Aortic Stenosis, Severe

The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).

Transcatheter aortic valve implantation (TAVI) has become the standard treatment for patients with severe aortic stenosis across a broad range of surgical risk. Advances in device technology and procedural techniques have enabled minimalist approaches and shorter hospital stays. Preliminary observational studies suggest that same-day discharge after TAVI may be feasible and safe in carefully selected patients, but randomized evidence remains limited, particularly in patients treated with self-expanding valves. The HOME-TAVI trial is a prospective, multicenter, international, randomized controlled trial designed to evaluate whether a same-day discharge strategy is non-inferior to standard hospital discharge after successful transfemoral TAVI with the Medtronic Evolut PRO+/FX/FX+ system. Eligible patients who remain clinically stable 6 hours after the procedure will be randomized in a 1:1 ratio to same-day discharge or standard-of-care discharge. The primary endpoint is a composite of all-cause mortality, type 2-4 bleeding, stroke, and hospital readmission within 30 days after TAVI. Secondary objectives include assessment of quality of life, patient-reported experience measures, healthcare resource utilization, and cost-effectiveness.

Transcatheter aortic valve implantation (TAVI) has evolved into a standard therapy for severe aortic stenosis across all surgical risk profiles, supported by pivotal trials in high- and low-risk populations. Two types of transcatheter heart valves, balloon-expandable and self-expanding, exhibit distinct hemodynamic and structural characteristics that influence procedural strategy and long-term durability. Accurate valve sizing is crucial for procedural success, as both undersizing and oversizing are associated with procedural complications, including aortic regurgitation, conduction disorders, valve embolization, annular rupture, and increased leaflet stress which may impair long-term durability. However, optimal annular sizing remains challenging due to the complex three-dimensional anatomy of the aortic annulus, which is oval, crown-shaped, dynamically deforming, and variably oriented. These anatomical features often lead to "grey zones" in clinical sizing charts, resulting in so-called borderline annuli in which the measured annular dimensions may indicate two suitable valve sizes. Borderline annuli are frequently encountered in patients undergoing TAVI with self-expanding valves (i.e., Evolut transcatheter heart valve series) due to a limited number of sizes (23, 26, 29 and 34 mm). Consequently, under- or oversizing of self-expanding valves is often required. However, sizing of transcatheter heart valves in borderline annuli is associated with a greater likelihood of procedural complications, higher rates of aortic regurgitation, and higher transvalvular gradients.9,11 New generation balloon-expandable valves (i.e., Myval transcatheter heart valve series) are introduced with intermediate (21.5, 24.5, 27.5 mm) and extra-large (30.5, 32 mm) valve sizes that are not available for the Evolut platform. These additional size ranges potentially offer more precise annular sizing, reducing the need for under- or oversizing and improving short- and long-term hemodynamic performance. The SELECT TAVR trial will evaluate whether the expanded size range of the balloon-expandable Myval transcatheter heart valves is noninferior compared to the self-expanding Evolut transcatheter heart valve series in patients with borderline annular dimensions undergoing TAVI with respect to the composite safety end point of the third Valve Academic Research Consortium (VARC-3) at 30 days. Objectives: The primary objective of the current trial is to determine whether the Myval transcatheter heart valve series is noninferior to the Evolut transcatheter heart valve series in patients with borderline annular dimensions undergoing TAVI with respect to the composite safety end point of the third Valve Academic Research Consortium (VARC-3) at 30 days Secondary objectives: The secondary objectives of the current trial include: 1) Hemodynamic performance as assessed by invasive hemodynamic parameters as well as by transthoracic echocardiography at 30 days (+2 months), and longer-term follow-up; and 2) Long-term clinical outcomes with follow-up up to 5 years. Study design: The proposed SELECT TAVR trial is an investigator-initiated, open-label, multicenter, randomized controlled, noninferiority trial with blind end point adjudication. Study population: The SELECT TAVR trial will focus on patients referred for TAVI in whom CT-derived annular dimensions fall within borderline annulus ranges

The VALvosoft Outcomes Registry for Real-World Evidence (VALOR-PMCF) is a prospective, multicenter, single-arm post-market clinical follow-up (PMCF) registry designed to evaluate the long-term safety and effectiveness of the Valvosoft® non-invasive ultrasound therapy (NIUT) device in patients with severe symptomatic calcific aortic stenosis (sSAS). Valvosoft® delivers focused, high-intensity, short-duration ultrasound pulses to the aortic valve via a trans-thoracic approach, inducing non-thermal mechanical softening of calcified valve tissue. This registry will enroll up to 200 participants across approximately 20 clinical sites in Europe following CE marking. Participants will be followed from discharge through 12 months post-procedure to assess clinical outcomes, quality of life, echocardiographic parameters, and safety events in a real-world setting.

The aim of this study is to learn if the Computed Tomography scan (CT scan) and heart echo scan TransThoracic Echo scan (TTE or heart echo scan) taken before a Transcatheter Aortic Valve Implantation (TAVI) procedure can be used to predict how the new TAVI valve will perform in the future. To do this the investigators need the usual CT scan before and a new CT scan after the TAVI valve has been put in. At present a CT scan after TAVI procedure is not routinely done. Male and female patients with severe Aortic Stenosis (AS) will be asked to take part. The data from the scans along with routine measures that are taken will be used to assess if there has been any deterioration in the valve at six months. The scan data collected will be used in a computer programme. This programme will be trained to predict TAVI valve performance. The main purpose of this study is to collect the CT scan data before and after the TAVI procedure. The study aims to answer: • Can the investigators obtain additional CT imaging data and other data before and after TAVI to enable the prediction of valve performance? Participants will be asked if they would have another CT scan 6 months after their TAVI procedure, during their routine follow up.

The goal of this interventional is to assess advantages of the ultrasound examination of the lungs in the early postoperative period in cardiac surgical patients after heart surgeries requiring cardiopulmonary bypass. Evaluation of pulmonary complications and outcomes during mid-term follow-up, as well as comparison of ultrasound examination and traditional roentgenologic methods (X-ray examination and CT of the chest) will be performed. The main question\[s\] it aims to answer are: * Is ultrasound examination of the lungs a more specific and sensitive method in identification of early postoperative pulmonary complications after on-pump cardiac surgical procedures, in comparison with traditional X-ray methods. * Does early identification of interstitial pulmonary edema (based on number of visualised B-lines in the early postoperative period), influences mid-term outcomes in this cohort of patients Participants will undergo ultrasound examination of the lungs on postoperative day 1, 3, 5 and 7 after heart surgery. Based on ultrasound findings and degree of interstitial pulmonary edema, medical (diuretics, anti-inflammatory, e.t.c) therapy will be modified. Researchers will compare this group of patients with control group, in which ultrasound examination will be performed in the same time frames, but no changes in medical management based on ultrasound findings will be made to see if timely administered medical therapy, based on ultrasound findings, can significantly improve symptoms, hospital lengths of stay and outcomes of this patients.

The TACTIC-TAVI registry aims to collect information about a consecutive cohort of patients undergoing transcatheter aortic valve insertion. The registry is international, multi-centre and observational. The registry is planned to continue until the calculated sample size is achieved.

This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.

Patient with paradoxical or conventional low-flow low-gradient aortic stenosis on echocardiographic assessment will undergo physiological exercise-stress CMR in addition to guideline recommended surveys prior to TAVR.

This study will investigate changes right ventricular function and functional recovery metrics after transcatheter aortic valve implantation