View clinical trials related to Aortic Valve Stenosis.
Filter by:The investigation concerns a prospective, multicenter, single arm safety and performance study evaluating the Medtronic CoreValve system. Approximately 120 patients presenting with symptomatic aortic native valve stenosis necessitating valve replacement which are considered poor surgical candidates, with a high surgical risk, as attested to by both the surgeon and the cardiologist are recruited in the study. Safety and performance will be evaluated at discharge and at 30 days post-procedure. Valve performance and placement will be followed up at 3 and 6 months post-procedure. Further long-term patient follow-up visits will be performed at 12, 24, 36 and 48 months post-procedure.
The proposed investigation is a prospective, multicenter, non-randomized study to evaluate the immediate benefits (at discharge and at 30 days) in terms of performance and safety of the implantation of the Medtronic CoreValve PAV in a failing aortic bioprosthesis. In addition, the study aims to evaluate the performance and the safety of the implantation of the Medtronic CoreValve PAV in a failing aortic bioprosthesis at subsequent annual follow-ups out to 48 months post procedure. These objectives will be achieved through the following endpoints: - Primary safety endpoint - Composite of Major Adverse Events - Primary performance endpoint - Technical and procedural success at discharge Patient Population: Eligible subjects will be at least 75 years old, presenting with a failing aortic bioprosthesis (stenotic, incompetent or mixed) including homograft or stented or stentless heterograft, considered poor surgical candidates and necessitating repeat aortic valve replacement. Up to 20 patients will be included in up to four hospitals.
To evaluate the performance, efficacy and safety of the percutaneous implantation of the CoreValve® prosthetic aortic valve in patients with severe symptomatic native aortic valve stenosis that have an elevated surgical risk
Background: - Computed tomography (CT) creates three-dimensional images based on X-ray imaging. CT is useful for determining treatment approaches for certain diseases, such as calcific aortic stenosis (narrowing of the aorta because of calcium deposits). - Comparing the data received from CT scans with the data received from heart catheterization (which assesses the heart's condition and function) can be used to improve treatment in patients with certain heart conditions. Researchers are interested in looking at the effectiveness of both procedures in assessing possible surgical treatments for patients with calcific aortic stenosis. Objectives: - To analyze cardiac CT scans in conjunction with existing heart scan results to improve treatments for future minimally invasive aortic valve replacement. Eligibility: - Patients 18 years of age and older who have been diagnosed with aortic valve stenosis that may be treated surgically, and who will undergo or have recently undergone heart catheterization. Design: - Participants will have a CT scan within 90 days of the medically necessary heart catheterization, but before any other surgical or catheter treatment. - During the CT scan, patients will be asked to hold their breath intermittently for about 5 to 20 seconds. Patients will be inside the scanner for less than 30 minutes. - Patients will be asked to return in 3 to 7 days for a blood test to check kidney function. - Researchers will analyze the results of the CT scan in conjunction with the previous results from the catheterization to determine possible improved treatment options.
A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; "study valve"), its transfemoral delivery system, and crimper accessories. The trial includes a premarket confirmatory cohort to evaluate the system performance as well as a Post Market Clinical Follow-up phase involving expanded enrollment and long-term follow-up of all patients to evaluate valve performance out to 5 years.
Patients with severe aortic stenosis often suffer from an acquired Von Willebrand syndrome by degeneration of the polymers during passage through the narrow valve leading to turbulences. We hypothesized that the diagnosis of acquired von Willebrand syndrome influence perioperative blood loss in patients undergoing open cardiac valve replacement.
The purpose of this study is to assess the effects of rosuvastatin compared to usual care in patients diagnosed with aortic valvular stenosis. Patients must have a diagnosis of mild to moderate aortic stenosis (AS) and no clinical indication for the use of cholesterol lowering agents. A multi-centre, randomized, double-blind, placebo-controlled study, with a two year recruitment period, and a treatment duration of a minimum of 3 years from the time of the last patient randomized to a maximum of 5 years.
The purpose of this study is to evaluate the cardioprotective effects of a short term infusion of glucose-insulin-potassium (GIK) during heart surgery.
In this mono-center,open,three-armes, controlled, randomized phase I study the progress of aortic valve calcification with and without vitamin K supplementation will be investgated. This will be done by means of measurements of concentrations from osteocalcine and MPG in blood serum, echocardiography, cardiac computed tomography and cardiac MRI
This trial is designed to confirm the clinical safety and effectiveness of the Trifecta valve by establishing associated adverse event rates, clinical status as indicated by New York Heart Association (NYHA) functional classification, hemodynamic performance, and hematology analysis.