Clinical Trials

Patients with aortic stenosis, hypertrophic cardiomyopathy, mitral regurgitation, aortic regurgitation, artificial heart valve regurgitation or stenosis, and tricuspid valve regurgitation associated with pacemaker leads who are referred for clinically-indicated echocardiographic exams at Mayo Clinic, in Jacksonville, Florida will be screened for participation in the study. The plan is to have 292 people take part in this study. This minimal risk study will consist of the recording of patient data, activity and bleeding questionnaires, and collection and analysis of blood samples.  Each blood sample will be analyzed for von Willebrand Factor antigen and activity, and von Willebrand Factor multimers, and BNP. Blood samples will be sent to the Mayo Special Coagulation Lab for analysis.

     Objective:

     This study seeks to assess the degree of association of the von Willebrand Factor activity indices and BNP to the severity of cardiac lesions, and to note a relationship between acquired bleeding the the hematologic abnormalities.  Plasma will be stored in attempt to develop new in vitro tests of von Willebrand factor (VWF) activity.

A prospective randomized, multi-center trial with two population cohorts: 1) patients who are designated to have intermediate risk for surgical aortic valve replacement (Cohort A - operable) and 2) patients who are not suitable for aortic valve surgery (Cohort B - inoperable). Enrollment will consist of up to 2000 patients in Cohort A, up to 500 patients in Cohort B, up to 100 patients each in NR1, NR2, NR3, and NR4 and up to 50 patients each in NR5 and NR6. Study patients will undergo clinical follow-up at discharge, 30 days, 6 months, 1 year and then annually for a minimum of 5 years.