Aortic Stenosis

Researchers are evaluating a new 10-minute cardiovascular magnetic resonance CMR imaging protocol designed to improve current CMR procedures for patients with various heart conditions, including coronary artery disease, cardiomyopathies, and other cardiac diseases. The study aims to develop a standardized, contrast-free imaging method that can be applied to about 70% of cardiac patients. The goal is to assess whether this shorter protocol enhances diagnostic decision-making and reduces healthcare costs. The study involves two groups healthy volunteers over 18 years old without significant cardiovascular or respiratory conditions, and patients over 18 years who require a clinically indicated CMR exam. The new protocol focuses on heart function and tissue characterization without using contrast agents. Researchers will compare the new 10-minute protocol to standard CMR imaging, evaluating its clinical feasibility, performance, and cost-effectiveness in different patient populations. Participants will undergo CMR scans using both the new and standard protocols. Researchers will monitor diagnostic results, scan completion rates, scan sequence times, adverse events, and cost differences between methods. Various heart tissue measurements and reproducibility between different readers and scanners will also be assessed. The study spans from 2019 to 2025, with ongoing safety monitoring during imaging sequences and a focus on improving the efficiency and quality of cardiac imaging.

This research aims to evaluate the use of two advanced transcatheter aortic valve implantation TAVI devices, JenaValve and J-Valve, for patients with pure aortic regurgitation AR. AR patients, who often face high risks with open heart surgery, have different heart flow and structure compared to those with aortic stenosis. The study focuses on understanding the unique challenges and follow-up needs, including the potential for leaflet thrombosis, in patients treated with these dedicated TAVI devices. Participants in this observational study receive TAVI treatment using either the JenaValve or J-Valve systems. These devices have special anchoring mechanisms designed for pure AR cases. The study involves detailed imaging assessments, including magnetic resonance imaging MRI and computed tomography CT, performed at baseline, within one month after the procedure, and during follow-up periods at six months and one year. Echocardiographic evaluations and clinical event tracking are also conducted immediately after, and up to 12 months post-procedure. Throughout the study, participants undergo extensive monitoring with various imaging tests to detect leaflet thrombosis and assess heart function over time. Researchers will review cardiovascular events like stroke, heart attacks, and hospitalizations for heart failure. Patient symptoms and functional status will be evaluated at multiple time points up to one year. The study provides careful observation of device performance and patient outcomes over a prolonged period, lasting until September 2028.

Researchers are evaluating the effects of transcatheter aortic valve implantation TAVI on patients with severe degenerative aortic stenosis, a condition where the hearts aortic valve narrows and affects blood flow. The study also includes a control group of patients with aortic stenosis who have not undergone valve replacement. The goal is to measure changes in heart tissue and function by comparing those treated with TAVI to patients receiving only medication. Participants will be divided into two groups one group will undergo TAVI following standard clinical procedures along with optimal medication therapy, while the control group will receive only optimal medication treatment. The recommended medications include several categories such as SGLT2 inhibitors, angiotensin receptor-neprilysin inhibitors, beta-blockers, mineralocorticoid receptor antagonists, and individualized diuretics. Each participant will have a special PETCT scan using the FAPI tracer at the start of the study and again six months later to assess heart tissue changes. Throughout the study, enrolled patients will be monitored with FAPI-PET scans to measure myocardial uptake values at baseline and six months after treatment or enrollment. The study will track the activity of heart fibroblasts, structural remodeling of the heart muscle, and changes in cardiac function. Participants are followed for at least six months to evaluate these outcomes, with all clinical and imaging assessments designed to compare the effects of TAVI and medication-only therapy on heart health.

Researchers are conducting a prospective, randomized, controlled, international study involving up to 1054 adults with severe native calcific aortic stenosis who need Transcatheter Aortic Valve Replacement TAVR. The trial aims to compare the DurAVR4 THV System with commercially available Transcatheter Heart Valves from the SAPIEN or Evolut series. Additionally, up to 446 low-risk subjects will be enrolled in a continued access cohort, and a separate registry will follow 150 subjects with failed surgical bioprosthetic valves requiring valve-in-valve TAVR using the DurAVR4 THV. Participants will be randomized to receive either the DurAVR4 THV System or a commercially approved SAPIEN or Evolut THV device for native aortic stenosis. Those in the valve-in-valve registry cohort will receive only the DurAVR4 THV. Subjects will be followed for up to 10 years in the randomized cohorts and 5 years in the valve-in-valve registry. The study involves device implantation through TAVR procedures performed under clinical guidelines. During the study, participants will be monitored for outcomes including a composite of all-cause mortality, stroke, and cardiovascular hospitalization after one year. Secondary measures include mortality, disabling stroke, bleeding, vascular complications, and acute kidney injury within 30 days post-procedure. Follow-up visits and assessments will track participant health and device performance over the long term to evaluate safety and effectiveness.

Researchers are evaluating a predictive tool called the Multifactorial Dynamic Perfusion Index MDPI to estimate the risk of acute kidney injury after cardiac surgery involving cardiopulmonary bypass CPB. This observational study involves adults and infants undergoing cardiac surgery, aiming to validate the MDPI in adults, develop a version for infants under 20 kg, and explore if the MDPI can predict other complications including mortality. The MDPI combines seven variables measured during CPB, many of which can be modified by the surgical team to potentially improve patient outcomes. The study is divided into three parts first, validating the MDPI in 800 adult cardiac surgery patients from two centers using existing CPB monitors that collect data such as hematocrit, oxygen delivery, arterial pressure, and transfusions second, developing a modified MDPI for 200 infants under 20 kg undergoing congenital heart surgery with additional infant-specific variables and third, investigating whether the MDPI can predict other postoperative issues like low cardiac output, longer ICU stays, bleeding complications, and 30-day mortality. Data collection includes parameters recorded during surgery and postoperative creatinine values. Participants will undergo cardiac surgery with CPB, during which relevant physiological data will be continuously recorded by specialized monitors. After surgery, kidney function and other outcomes will be monitored for up to 48 hours, with extended follow-up for complications and mortality over 30 days. Researchers will analyze how well the MDPI predicts acute kidney injury and other clinical outcomes, aiming to incorporate the MDPI into real-time monitoring devices to guide therapeutic decisions during surgery.

This trial studies adults aged 50 to under 80 with mild or moderate calcific aortic valve stenosis and elevated lipoproteina levels. Researchers are assessing the safety, tolerability, and ability of pelacarsen TQJ230 given once monthly by injection to slow the progression of this heart valve condition. The study compares pelacarsen to a placebo in a randomized, double-blind design. Participants receive either pelacarsen 80 mg or a matching placebo as a subcutaneous injection monthly. They continue treatment and monitoring for up to 36 months to observe changes in heart valve narrowing and calcium buildup. The study also tracks lipoproteina levels and clinical heart-related events during this period. Throughout the study, participants will have regular assessments including imaging to measure aortic valve function and calcium score, blood tests for lipoproteina, and monitoring for safety. The main outcomes analyzed after 36 months include changes in valve jet velocity and calcium score, alongside clinical events. Participants remain under medical care while being observed for any effects of the study drug or placebo.

Researchers are evaluating the safety and effectiveness of a transcatheter aortic valve system for patients with severe aortic stenosis, a serious heart valve condition. This prospective, multicenter, single-arm clinical trial plans to enroll 120 patients aged 70 years or older who have been diagnosed with symptomatic severe aortic stenosis and are not suitable candidates for conventional surgery. The trial aims to measure all-cause mortality within 12 months after the valve implantation as the primary outcome. Participants will receive the transcatheter aortic valve replacement using the Silara SR Heart Valve System. The study involves a single treatment group where all patients undergo this procedure. After implantation, patients will be closely monitored at several time points including immediately post-operation, at 7 days or discharge, 30 days, 6 months, 12 months, and annually up to 5 years. These visits will assess valve function, procedural success, device performance, improvements in cardiac function and quality of life, and any complications. During the study, patients will have regular clinical follow-ups involving imaging tests such as ultrasound, laboratory tests, and safety evaluations to monitor heart valve performance and overall health. Researchers will collect detailed clinical data to analyze device success, cardiac function improvements, mortality rates, and major adverse events up to five years post-procedure. The total participation time includes follow-ups up to 5 years to evaluate long-term safety and effectiveness of the valve system.

Researchers are evaluating the long-term safety and effectiveness of the NOVA intracranial drug-eluting stent system in patients with intracranial atherosclerotic stenosis. This study is a prospective, multi-center, single-arm clinical trial conducted across about 50 centers in China, aiming to include 1000 participants who are suitable candidates for stent angioplasty. The trial will run from December 2022 to December 2030, focusing on patients with significant artery narrowing in the brain. All participants will receive the NOVA drug-eluting stent, which is designed to treat intracranial artery stenosis with a sirolimus-eluting coating and a rapid exchangeable balloon. The study includes ten visits starting from preoperative screening, the operation day, then follow-ups at 30 days, 3 months, 6 months, 1 year, and annually up to 5 years after the procedure. This schedule allows researchers to closely monitor the devices performance and patient outcomes over time. Participants will undergo various assessments during these visits, including evaluations for stroke, death, ischemic events, and revascularization related to the treated artery. Other measures include rates of stroke in different brain regions, transient ischemic attacks, restenosis, bleeding events, and quality of life assessments using tools like the modified Rankin Scale and EuroQol-5D. Safety, device defects, and long-term outcomes will be carefully tracked throughout the study period, which lasts up to five years after the operation.

Researchers are observing patients who have undergone transcatheter heart valve procedures, including TAVI for aortic stenosis, valve-in-valve treatments, TAVI for aortic insufficiency, and TMVR for degenerated mitral valves. This study aims to track the real-world safety and effectiveness of these procedures over five years, focusing mainly on all-cause mortality from the initial treatment. It is a registry study conducted at Fondazione IRCCS Policlinico San Matteo in Pavia, Italy, enrolling adults over 18 years old. The study does not involve experimental treatments but collects routine clinical data through a secure electronic system. It monitors patients who have received transcatheter treatments using bioprosthetic valves on native aortic valves, failed aortic bioprostheses, or degenerated mitral prostheses or rings. Follow-up assessments are ideally scheduled at 3 and 12 months after the procedure, then annually, often by phone for stable patients. The study plans to enroll over 500 participants. Participants data are collected during their routine clinical visits, with follow-ups guided by their doctors. Researchers assess multiple outcomes including mortality, hospitalizations for heart failure, heart attacks, strokes, major cardiac events, valve function, complication rates, and inflammation markers over five years. The total participation duration varies, and the study aims to provide comprehensive long-term information on these heart valve procedures safety and performance.

Researchers are evaluating the effects of the ABC Bicuspid Sizing Algorithm on patients with bicuspid aortic stenosis undergoing transcatheter aortic valve replacement TAVR using the Sapien 3 valve. This international, multi-center study aims to determine if the algorithm improves technical success immediately after the procedure and device success 30 days later. The study also examines how additional imaging techniques like gated computed tomography and artificial intelligence-based simulations influence treatment decisions. The study involves about 290 patients eligible for TAVR or surgical aortic valve replacement SAVR. Physicians use the ABC Bicuspid Sizing Algorithm to guide treatment allocation between TAVR and SAVR, as well as valve sizing and deployment for those receiving TAVR. Some patients may have further evaluation with gated CT or AI simulations to assess risks. Data for TAVR patients is collected at baseline, during the procedure, at hospital discharge, 30 days after, and annually up to 5 years. SAVR patients have data collected at baseline and during the procedure only. Participants will undergo diagnostic imaging including CT scans evaluated with the sizing algorithm and may receive additional assessments if indicated. Researchers collect data on procedure success, device outcomes, conduction disturbances, pacemaker implants, stroke, vascular complications, mortality, valve function, and hospitalizations for heart failure over 5 years. Follow-up visits occur at 30 days and annually, allowing long-term monitoring of outcomes after treatment.