View clinical trials related to Aortic Stenosis.
Filter by:100 subjects in the each of the treatment arms of the study (total 200 treatment arm subjects) and up to 100 subjects in the registry arm of the study.
To evaluate the safety and effectiveness of the SAPIEN 3 (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.
The trial objective is to investigate whether Fractional Flow Reserve (FFR)-Guided Percutaneous Coronary Intervention (PCI) and TransCatheter Aortic Valve Implantation (TAVI) strategy for treatment of multivessel disease and aortic stenosis will be non-inferior to Coronary Artery By-pass Grafting (CABG) and Surgical Aortic Valve Replacement (SAVR) for a composite primary endpoint of all-cause mortality, stroke, myocardial infarction, coronary or valve re-intervention and life-threatening or disabling bleeding at one year.
The primary objective of this study is to evaluate the real-world performance of the CoreValve Evolut PRO transcatheter aortic valve, including leaflet function, in a prospective observational registry.
To date, no formal, randomized, prospective, head-to-head comparisons of surgical aortic valve replacement (SAVR) versus transcatheter aortic valve replacement (TAVR) have been undertaken in the severe aortic stenosis (AS) population with small aortic annuli. Objectives of the present study are to compare the hemodynamic performance (incidence of severe PPM and ≥ moderate AR) and clinical outcomes (death, stroke, major or life threatening bleeding) between TAVR and SAVR in patients with severe AS and small aortic annuli.
This is a pilot study in which we will aim to demonstrate successful execution of the imaging protocol and to make observations regarding the calcification activity as measured by 18F-NaF PET/CT and any correlation to 1) valve age and valve type, and 2) subsequent degeneration of aortic valve bioprostheses based upon clinical, echocardiographic and CT parameters. Additionally, the data will serve as preliminary data to plan a larger study to investigate study objectives.
Study category and Rationale Clinical study, Category A. Clinical Phase: Post market study Background and Rationale: Left atrial appendage occlusion (LAAO) allows avoiding oral anticoagulation and provides at the same time an at least equally good protection from strokes and peripheral embolism. It may therefore be an attractive alternative to oral anticoagulation in the patient population undergoing transcatheter aortic valve implantation (TAVI): the concept of LAAO is based on the fact that thrombus formation in atrial fibrillation occurs in >90% in the left atrial appendage (LAA). Mechanical occlusion of the LAA reduces the stroke risk by eliminating the source of thrombus formation. In the here proposed "Randomized Comparison of Left Atrial Appendage Occlusion versus Standard Medical Therapy in Patients in Atrial Fibrillation Undergoing Transfemoral Transcatheter Aortic Valve Implantation", study we test the hypothesis, that LAAO is superior to standard medical therapy in the high-risk TAVI population. This hypothesis has not been investigated by previous studies so far. Overall Objective(s): Overall objective: to compare the safety (and efficacy) of LAAO using the St. Jude left atrial appendage closure device with standard medical therapy in a prospective, multi-center, randomized trial in patients undergoing TAVI in routine clinical practice. Primary Objective: To assess the safety of the device intervention with regard to stroke prevention and prevention of bleeding complications in a patients population at high risk of stroke and bleeding. Secondary Objectives: Short-term (procedural) safety of device intervention is assessed (rate of successful deployment of a left atrial appendage occluder; rate of kidney failure). As a further secondary objective, long-term effects of device intervention on stroke and bleeding prevention as well as mortality are assessed and compared to medical therapy. Outcome(s): Primary: Composite endpoint of ischemic and hemorrhagic neurologic events, peripheral embolism, life-threatening/disabling and major bleeding complications and cardiovascular mortality at 1 year Secondary: All deaths (cardiac and non-cardiac) at 30 days, 1, 3, and 5 years Device success at 30 days In-hospital acute kidney injury (AKI) Study design: An investigator-initiated, randomized, multicenter, non-blinded, all-comers study Measurements and Procedures: 80 patients in atrial fibrillation undergoing TAVI will be randomized in a non-blinded fashion (1:1 randomization) to LAAO (device group) or SMT at the operators' discretion (medical group; antiplatelet therapy and oral anticoagulation or oral anticoagulation alone). All patients will be followed for up to 5 years. The primary analysis will be performed at 30 days and after completion of a 1-year follow-up. 80 patients in atrial fibrillation undergoing TAVI will be randomized in a non-blinded fashion (1:1 randomization) to LAAO (device group) or standard medical therapy (SMT) at the operators' discretion (medical group; antiplatelet therapy, oral anticoagulation or oral anticoagulation alone). Estimated duration for the main investigational plan from start of screening of first participant to last participant processed and finishing the study: 6 years
A single arm, prospective, open, non-randomized, Japanese multicenter trial to evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve System (Model: 9600TFX) in the treatment of symptomatic severe aortic stenosis patients on chronic dialysis, who are determined by the heart team to be unable to undergo safe open surgical therapy and have the benefits of the study valve implantation. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.
Currently catheters used in heart catheterization procedures are guided throughout the heart chambers and blood vessels by pictures taken by x-rays. This technology exposes patients to radiation. With this study protocol the investigators will use MRI technology to take real-time pictures to navigate catheters throughout heart chambers. MRI uses electromagnetic energy; therefore, it does not expose participants to radiation energy.
Aim of the study is to demonstrate equivalence of second-generation self-expandable valves (CoreValve Evolut R) in comparison to second-generation balloon-expandable valves (Edwards Sapien 3) and of local anesthesia with conscious sedation in comparison to general anesthesia with respect to safety and efficacy in high-risk patients with severe aortic stenosis undergoing transcatheter aortic valve implantation.