Aortic Valve Stenosis

The study is a prospective, crossover, cluster randomized trial in patients undergoing transcatheter aortic valve implantation (TAVI). The study tests whether cephalosporin plus beta-lactam antibiotic with spectrum for Enterococcus faecalis as per procedural prophylaxis is superior to cephalosporin alone in reducing the composite outcome of bacteremia or death at 6 months post-TAVI.

The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects who are at high or greater risk with a failing aortic bioprosthetic valve.

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.

This study is designed to evaluate the success rate of transfemoral implantation of the Hydra THV biological aortic valve prosthesis in patients with severe symptomatic aortic stenosis. The device is used in accordance with its Instructions for Use as a CE-marked transcatheter heart valve system. The study will assess procedural success, device performance, and early clinical outcomes following implantation. Patients undergoing transcatheter aortic valve replacement (TAVR) via the transfemoral approach will be followed to evaluate safety and effectiveness outcomes, including short- and mid-term clinical follow-up.

This is a prospective, single-arm, multi-center, observational, post-market clinical investigation to document the clinical safety and performance of MicroPort CardioFlow VitaFlow Liberty™ Transcatheter Aortic Valve System in the routine practice for the treatment of severe aortic valve stenosis. The primary endpoint is the composite rate of all-cause mortality and stroke with disability at 12 months. Patients will receive transcatheter aortic valve replacement and examinations at the screening, procedure, discharge, and follow-up per local standard of care.

Calcific aortic valve stenosis (CAVS) is a condition in which the aortic valve progressively narrows and stiffens due to calcium deposition, eventually impairing blood flow from the heart to the body. No drug therapy has been proven to slow CAVS progression. Individuals with mild-to-moderate CAVS are managed with periodic monitoring until the stenosis becomes severe, at which point surgical or transcatheter valve replacement is the only treatment option. The goal of this clinical trial is to determine whether vericiguat, an oral soluble guanylate cyclase (sGC) stimulator, can slow the progression of mild-to-moderate CAVS. The primary questions this study aims to answer are: Does vericiguat slow the progression of aortic valve calcium accumulation, as measured by the change in aortic valve calcium score from baseline to 24 months, compared to placebo? The study will compare vericiguat against a placebo (an inactive pill that is identical in appearance but contains no active drug). Both participants and the research team will not know which treatment each participant is receiving throughout the study. Participants will: Take vericiguat or placebo orally once daily for 24 months; Begin treatment at 2.5 mg/day and undergo a stepwise dose increase every two weeks to a target dose of 10 mg/day, provided the drug is tolerated; Attend approximately 8 scheduled study visits over two years, during which they will undergo cardiac imaging examinations (transthoracic echocardiography and non-contrast cardiac CT), blood sample collection, physical assessment, and completion of standardized questionnaires on quality of life and heart failure symptoms; Undergo cardiac magnetic resonance imaging (MRI) at the beginning and end of the study, if there are no contraindications. Approximately 238 participants will be enrolled across roughly 19 hospitals in China.

The VIVALL-2 study is a randomized trial to compare the self-expandable supra-annular Allegra and the balloon-expandable intra-annular Edwards transcatheter valve systems in patients with degenerated biological aortic surgical valve.

This trial evaluates the effectiveness of CardioHeartConnect, an eight-week mobile cardiac rehabilitation intervention using Peloton fitness modules, compared to educational control among patients recovering from transcatheter aortic valve replacement (TAVR). The study aims to improve physical activity, functional capacity, quality of life, and cardiovascular health using wearable devices and a digital engagement platform. A total of 200 patients will be recruited from the UCHealth Structural Heart and Valve Clinic and randomized to either CardioHeartConnect or CardioHeartEd. Participants will be assessed at baseline, 8 weeks, and 12 months using surveys, smartwatch data, and electronic health records.

Transcatheter aortic valve replacement (TAVR) is a well-established alternative to surgical aortic valve replacement (SAVR) for the treatment of patients with severe aortic stenosis regardless of surgical risk. While TAVR and SAVR share some of the benefits and risks, they importantly differ with regards to invasiveness, time to recovery, hemodynamics, as well as options for re-intervention and possibly valve durability. An early benefit of TAVR may be offset by late risks. Therefore, current guidelines of the European Society of Cardiology recommend an integration of patient values and preferences for the selection of the treatment modality. The objective of the TOGETHER trial is to investigate the efficacy of a structured shared decision making approach (SDM) to improve patient-centered outcomes for the choice between SAVR and TAVR. TOGETHER is an investigator-initiated, randomized, open-label, single-center clinical trial. A total of 140 patients referred for treatment of symptomatic severe aortic stenosis and deemed to undergo TAVR or SAVR according to heart team decision will be randomized in a 1:1 ratio to structured SDM or usual care.

In Europe TAVI is now recommended for treatment of aortic valve stenosis from the age of 70 years. When performing TAVI in young patients, lifetime management becomes important in terms of anticipated TAVI-in-TAVI procedures when valve deterioration occures. Especially small aortic annuli represent a special challenge in terms of postprocedural hemodynamics, however intra-annular transcatheter heart valve designs should be the devices of choice to facilitate future TAVI-in-TAVI procedures. Which intra-annular valve design offers ideal clinical and hemodynamic efficacy is unclear. Therefore, an investigator-initiated, randomized controlled trial (BALANCE trial: Balloon- vs. Self-expanding intraannular TAVI in small aortic annuli) was created to elucidate this topic.

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.

Transcatheter aortic valve implantation (TAVI) is a key-hole technique to replace an aortic heart valve that is narrowed and/or leaking. Although TAVI is a safe and effective treatment for a faulty aortic heart valve, the new TAVI valve will not last forever. Because it is a 'tissue' valve (made from the lining of a cow or pig heart), the valve will fail after a period of time as the tissue degenerates. When the TAVI valve fails, a viable treatment option is to perform a 'Redo TAVI' procedure, implanting a second TAVI valve inside the first failing valve. The main purpose of this study is to carefully evaluate patients being treated by Redo TAVI in order to document the short-term and long-term outcomes of the procedure. The study will also obtain information about which factors predict those outcomes. The study will also assess outcomes in patients who present with TAVI valve failure but are not suitable for Redo TAVI, and instead are treated either by open-heart surgery and surgical aortic valve replacement, or by medical therapy (medication). The study will provide doctors the information they need to understand the best way to treat patients who present with TAVI valve failure, and in particular how to perform Redo TAVI procedures with the best possible outcomes for patients.

The main objective of this study is to evaluate the feasibility and safety of the GEMINUS system in patients with severe symptomatic aortic stenosis. This is a prospective, open label, multicentre, single arm, first in human clinical study. Clinical follow up for all patients will be performed at 30 days, 6 months, 1, 2, 3, 4 and 5 years post-implantation

To assess the efficacy and safety of Intravascular Lithotripsy (IVL) in subjects undergoing transfemoral TAVR in patients with severe iliac disease, prohibitive for transfemoral TAVR in patients with severe symptomatic aortic stenosis, otherwise considered for alternative access TAVR. (e.g. trans-carotid)

The study will evaluate the efficacy and safety of transcatheter aortic valve implantation (TAVI) using the Hydra transcatheter aortic heart valve (THV) series, in patients with severe aortic stenosis up to 1-year after the procedure. This will include an evaluation of the preservation of coronary access post implant by attempting to selectively engage both the right and left coronary arteries through standardised angiographic views. The study will also examine the utility of 72 hours of post discharge remote ambulatory continuous electrocardiogram (ECG) monitoring using the novel Checkpoint Cardio System where it is clinically appropriate.

The primary objective of this study (LANDMARK) is to compare the safety and effectiveness of the Myval THV Series with Contemporary Valves (Sapien THV Series and Evolut THV Series) in patients with severe symptomatic native aortic valve stenosis. This study will be done in total 768 subjects (384:384, Myval THV Series vs. Contemporary Valves) The randomisation will be carried out with an allocation ratio of 1:1 between Myval THV Series vs. Contemporary Valves (Sapien THV Series and Evolut THV Series)

The goal of this clinical trial is to compare two strategies for closing the main artery access site in adult patients undergoing transcatheter aortic valve implantation (TAVI) through a blood vessel in the leg (transfemoral access). The main questions it aims to answer are: Does using a single suture device lower the rate of access-related vascular complications compared to using a hybrid combination of a suture device and a plug-based closure device? How do the two closure strategies compare regarding bleeding complications, procedure time, and time to complete vessel sealing? Researchers will compare a single-suture closure strategy to a hybrid closure strategy (one suture plus one plug-based device) to see if using a single suture reduces vessel-related complications and improves patient safety after TAVI. Participants will: Undergo standard pre-procedure screening and TAVI via the main artery in the leg as part of routine medical care. Receive an initial single-suture placement before the large TAVI delivery system is inserted. Be evaluated after sheath removal for initial bleeding control; qualifying participants will then be randomly assigned (1:1) to either receive no additional device (single suture group) or receive a plug-based closure device (hybrid group). Have their heart and access site monitored during hospitalization, including laboratory checks and imaging prior to discharge. Complete a 72-hour safety and complication evaluation.

The optimal pharmacological therapy after transcatheter aortic valve implantation (TAVI) to prevent valve thrombosis and reduce thromboembolic complications without significantly increasing the risk of bleeding is not yet fully defined and constitutes an important unmet clinical need. Recently, single antiplatelet therapy (SAPT) with Aspirin has been increasingly adopted to avoid bleeding early after TAVI compared with dual antiplatelet therapy. However, TAVI population is affected by a diversity of chronic pathologies that increase the risk of post-TAVI ischemic complications. Stroke is prevalent, especially peri- and early post-TAVI (\<1-8% in the 1st year). Although peri-TAVI myocardial infarction (MI) is rare (1-3%), concomitant coronary artery disease (CAD), diabetes mellitus (DM), and peripheral vascular disease (PVD), is very frequent in the TAVI population, affecting around 30-70% of patients. In patients with CAD, the need to re-access the coronary arteries after TAVI is challenging and can be hampered by the trancatheter valve struts. This is critical in TAVI patients with an acute coronary syndrome and in younger patients with long-life expectancy after TAVI. The use of a P2Y12 inhibitor provides significant ischemic protection in the in the coronary, cerebral and peripheral vascular territories compare to Aspirin. The use of a P2Y12 inhibitor as antiplatelet treatment can decrease the need for new coronary revascularizations and reduce the incidence of thromboembolic complications after TAVI.

This is a prospective, multicenter, single-arm clinical investigation designed to evaluate the safety and performance of an investigational transcatheter aortic valve replacement system in patients with symptomatic severe native aortic valve stenosis who are considered appropriate candidates for transcatheter valve replacement. Eligible subjects will be enrolled at multiple investigational sites and followed according to the clinical investigation plan. The study will assess procedural success, device performance, and clinical safety using predefined clinical and echocardiographic outcome measures. Subjects will undergo scheduled follow-up evaluations to assess device performance, functional status, quality of life, and the occurrence of adverse clinical events over the study period.

Aortic Stenosis (AS) is the most common valvular pathology, particularly prevalent in advanced age, and Transcatheter Aortic Valve Implantation (TAVI) has become a crucial treatment option for high-risk patients who are not suitable for surgery. This minimally invasive approach has demonstrated successful clinical outcomes in patients deemed ineligible for surgical procedures. Patient selection criteria and advancements in operative techniques are critical for achieving successful TAVI outcomes. While the transfemoral approach is the most commonly used method, alternative techniques such as transapical, transaxillary, transcarotid, and transaortic approaches are also available. The Pericapsular Nerve Group Block (PENG) targets the femoral and accessory obturator nerves, providing analgesia to the anterior hip without causing motor block. The Fascia Iliaca Block (FIB), on the other hand, provides broader analgesic coverage by affecting the lateral femoral cutaneous, obturator, and femoral nerves. This study aims to compare PENG block, FIB, and local infiltration anesthesia in TAVI patients regarding sedation requirements during the procedure and postoperative analgesia management. Additionally, pain scores, motor block presence, opioid consumption, and side effects will be assessed. The study seeks to identify optimal strategies to enhance patient comfort and safety during TAVI procedures.

This study is a multicenter, retrospective registry study using the CHATEAU Registry. The study will evaluate patients who underwent transcatheter aortic valve replacement between January 2021 and December 2025. The purpose of the study is to assess clinical outcomes and valve performance after TAVR in real-world practice, with a focus on procedural strategies, valve-related factors, and long-term outcomes. Patient clinical information, imaging findings, procedural data, echocardiographic results, and follow-up outcomes will be collected from existing medical records. No additional intervention, treatment, or study-specific visit will be performed.

The goal of this trial is to to determine whether use of a novel SGLT2 inhibitor, Enavogliflozin 0.3 mg once daily is superior to placebo, when added to standard-of-care, in reducing the composite of major cardiovascular events and Heart Failure events (hospitalization for Heart Failure or urgent Heart Failure visit) among patients who underwent transcatheter aortic valve replacement for severe aortic stenosis and with heart failure with preserved ejection fraction.

Aortic valve stenosis is the most common valve disease leading to surgical or percutaneous intervention in Europe and North America. Percutaneous aortic valve replacement (TAVI) is currently recommended for the management of patients with symptomatic aortic stenosis and with high; very high operative risk of aortic valve replacement surgery or intermediate operative risk of aortic valve replacement surgery after a benefit-risk assessment by a heart team and operative contraindication to conventional aortic valve replacement surgery. These indications are supported by the 2017 European Cardiology guidelines. This technique of percutaneous arterial valve implantation is most often performed via the femoral route, under local anesthesia, with placement of a prosthetic biological valve in the aortic position, impacting it into the patient's native aortic valve. TAVI has been shown to be superior to medical treatment in patients with a aortic valve stenosis at very high operative risk of conventional aortic valve replacement surgery. However, the occurrence of atrioventricular conduction disorders (de novo left bundle branch block (LBBB) or complete AVB) remains the most frequent complication after TAVI. Therefore, the rate of pacemaker (PM) implantation after TAVI remains high, ranging from 2% to 51%, with an average rate of 13%. Pacemaker implantation has several deleterious effects (increased hospitalization time, desynchronization of the left ventricle by permanent right ventricular pacing, exposure of the patient to procedural complications of pacemaker placement, and possible increase in the final cost to society of the initial hospitalization. Not all patients who received a pacemaker post TAVI implantation use their PM. The rate of Pacemaker dependency and therefore of patients who actually use their pacemaker is approximately 33-36% at 1 year after percutaneous valve implantation. In view of all the potentially deleterious consequences of post TAVI pacemaker implantation, it is therefore necessary to know which patients really justify pacemaker implantation after percutaneous valve implantation. The purpose of this study is to investigate diagnostic imaging criteria that may be predictive of the occurrence of intramyocardial conduction disorders post TAVI implantation. Although some patients present only transient conductive disturbances, the impact of tissue inflammation of the intramyocardial conduction pathways after TAVI remains to be understood.

Both contrast-induced acute kidney injury (AKI) and pre-existing chronic kidney disease are associated with an increased mortality risk in patients requiring aortic valve replacement. Nonetheless, the direct haemodynamic impact of the aortic barrage (i.e. pre-renal mechanism) on renal function compromising and its reversibility in patients undergoing trans-catheter aortic valve implantation (TAVI) is unknown. This registry aims to evaluate the effect of severe aortic stenosis removal on the risk of contrast-induced acute renal injury (CI-AKI) during TAVI procedures and on renal function evolution

Transcatheter aortic valve implantation (TAVI) is an established treatment for severe aortic stenosis. Despite improved procedural outcomes, neurocognitive complications such as postoperative delirium (POD) and postoperative cognitive decline (POCD) remain clinically relevant. Heart Valve Units (HVU) are specialized interdisciplinary care structures designed to improve treatment pathways and healthcare quality. However, their impact on neuropsychological outcomes has not been sufficiently investigated. HVU-NEURO is a prospective observational cohort study evaluating neuropsychological outcomes before and after implementation of an HVU. Approximately 500 patients undergoing transcatheter valve therapy will be included. Neurocognitive function will be assessed before intervention, at hospital discharge, and three months after intervention. POD will be assessed using the Intensive Care Delirium Screening Checklist (ICDSC). The primary objective is to evaluate the effect of HVU implementation on postoperative cognitive decline at discharge from acute hospital care.