View clinical trials related to Aortic Regurgitation.
Filter by:To evaluate the safety and effectiveness of the SAPIEN XT (Edwards Lifesciences, Irvine, California) transcatheter heart valve implantation (TAVI) in Chinese patients with symptomatic severe calcific aortic stenosis who are considered at high risk for surgical valve replacement.
Aortic valve replacement with a biological prosthesis is the most common valve surgery performed with about 1000 operations performed in Denmark each year. Further, the introduction of percutaneous stent valves will increase these types of replacements in the years to come. A biological valve is a foreign body prone to cause thrombus formation at least until the valve is covered with recipient endothelium. There are no conclusive studies of anticoagulation and the investigators have shown stroke to be a common complication. Guidelines have variably recommended aspirin or rivaroxaban for anticoagulation, and currently aspirin is the most common recommendation. In a register study, the investigators have shown that proper anticoagulation with warfarin is likely to be superior. There is a clear need for a large randomised study of aspirin versus anticoagulation for biological aortic valve replacement. This protocol describes a randomised study where 1000 patients will be randomised to receive either rivaroxaban or aspirin for 6 months following aortic valve replacement with a biological prosthesis. The primary efficacy endpoint is a combined event of all-cause mortality and hospitalisation for either acute myocardial infarction or stroke. This study has the power to settle a discussion of appropriate anticoagulation for this operation
To collect information about treatment for severe Aortic Regurgitation (AR), which affects the aortic valve in the heart. Aortic regurgitation is a condition where aortic valve in the heart does not close tightly and allows some blood to leak back into the heart chamber. Symptoms of aortic regurgitation may include fatigue and shortness of breath. The preferred treatment for severe aortic regurgitation is aortic valve replacement surgery.
During general anesthesia a reduction of Functional Residual Capacity (FRC) was observed. The reduction of FRC could imply that respiratory system closing capacity (CC) exceeds the FRC and leads to a phenomenon called expiratory flow limitation (EFL). Positive End-Expiratory Pressure (PEEP) test is a validated method to evaluate the presence of EFL during anesthesia. Aim of the study will be to asses if mechanical ventilation during CardioPulmonary Bypass (CPB) in cardiac surgery could reduce the incidence of EFL in the post-CPB period. Primary end-point will be the incidence of EFL, assessed by a PEEP test, performed at different time-points in operating room. Co-primary end-point will be shunt fraction, determined before and after surgery. This will be a single center single-blind parallel group randomized controlled trial. Patients will be randomly assigned to four parallel arms with an allocation ratio 1:1:1:1, to receive one of four mechanical ventilation strategies during CPB. 1. Ventilation with a Positive End-Expiratory Pressure (PEEP) of 5 cmH2O before and after CPB; Continuous Positive Airway Pressure (CPAP) during CPB; 2. Ventilation without PEEP before and after CPB; CPAP during CPB; 3. Ventilation with a PEEP of 5 cmH2O before and after CPB; No use of mechanical ventilation during CPB 4. Ventilation without PEEP before and after CPB; No use of mechanical ventilation during CPB
Prospective, non-randomized, multicenter post-approval study to collect long term clinical and echographic data on Mitroflow DL patients.
Prospective longitudinal study on four small groups of surgical patients affected by: BAV with isolated regurgitation, BAV associated with aorta dilatation, or both and BAV with isolated stenosis in over 60 year-old patients. The aim of the study is to select homogeneous small groups of surgical patients with the same subtype of BAV and same aortic behaviour and identify markers/predictors of favorable-unfavorable aortic wall evolution to evaluate if there is a BAV phenotype more likely to be considered at high risk for aortic degeneration.
The purpose of this registry is to observe longterm performance and safety of the JenaValve TAVI system, in routine medical and everyday conditions.
This investigation is a prospective, non-randomized, multi-center trial to evaluate the safety and effectiveness of the HAART model 300 annuloplasty ring when used to surgically repair a leaking aortic valve using a 3-D intra-annular mounting frame
Follow-up study in patients with severe aortic regurgitation after successful valve replacement. Systolic and diastolic function were assessed and persistent diastolic dysfunction was observed late (7-10 years) after operation.
Velocity Vector Imaging may provide reliable and detailed information on left ventricular segmental function in asymptomatic patients with moderate-to severe AR. This may help to identify subclinical myocardial dysfunction in order to operate early enough to prevent postoperative heart failure and restrict unnecessary early operation which could be associated with operative risks and mortality related to prosthetic valves.