; and any of the HEART VALVES. Pathological rupture usually results from myocardial infarction (HEART RUPTURE, POST-INFARCTION).
Diseases characterized by pathological irregularities in the HEART CONDUCTION SYSTEM. They may be associated with other heart diseases and syndromes (e.g., BRUGADA SYNDROME; NEUROMUSCULAR DISEASE, HEART BLOCKS), isolated or may result from injuries. You can have a conduction disorder without having an arrhythmia, but some arrhythmias arise from conduction disorders. OMIM: 601144.
The hemodynamic and electrophysiological action of the left HEART VENTRICLE. Its measurement is an important aspect of the clinical evaluation of patients with heart disease to determine the effects of the disease on cardiac performance.
Hypertrophy and dilation of the RIGHT VENTRICLE of the heart that is caused by PULMONARY HYPERTENSION. This condition is often associated with pulmonary parenchymal or vascular diseases, such as CHRONIC OBSTRUCTIVE PULMONARY DISEASE and PULMONARY EMBOLISM.