Active clinical trials for "Aortic Valve Stenosis"

This study evaluates whether a preoperative assessment of myocardial contractile reserve by tissue Doppler Imaging and myocardial fibrosis by cardiac magnetic resonance imaging (MRI) can enhance the patient selection and risk stratification to transcatheter aortic valve implantation.

Aortic stenosis results in increased filling pressures of the heart. Size and function of the left atrium may be a marker for more advanced heart disease (heart failure) in patients with severe aortic stenosis, not presenting any apparent symptoms. The goal of this study is to establish the importance and possible implications of left atrial dilation in asymptomatic patients with aortic valve stenosis.

The purpose of this registry is to document the everyday practice in our centers with minimal invasive treatment of patients with aortic valve disease who were considered suitable for transfemoral aortic valve implantation by heart team.

Transcatheter Aortic Valve Implantation (TAVI) is became the gold-standard therapy for patients with severe and symptomatic aortic stenosis with high operative risk or not suitable for surgery. All studies assessed TAVI showed excellent results at short and mid-term follow-up. The current and future development of the devices predict an extension of indications to "intermediate-risk" and younger patients. Therefore, long-term evaluation of these valves is a priority to determine their durability. However, standardized echographic follow-up of patients implanted with TAVI is lacking. Indeed, there was not consensual definition of TAVI degeneration until now. Recently, European Society of Cardiology published echographic criteria to precise and standardized TAVI deterioration based on simple hemodynamic and morphological criteria. In addition, very few studies have been interested in monitoring more than 5 years of these devices. Finally, nowadays we did not know if TAVI evolution is the same as surgical bioprosthesis.

There are patient related risk factors for PPI that can be identified and assessed in retrospective pooling of 1000+ TAVI patient datasets. Retrospective pooling of 6 datasets already available at participating centres (4 sites in Germany, 1 in Zwolle / The Netherlands, 1 in Linköping / Sweden). Additional assessment of calcifications using a CT data core lab. Statistical analysis of the obtained dataset with respect to the objectives of the registry.

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.

This comparative diagnostic accuracy study will determine the accuracy of a noninvasive wearable infrasonic sensor to detect the mechanical, electrical, and hemodynamic function of the cardiovascular system.

This is a prospective observational study, the purpose of which is to: Characterize response of the AV conduction system to TAVR with various prostheses by recording continuous His bundle electrograms during valve placement. Correlate preprocedure ECG features with changes in AV nodal and infranodal conduction during placement of the valve prosthesis. Correlate changes in AV nodal and infranodal conduction during the procedure with risk of developing AV conduction block after TAVR. Assess the contribution of stressing the conduction system by atrial pacing prior to and following TAVR to prediction of postprocedural heart block. Assess the correlation between new onset bundle branch block, site and degree of conduction block or delay and subsequent development of high-grade or complete AV block.

Severe aortic stenosis (AS) is the commonest form of valvular abnormality in the developed world and transcatheter aortic valve implantation (TAVI) is now widely practiced as in many cases is the preferred treatment option over conventional aortic surgery. Several studies have shown that females have an apparent better outcome with TAVI than males. There are a number of possible reasons as to the apparent favourable benefit of TAVI in women including: having both lower rates of moderate / severe aortic regurgitation and peri-procedural mortality, lower rates of bleeding and renal failure, better patient prosthesis match and recovery of left ventricular function with more favourable left ventricular remodelling. We aim to explore the long term outcomes of TAVI between males and females to try and identify specific tailored treatment options. This data will be useful in providing important information regarding gender differences in patients who are treated with transcatheter aortic valve implantation. Data provided will include long term outcomes and predictors of outcome. The study team will then identify and implement strategies to improve outcomes in patients being treated with transcatheter aortic valve implantation.

Transcatheter aortic valve implantation (TAVI) is recommended for patients with severe aortic stenosis (AS) at high to intermediate surgical risk. Despite similar mortality rates compared to surgical aortic valve replacement (SAVR) in this setting, the rate para-valvular leak (PVL) remains higher and has been associated to higher mortality even at mild degree. This is one of the major concerns to extend TAVI to low surgical risk, although the favorable results from PARTNER 3. The presence of moderate to severe PVL after TAVI is associated to a 2- and 3- fold increase in the mortality rate at 30-day and 1-year follow-up, respectively (24-29). Prosthesis-patient mismatch (PPM) adversely affects functional improvement and exercise tolerance, left ventricular (LV) mass regression, and late structural valve deterioration. Many studies have previously investigated PPM after surgical AVR suggesting the presence of this problem in more than 40% of the surgically treated patients. This rate was significantly lower with the balloon-expandable Sapien (Edwards Lifesciences, Irvine, California), with PPM that varied from 8% to 18%, but in both cases (patients harboring TAVI and those with SAVR) the mortality rate was higher in the presence of PPM. Under the hypothesis that there are differences in terms of transvalvular gradients and residual para-valvular leak amongst different balloon-expandable TAVI devices available in the market, the aim of the MATCH-BALL study is to compare the hemodynamic performance of two balloon-expandable TAVI devices, Sapien 3 (Edwards Lifesciences, Irvine, CA, USA) and Myval (Meril Life Sciences Pvt. Ltd., India).