View clinical trials related to Aortic Stenosis.
Filter by:Since its first clinical introduction by Alan Cribier in 2002, transcatheter aortic valve implantation has become the treatment of choice for severe aortic stenosis in high-risk and elderly patients. In such a population, cardiac surgery after TAVI is seldom performed (<1%), and only in cases of life-threatening complications such as device embolization, heart rupture, aortic dissection, endocarditis, etc. - State-of-the-art Nowadays, patients submitted to TAVI are getting younger, with lower surgical risk and longer life-expectancy, and their number is continuously increasing . As a consequence, the number of patients treated with TAVI who will require subsequent cardiac surgery will also expand, both acutely (due to the above-mentioned complications) and during follow-up (due to late endocarditis, valve degeneration and other non-aortic indications). - Previous informations Despite cardiac surgery after TAVI has been already performed several times across the world without documented issues in regard to aortic cross-clamp and aortotomy, it has been long debated whether the presence of TAVI devices with a tall stent frame in the ascending aorta may theoretically jeopardize the ability of surgeons to clamp and open the aorta. No specific data is yet available in regard to the existence and the incidence of such issue. - Ethical issues Not present. Aim of the study The aim of this study was to assess the anatomical feasibility of surgical aortic cross-clamp and aortotomy after TAVI based on post-TAVI computed tomographies (CT). Study design This study enrolled patients who underwent TAVI in three high-volume centers (San Raffaele University Hospital in Milan - Italy, Rigshospitalet Univeristy Hospital in Copenhagen - Denmark, Semmelweiss University in Budapest - Hungary) between October 2008 and May 2017. 117 CT acquired after TAVI procedures that were cardiac-gated and included the aortic arch into the field of view were retrospectively reviewed. 11 patients of San Raffaele Hospital will be involved. Reasons for post-TAVI acquisition were: participation into a clinical study with a previous Ethical Committee approval (91.4% n = 107); residual aortic regurgitation assessment for Valve-in-Valve evaluation (6.0% n = 7); TAVI complication assessment (ventricular septum defect 1.7% n = 2, left ventricular outflow tract obstruction 0.9% n = 1). Median time of CT acquisition after TAVI was 451 [290-780] days. As per study design, only TAVI devices with a long stent were assessed: CoreValve (Medtronic Inc., MN, USA) n = 82 (size 26 n = 23; size 29 n = 48; size 31 n = 11); CoreValve Evolut R (Medtronic Inc., MN, USA) n = 19 (size 23 n = 1; size 26 n = 7; size 29 n = 10; size 34 n = 1); Portico (Abbott, IL; USA) n = 16 (size 25 n = 9; size 27 n = 4; size 29 n = 3). Acurate Neo device (Boston Scientific, MA, USA, former Symetis) presents three stabilization arches in the ascending aorta which differ this prosthesis from the circular tubular stent of other self-expandable valves. To limit the introduction of possible confounding factors in the analysis, the investigators decided on purpose not to include the Acurate in the present study. Indication for TAVI respects international guidelines (EACTS 2017 Guidelines for Treatment of Valvular Heart Disease). A transthoracic examination is performed before the procedure at hospital admission. The in-hospital pathway pf examination is equal to every other patient treated in the participating centers.
Aortic stenosis is a progressive disease that affects approximately 3% of adults aged 75 and over. If left untreated, the mortality rate of aortic stenosis, which becomes symptomatic in a short time, is 50% in the first year, while this rate rises to 90% within 5 years. Surgical treatment of aortic stenosis has been proven to reduce symptoms and increase survival. Although surgical treatment is considered the gold standard, 30% of elderly patients cannot undergo surgery due to left ventricular dysfunction and comorbidities. The search for new methods with a low-risk rate and a more comfortable post-procedure process has begun. For this purpose, Cribier et al. Transcatheter aortic valve implantation (TAVI) was developed in 2002 as an important alternative to surgical aortic valve placement. The TAVI method; is the procedure of inserting a bioprosthetic aortic valve into the heart using the catheter method without open heart surgery. Although transcatheter aortic valve implantation is more tolerable than surgery, it has certain complications. According to the Valve Academic Research Consortium (VARC-3), common post-procedural complications are; stroke, myocardial infarction, bleeding, major vascular complications, and acute kidney injury. Nursing-specific care problems are stated as bleeding, infection, pain, decrease in cardiac output, and sleep problems. Many factors, such as the high risk of patients undergoing TAVI, the complexity of the procedure, and the complications that may develop after the procedure, require that the nursing care to be applied be specific and individualized to the TAVI procedure. It is very important to understand the experiences of the patients to effectively carry out this special care to be applied before and after TAVI. It is known that being aware of the experiences and needs will contribute positively to the care and treatment of future patients. Instens et al. stated that experiences can be reached by examining perspectives in depth rather than clinical studies or records. In this regard, Baumbusch et al. in their qualitative design study; It has been revealed that TAVI patients cannot manage their care after the procedure because of their age and comorbidities, there is a difference between their expectations and reality, and they need support in terms of information. In another study, the post-TAVI process was defined as a balance between the struggle for life and hope, and the importance of the support of health professionals during the process was emphasized. For these reasons, TAVI patients need nursing care support and information in terms of post-procedure disease management. The most important component of successful disease management is to increase the participation of the individual in his health. In this direction, nurse-led training and counseling programs are the leading methods that will increase the participation of patients in their health management, and research on this subject has been increasing in recent years. Jiang et al. In their study on patients with myocardial infarction, it was found that a nurse-led training and counseling program increased the quality of life and risk factor control. Boyne et al. In their study of heart failure patients, it was revealed that the knowledge, self-care, and self-efficacy of the patients increased after the intervention. Despite growing evidence for the benefits of nurse-led education and counseling programs, no studies have been found with TAVI patients who might need this intervention the most. The aim of this study; is to examine the effect of education and follow-up program on quality of life, self-care, treatment compliance and hospital readmission in patients who underwent TAVI.
To evaluate feasibility and safety of the ACURATE Prime™ XL Transfemoral Aortic Valve System for transcatheter aortic valve implantation (TAVI) in subjects with severe native aortic stenosis who are indicated for TAVI.
The objective of this data-collection study is to retrospectively evaluate the safety and clinical performance of the Portico transthoracic aortic valve for Valve-in-Valve treatment of a failed aortic surgical bioprosthetic valve in patients who are considered at increased surgical risk for a redo surgical aortic valve replacement.
CT scans of the chest / thorax are of great importance both in the initial diagnosis and in the follow-up of pulmonary or thoracic diseases. As an example, CT angiography of the pulmonary arteries (CTPA) is worldwide considered to be gold standard test in patients with a suspicion for pulmonary embolism. The aim of this study is to measure and compare dose efficiency of modern CT scanners for unenhanced and contrast-enhanced scan protocols of the chest/thorax. Patients who are referred for a CT of the chest/thorax will be randomly assigned to one of the three CT scanners currently in use at our institution.
The TaurusOne® transcatheter aortic valve system with retrievable delivery catheter system is evaluated the safety and effectiveness for the delivery of artificial aortic valve in a prospective, multicenter, single-arm clinical trial.
The objective of this study is to evaluate the safety and performance of the transShield Embolic Protection System (EPS) used for embolic protection during Transcatheter Aortic Valve Replacement (TAVR).
This study plans to investigate the relationship between cognitive status pre-procedure, and clinical outcomes at 3 months in patients undergoing transcatheter aortic valve implantation (TAVI).
Non-contrast enhanced cardiac MRI using 3D whole heart acquisition protocol is non-inferior to contrast enhanced CT in the assessment of aortic annulus complex for pre-TAVR imaging.
This is a prospective single center Cardiology department observational study. The study aim is to better understand the predictors of high grade conduction abnormalities associated with TAVR such that a more robust evidence-based and universal strategy to manage cardiac conduction disturbances in these patients, which has been elusive, can be developed.