Aortic Stenosis

This trial aims to improve the heart health of people with a narrowed aortic valve called aortic stenosis (AS) who then have aortic valve replacement (AVR) by assessing the change in the mass of the left ventricle. Even after an AVR in many patients the heart is still unable to pump as well and can lead to heart failure. This study will assess if medication used in other causes of heart failure can help participants having an AVR recover better. Researchers will compare two drugs, dapagliflozin and spironolactone, that have been shown to help patients with heart failure who do not have AS, to see if taking one or both medicines together will help patients with AS. There will be four treatment arms: dapagliflozin, spironolactone, dapagliflozin and spironolactone together, and standard of care. These will be taken as one tablet of each IMP per day for 12 months. Participants will have approximately four follow up visits, dependent on the treatment arm - those in an arm with spironolactone will have an extra safety follow up visit. These medicines might help patients after AVR by reducing heart muscle thickness and scarring.

Biomarkers and mechanisms in the progression of aortic valve stenosis are sometimes not sufficiently understood. The current project will take into account image morphological and immunological aspects that predict the development of hemodynamically relevant aortic valve stenosis in order to identify high-risk patients and to develop further therapeutic options.

The objective of this study is to demonstrate safety and efficacy of the EmStop Embolic Protection System when used as indicated to capture and remove thrombus/debris during self-expanding transcatheter aortic valve replacement (TAVR) procedures.

The purpose of this study is to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) administered subcutaneously once monthly compared to placebo in slowing the progression of calcific aortic valve stenosis.

The Echo-AVCS Study is an investigator-initiated, prospective, multicenter observational study designed to derive and validate an artificial intelligence (AI)-based echocardiographic aortic valve calcium score (Echo-AVCS) for confirming severe aortic stenosis (AS). Transthoracic echocardiography (TTE) is the standard imaging modality for assessing AS severity; however, discrepancies between valve area and transvalvular gradient measurements may complicate diagnosis, particularly in low-flow or discordant AS presentations. Cardiac computed tomography (CT)-derived aortic valve calcium scoring is currently used to resolve diagnostic uncertainty, but it involves additional cost and radiation exposure. This study will enroll consecutive adult patients undergoing clinically indicated TTE and cardiac CT with calcium scoring performed within 3 months. Standardized echocardiographic images will be centrally analyzed using dedicated AI-based image segmentation and machine learning methods to quantify aortic valve calcification directly from TTE images. CT-derived aortic valve calcium score will serve as the reference standard. The primary objective is to derive and validate the Echo-AVCS score for identifying severe AS. Secondary objectives include determination of sex-specific diagnostic thresholds, correlation with CT calcium volume, association with symptoms and NYHA class, and evaluation of prognostic associations with aortic valve replacement, heart failure hospitalization, cardiovascular events, and mortality at 1-year follow-up.

The purpose of this study is to see if having the Transcatheter Aortic Valve Replacement (TAVR) procedure done in a hospital with onsite cardiac surgery available or not, makes a difference on participant outcomes. Current standard of care is to have this procedure done in a hospital with onsite cardiac surgery available. Hypothesis The investigators hypothesize that the TAVR in experienced interventional cardiac centers without on-site cardiac surgery will be safe and effective. Although this is happening clinically in select regions internationally, this change in the clinical application of TAVI requires a rigorous assessment of safety with a robust randomized trial and multicenter international collaboration.

Aortic stenosis is a condition in which the aortic valve becomes narrow and does not open properly, making it harder for the heart to pump blood to the body. Transcatheter aortic valve implantation (TAVI) is a minimally invasive procedure commonly used to treat this condition, especially in older patients or patients at high surgical risk. Many patients undergoing TAVI also have leakage of the mitral valve and/or tricuspid valve. These valve problems can cause symptoms such as shortness of breath, fatigue, swelling, heart failure, and repeated hospitalizations. Patients with multiple valve diseases generally have worse outcomes and are more difficult to treat. In some patients, mitral or tricuspid valve leakage improves after TAVI because the heart works better once the aortic valve has been treated. However, in other patients, the leakage remains severe and continues to affect their health and quality of life. New minimally invasive treatments are now available to repair or replace the mitral and tricuspid valves, but doctors still do not know the best order or timing for these procedures. This study aims to evaluate a treatment algorithm for patients with severe aortic stenosis and significant mitral and/or tricuspid valve leakage. The proposed approach follows current clinical guidelines and uses a stepwise strategy. Patients will first undergo TAVI, followed by reassessment of the mitral and tricuspid valves. If important valve leakage persists after TAVI, additional minimally invasive procedures may be considered to treat the mitral or tricuspid valve. The study will include patients with severe aortic stenosis and moderate-to-severe or severe mitral and/or tricuspid regurgitation. Researchers will collect information about patient symptoms, heart imaging results, procedures, hospitalizations, quality of life, and clinical outcomes during follow-up. The main goal of the study is to evaluate whether this staged treatment approach is safe, feasible, and effective in improving patient outcomes. Researchers will also assess whether the strategy can reduce hospitalizations for heart failure and improve symptoms, daily functioning, and quality of life. The results of this study may help doctors better manage patients with multiple valve diseases and provide a more personalized and structured treatment approach for this complex group of patients.

The purpose of this study is to generate clinical evidence on valve safety and performance in subjects treated by redo Transcatheter Aortic Valve Replacement (TAVR).

TRACS-PRIME is a prospective, randomized, multicenter clinical trial evaluating whether transcatheter aortic valve implantation (TAVI) can be performed safely and effectively in selected hospitals without on-site cardiac surgery, when appropriate patient selection, experienced operators, advanced imaging, and established transfer pathways are available. The study will include patients with severe symptomatic aortic stenosis who have an indication for TAVI confirmed by a multidisciplinary Heart Team. Eligible patients will be randomized to undergo TAVI either in a center without on-site cardiac surgery or in a center with on-site cardiac surgery. All procedures will be performed according to current standards of care by experienced TAVI operators. The main purpose of the study is to determine whether TAVI performed in centers without on-site cardiac surgery is not inferior to TAVI performed in centers with on-site cardiac surgery with respect to clinical outcomes at 1 year. The primary clinical outcome includes death from any cause, stroke, or hospitalization related to the procedure or the implanted valve. The study will also assess safety outcomes, including valve-related death and major procedural or technical complications. Participants will be followed after hospital discharge to assess clinical events, safety, and longer-term outcomes. An independent committee blinded to treatment allocation will review clinical events, and an independent Data Safety Monitoring Board will monitor patient safety during the trial.

Aortic stenosis, a common cardiovascular disease, is pathophysiologically associated with a chronic inflammatory myocardial reaction and fibrosis leading to cardiac dysfunction and impaired coronary perfusion. These elements may precede the onset of symptoms. The assessment of inflammatory and fibrosis factors (in particular by means of biomarkers) in patients with aortic stenosis will make it possible to identify asymptomatic patients at greater risk who could benefit from intervention earlier. This is part of a personalised medicine adapted to the patient. Patients will be recruited during their TAVI (Transcatheter Aortic Valve Implantation) assessment consultation. If the patient agrees to take part in the study, information relating to routine care procedures will be collected (patient history, clinical examinations, electrocardiogram, echography, coronary angiography, TAVI procedure if applicable, biology). Outside of routine care, a biocollection will be established (serum, plasma), quality of life questionnaires will be carried out and adverse events will be collected where present. Patients will be divided into 3 groups according to the indication for TAVI (Group A - symptomatic severe aortic stenosis with indication for TAVI, Group B - asymptomatic severe aortic stenosis without indication for TAVI, Group C - asymptomatic moderate aortic stenosis without indication for TAVI). The main objective is to compare the levels of biomarkers of inflammation and fibrosis between the 3 groups at each sampling time common to all three groups between inclusion and 1-year follow-up.

This study will compare the amount of cerebral microembolization during transcatheter aortic valve implantation (TAVI) between two commonly used types of transcatheter aortic valves: balloon-expandable valves and self-expanding valves. Cerebral microembolization refers to small particles or material that may travel to the brain during the procedure. These signals can be detected using transcranial Doppler ultrasound, a non-invasive method for monitoring blood flow in the brain. Although clinically apparent stroke after TAVI is relatively uncommon, small silent brain lesions may occur, and their mechanisms are not fully understood. Adult patients with severe symptomatic aortic valve stenosis who are scheduled for TAVI will be included. Participants will be randomly assigned to receive either a balloon-expandable or a self-expanding valve, both of which are established and routinely used treatment options. Transcranial Doppler monitoring will be performed before, during, and after the procedure to record the number of microembolic signals. The study will also record neurological events and procedural characteristics, such as procedure duration and the need for balloon dilatation. The aim of the study is to determine whether the type of valve is associated with a different burden of cerebral microembolization during TAVI. The results may help improve understanding of procedural factors related to cerebral embolization and may support future strategies for reducing neurological risk in patients undergoing TAVI.

This prospective, multicenter, observational cohort study aims to establish a post-market registry framework to evaluate the real-world clinical applicability, long-term safety, and effectiveness of innovative heart valve devices in China.

This trial aims to improve the heart health of people with a narrowed aortic valve called aortic stenosis (AS) who then have aortic valve replacement (AVR) by assessing the change in the mass of the left ventricle. Even after an AVR in many patients the heart is still unable to pump as well and can lead to heart failure. This study will assess if medication used in other causes of heart failure can help participants having an AVR recover better. Researchers will compare two drugs, dapagliflozin and spironolactone, that have been shown to help patients with heart failure who do not have AS, to see if taking one or both medicines together will help patients with AS. There will be four treatment arms: dapagliflozin, spironolactone, dapagliflozin and spironolactone together, and standard of care. These will be taken as one tablet of each IMP per day for 12 months. Participants will have approximately four follow up visits, dependent on the treatment arm - those in an arm with spironolactone will have an extra safety follow up visit. These medicines might help patients after AVR by reducing heart muscle thickness and scarring.

AoS-SEDAI study is an observational, multicenter, retrospective and prospective clinical study. This study aims to assess Willem Artificial Intelligence (AI) ability to distinguish between aortic stenosis (AS) and non-AS patients from 12-lead electrocardiogram (ECG) data.

In China, bicuspid aortic valve (BAV) represents a significantly high proportion of the transcatheter aortic valve replacement (TAVR) population. The application of TAVR in patients with BAV is challenging due to complex anatomy. To date, no prospective study has evaluated the Sapien 3 TAVR in patients with Type-0 BAV.

The purpose of this study is to evaluate the effectiveness of impedance cardiography (ICG), the HYPERGRAPH test, in detecting left ventricular decompensation in patients with aortic stenosis, compared to cardiac magnetic resonance (CMR) imaging findings. The study aims to obtain usable ICG test data on six patients with aortic stenosis who have recently undergone CMR scans with late gadolinium enhancement, and who do not have a history of myocardial infarction or cardiac amyloidosis. The hypothesis to be tested is that the HYPERGRAPH can accurately detect left ventricular decompensation associated with replacement fibrosis obtained from CMR imaging.

To compare outcome in patients randomized to treatment with Evolut FX versus Sapien 3 Ultra Resilia.

The APTA (Alternative Peripheral TAVI Accesses) registry is an observational multi-center, retrospective and prospective study, including high and medium - risk patients with aortic stenosis (AS) contraindicates for trans-femoral TAVI, treated with TAVI thought to peripheral accesses. Upper Silesian Medical Center, Katowice and the other hospitals will be involved in the study.

The goal of this clinical trial is to learn if acute transcatheter aortic valve implantation (TAVI) is superior to standard treatment (stabilization in an intensive care unit and TAVI subsequently) to treat cardiogenic shock in patients with critical severe aortic stenosis. The main questions it aims to answer are: • Does acute TAVI increase survival compared with standard treatment? Participants will: * Undergo either TAVI within 12 hours after admission or stabilization and TAVI 72 hours or more after admission * Visit an outpatient clinic and be evaluated for quality of life and heart function

Aortic stenosis (AS) is a common valvular heart disease whose prevalence increases markedly with age-approximately 2-4% in individuals aged 65 years and older, and up to 3.4% for severe AS in those over 75. Degenerative calcific AS predominates in high-income countries, whereas rheumatic disease remains a major cause in low-income regions. With global population aging, the disease burden of AS continues to rise. Transcatheter aortic valve replacement (TAVR/TAVI), owing to its minimally invasive nature, has become an important treatment option for severe AS and selected aortic regurgitation patients, expanding from high-surgical-risk populations to those at intermediate and low risk. In recent years, the number of TAVR procedures in many regions has surpassed or approached that of surgical aortic valve replacement, and major clinical guidelines have elevated TAVR to a recommended standard therapy. Conventional TAVR relies on combined fluoroscopic and echocardiographic guidance. However, perioperative complications remain frequent in elderly and high-risk patients, particularly acute kidney injury (AKI), which significantly increases short- and long-term mortality. Contrast exposure during the procedure is a major contributor to AKI; thus, clinical practice increasingly favors strategies that minimize contrast use, such as low-dose and low-kV imaging. Elevated contrast concentration in the renal tubules increases viscosity, prolongs renal exposure, and can lead to tubular injury and renal dysfunction. Continuous radiation exposure during vascular access, device positioning, valve deployment, and post-release assessment also poses safety concerns for both patients and medical staff. Echocardiography-only guidance for TAVR has therefore emerged as an attractive alternative, with the potential to replace fluoroscopy and contrast for anatomical visualization and device positioning, thereby reducing radiation exposure and contrast-related kidney injury. However, no prospective randomized study has directly compared echocardiography-only guidance with conventional fluoroscopy-plus-echocardiography guidance, and current evidence remains preliminary. To address this gap, a randomized controlled trial was designed to evaluate whether echocardiography-only guidance is non-inferior to combined fluoroscopic and echocardiographic guidance in terms of device success, while also assessing the safety, efficacy, and clinical feasibility of both approaches.

Heart disease is the leading cause of death in the United States, and echocardiography (or "echo") is the most common way doctors look at the heart. Echo is safe, painless, and can detect major heart problems, including weak heart pumping and valve disease. Valve disease, especially aortic stenosis (narrowing) and mitral regurgitation (leakage), is common in older adults but often goes undiagnosed. While echo is the main tool for finding valve problems, it takes time, requires expert training, and results can vary between readers. Recent advances in artificial intelligence (AI), especially deep learning (DL), have shown promise in automatically analyzing heart images. However, past research hasn't fully tackled key echo techniques-like color Doppler and spectral Doppler-that are crucial for measuring how blood moves through heart valves. AI tools also face challenges in being used in everyday medical practice because of workflow issues, lack of real-world testing, and concerns about how the algorithms make decisions. At Columbia University Irving Medical Center, researchers have built a large database of heart tests over the last six years and developed AI programs to analyze echocardiograms. The current study will test whether providing AI analysis to cardiologists in real time during echo reading can make the process faster and more consistent.

To evaluate the safety and efficacy of Siegel™ TAVR System in the treatment of subjects with symptomatic severe native aortic stenosis.

Aortic stenosis (AS) represents the most prevalent acquired valvular heart disease in European populations, and transcatheter aortic valve implantation (TAVI) has become the dominant treatment modality for patients with symptomatic severe AS. The latest 2025 ESC guidelines have broadened age-related eligibility, while the procedure still continues to be limited to centres with cardiac surgery on-site (CSOS). This limitation is in place, despite the very low rate of complications requiring emergent surgical conversion. This subsequently, may constrain procedural capacity and contribute to prolonged waiting times, which in turn are associated with increased pre-procedural mortality and heart failure-related hospitalizations. This prospective randomized open-label clinical trial aims to evaluate the safety and feasibility of performing TAVI in selected pilot centers operating without on-site cardiac surgery department (no-CSOS). Selected patients with severe native AS deemed suitable for transfemoral TAVI by a Heart Team will be enrolled. No-CSOS centers must meet predefined criteria, including operators experience, hybrid operating room availability, on-site vascular surgery availability, and established rapid transfer pathways to CSOS centers. The primary endpoint of the study is early 30-day safety based on VARC-3 criteria; secondary endpoints include additional composite outcomes. Patients will be randomly assigned in a 1:1 ratio using a central Web-based system to undergo TAVI either at a CSOS or non-CSOS site. A total of 404 patients (202 per group) is required. The study will inform national strategies and contribute to defining contemporary safety standards for TAVI delivery in no-CSOS centres.

The goal of this prospective observational study is to learn if advanced heart pressure wave analysis (using methods called WIA and REPA) can help predict the success of the procedure and long-term recovery in adults (aged 60-90) with severe Aortic Stenosis who are undergoing Transcatheter Aortic Valve Replacement (TAVR/TAVI). The main questions it aims to answer are: Do changes in heart pressure wave patterns immediately after the new valve is implanted relate to improvements in a patient's quality of life and heart health over the following year? Can these advanced wave measurements better predict major heart complications (MACE) at 30 days, 180 days and 1 year compared to standard clinical tests? Participants will: Undergo a standard TAVR (TAVI) procedure as part of their regular medical care to replace a narrowed heart valve. Have their aortic pressure waves recorded through a catheter during the routine procedure (this happens during the surgery and does not require any additional incisions or invasive steps). Complete quality-of-life surveys (EQ-5D-5L) and clinical assessments before the procedure. Be followed up via telephone calls or electronic health records at 30 days, 180 days and 12 months after the procedure to check on their recovery and overall health status.

Evaluation of clinical outcomes and valve performance of the SAPIEN 3 Ultra Resilia (S3UR) valve over 10 years.