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NCT07462260
Pulmonary hypertension secondary to left heart disease is associated with increased morbidity and mortality, particularly in patients with rheumatic chronic valvular heart disease, which remains highly prevalent in low- and middle-income countries. These patients often present late with severe pulmonary hypertension, limiting surgical options and worsening outcomes. Sildenafil, a phosphodiesterase-5 inhibitor, has demonstrated benefit in various forms of pulmonary hypertension; however, its role in pulmonary hypertension secondary to rheumatic valvular disease remains inadequately studied. This double-blind, placebo-controlled randomized clinical trial aims to evaluate the efficacy and safety of sildenafil as an adjunct to standard medical therapy in patients with severe pulmonary hypertension due to rheumatic chronic valvular heart disease. Eligible participants will be randomized in a 1:1 ratio to receive either sildenafil (25 mg three times daily) or placebo for six weeks. The primary outcome is change in six-minute walk distance, while secondary outcomes include changes in right ventricular function and dimensions, systolic pulmonary artery pressure, NYHA functional class, and hospitalization rates. The study seeks to generate evidence to support medical optimization and bridging therapy in this high-risk population awaiting definitive surgical intervention.
NCT07057466
This study aims to improve the early detection of undiagnosed heart disease, which causes serious health issues, hospital admissions, and high healthcare costs. Researchers are exploring how artificial intelligence (AI) can analyse routine heart tests, called electrocardiograms (ECGs), to detect heart problems. These tests can be done using both traditional ECG machines and portable, wearable devices like smartwatches, making it easier for people to monitor their heart health at home. While AI has shown promise using past data, this study will involve the collection of ECG data and subsequent testing of its accuracy in real-world settings to ensure it works well for both doctors and patients. The goal is to see if AI can identify conditions like heart muscle weakness, valve issues, and high lung pressure from the ECG data of patients. The researchers will also compare AI's detections with other blood tests commonly used to diagnose heart disease. The AI models that will be used are being tested for research and validation purposes only. They will not be used for clinical decision-making or providing information to influence diagnosis, treatment, or patient care during the study. The AI outputs are not shared with clinicians and will have no impact on the care pathway. This research will demonstrate if AI-powered ECG analysis - whether from traditional or portable devices - can provide a low-cost, non-invasive way to detect heart disease early and improve health assessments.
NCT04843371
The investigators are aiming to investigate the association between ejection fraction (EF) determined by echocardiography and signals obtained from Photoplethysmography (PPG) in the general population. The investigators are also aiming to investigate the association between blood pressure and signals obtained from PPG in the general population. Finally, the investigators are also aiming to investigate the association between signals obtained from PPG in the general population to cardioechographic findings such as, valvular heart disease, structural heart diseases, cardiomyopathies, pericardial disease etc.
NCT07379112
This study, called the EuroDafodil Registry, is being conducted to understand how safe and effective the Dafodil™ and Dafodil Neo™ Pericardial Bioprosthetic heart valves are when used in routine medical practice. The registry includes adult patients (18 years or older) who require surgical replacement of their aortic or mitral heart valve, either because their natural valve is severely diseased or because a previously implanted valve is no longer working properly. All patients in this registry will receive a Dafodil™ heart valve as part of their standard surgical treatment. No experimental procedures are involved beyond usual clinical care. This is a prospective, multi-centre registry being conducted at approximately 50 hospitals across Europe, with a planned enrollment of at least 500 patients. The study does not compare treatments; instead, it follows patients who receive the Dafodil™ valve to collect real-world information on outcomes. Doctors will monitor patients during their hospital stay and through regular follow-up visits at 1 or 3 months, 1 year, 3 years, and up to 5 years after surgery. Information collected includes survival, heart valve function, complications such as blood clots or infections, heart performance on echocardiography, and quality of life. Participation in this registry is voluntary. All patients must provide written informed consent before joining. Patient privacy will be protected: personal identifiers will not be shared, and data will be coded so individuals cannot be directly identified. The results of this registry will help doctors and health authorities better understand the long-term safety, performance, and durability of the Dafodil™ heart valves in real-world clinical use.
NCT06590467
The Abbott Structural Heart (SH) Registry is being conducted to confirm the safety and performance of Abbott's SH devices in a post-market, real-world setting. The Registry primarily involves gathering data from routine hospital practices and standard-of-care (SOC) procedures administered to patients. All devices used in these procedures must be commercially available to the participating site. A list of specific devices covered by the Registry are available upon request from the Sponsor. Data generated by the Registry will be used to meet regulatory requirements, such as the European Union Medical Device Regulations 2017/745, that require active post-market clinical follow-up (PMCF) for all commercially available devices.
NCT05330468
Regent China Post-Market Clinical Follow-Up (RC-PMCF): this clinical study is to confirm the safety and performance of Abbott's Regent MHV for replacement of native or prosthetic aortic valves in a Chinese population.
NCT05430568
Robotic surgery is one of the most popular minimally invasive procedures for patients with coronary artery disease or valvular diseases. Studies have shown that, as compared to conventional sternotomy, patients underwent robot-assisted bypass grafting or valvuloplasty had less post-operation pain, blood transfusion volume during operation, re-operation rate, post-operation stroke rate and length of hospitalization. However, most studies focused on the comparison of complications of different procedures, and the investigation of cardiopulmonary function recovery is still lacking. Thus our study is to compare the functional outcomes between patients that undergo different surgical procedures.
NCT07125469
This study aims to understand why there may be differences between the measurements of the aortic valve taken before and during surgery. Specifically, it will compare the valve size suggested by a CT scan (Computed Tomography) with the size measured during the operation using surgical tools. This will help determine which method is more accurate for selecting the right valve size in patients undergoing SAVR (Surgical Aortic Valve Replacement ).
NCT07099417
It is a prospective, controlled, single-center, observational, non-randomized study. The study is planned to include at least 1000 patients over 18 years old in the training sample and 200 patients over 18 years old in the test sample (the total number of patients is at least 1200 people). All patients will undergo an echocardiography examination with a comprehensive analysis of the function of the valves and other structures of the heart according to current recommendations by two independent experts. Registration of electrocardiogram will be performed immediately after echocardiography using a single lead ECG monitor (in I standard lead) for 1 minutes. The obtained data will be stored in the remote monitoring center of Sechenov University without being linked to the personal data of patients. A spectral analysis of the electrocardiogram will be performed using a continuous wavelet transform. The result of this study will be the identification of ECG parameters that will correlate with valvular heart disease.
NCT04618718
The PROTEMBO C Trial is an international, multi-center, single arm, non-inferiority study of the safety and performance of using the ProtEmbo System for cerebral embolic protection in subjects with severe native aortic valve stenosis indicated for TAVR.
NCT05654272
Cardiovascular disease is the leading cause of death worldwide. Advanced cardiovascular imaging using Magnetic Resonance Imaging (MRI) has proven to be effective in providing gold standard myocardial tissue characterization. Moreover, the intrinsic advantage of MRI's lack of exposure to ionizing radiation is particularly beneficial. At the same time, blood work can be very useful in early detection of certain cardiomyopathy, such as amyloid. However, there is a lack of agreement of on which markers are the most sensitive. This multi-study will allow us the unique opportunity to form a more comprehensive understanding for various cardiovascular diseases. Our team has developed novel cardiac MRI techniques that leverages endogenous tissue properties to reveal a milieu of deep tissue phenotypes including myocardial inflammation, fibrosis, metabolism, and microstructural defects. Among these phenotypes, myocardial microstructure has proven to be most sensitive to early myocardial tissue damage and is predictive of myocardial regeneration. In this study, the investigators aim to further study the importance of cardiac microstructure revealed by MRI in patient and healthy population and compare this novel technology with conventional clinical biomarkers.
NCT03488420
The objective of this registry is the characterization of patients with atrial fibrillation (AF) and/ or atrial flutter (AFL) with confirmed VHD who are prescribed edoxaban in a real life clinical setting.
NCT06634121
To investigate potential differences in procedural outcomes of both commercially available transcatheter edge-to-edge mitral valve repair devices in a non-selected clinical setting.
NCT05325723
This pilot study is to investigate the feasibility of obtaining medical grade audio phonocardiogram (PCG) recordings using a smartphone-based auscultation device in the first step. The ability to determine Valvular Heart Disease (VHD) (i.e., presence or absence of cardiac murmurs) using novel handheld CAA-devices shall be analyzed and first data on a smartphone-based auscultation in a hospital setting shall be collected. In further studies, the data provided from this study can be used to investigate the potential diagnostic use of such devices in the ambulatory and stationary care scenarios.
NCT05892588
This registry is a large-scale epidemiological study (PREVASC) aimed at estimating the prevalence of symptomatic and asymptomatic valvular hear disease in men and women aged over 65 years randomly selected in Italy.
NCT03541213
Iron is involved in essential functions of the body. It allows the transport of oxygen in the blood, via hemoglobin, at the muscular level, via myoglobin, and it is also involved in cellular metabolism in general, in particular for the production of ATP at the mitochondrial level, within the cytochromes and iron-sulfur proteins of the respiratory chain. Recently, iron deficiency has been identified as an important prognostic factor in heart failure patients. Iron therapy improves symptoms and physical performances of heart failure patients, even in the absence of anemia. As a result, the correction of iron deficiency is now proposed as one of the therapies for heart failure. However, the pathophysiology of the association between cardiac dysfunction and iron deficiency is still poorly understood. The investigators previously developed a mouse model of iron deficiency without anemia, in which the investigators observed impaired physical performances, a decrease of left ventricular ejection fraction, and a decrease in mitochondrial complex I activity. These abnormalities were normalized after iron injection. These animal data suggest that iron deficiency is responsible for left ventricular dysfunction secondary to mitochondrial I complex abnormalities, and that iron therapy corrects them. Iron deficiency is very common in the preoperative period of cardiac surgery, affecting 40 to 50% of patients. During this surgery, it is possible to perform a myocardial biopsy without risk to the patient. The purpose of this study is to verify in patients requiring valvular heart surgery, if iron deficiency is responsible for a decrease in mitochondrial complex I activity and a decrease in cardiac function during the perioperative period, and to verify whether iron treatment improves these abnormalities.
NCT05014750
Despite the rapid development of medical and nursing technology, the prognosis of valvular heart disease has been greatly improved. However, compared with young patients, the mortality and adverse event rate of elderly patients with valvular heart disease are still high, surgical complications are more frequent and hospitalization time is longer. The complexity of valvular heart disease and the poor prognosis in the elderly forces us to continue to look for other potential prognostic factors. In addition to the adverse outcomes caused by disease factors, elderly patients with valvular heart disease also have the gradual decline of physiological and psychological reserve function caused by age factors. These adverse outcomes include osteopenia, disability, prolonged hospitalization and even death are all closely related to frailty. Frailty is 'a biologic syndrome of decreased reserve and resistance to stressors, resulting from cumulative declines across multiple physiologic systems, and causing vulnerability to adverse outcomes. The essence of frailty is the decline of individual resistance, which eventually leads to the increase of individual brittleness and susceptibility to adverse health outcomes. At present, the research in the field of elderly vulnerable groups of cardiovascular disease in China started late, mostly focusing on the study of pathological mechanism, the introduction of evaluation tools, conceptual analysis and so on. Almost all of the existing studies are about the debilitation status of elderly patients with heart valve disease, and most of them mainly try to find the influencing factors of debilitation from the aspects of patients' physical diseases, ignoring the impact of factors such as the mental health status of the elderly on debilitation, there are few reports of short-term adverse events in elderly patients with valvular heart disease. This study will analyze the influencing factors of the weakness of elderly patients with valvular diseases from the multi-dimensional aspects of demographic data, physical diseases, psychology and society, and track the short-term prognosis of patients with death, fall and unconventional rehospitalization, so as to provide a research basis for relevant research in the future.
NCT04877795
In-hospital mortality after cardiac surgery ranges from 2-6%. Many patients suffer from major adverse cardiovascular events (MACE) which results in impaired disability-free survival. Troponin plays the central role in identifying MACE. However, interpretation after cardiac surgery is difficult due to ischemia-reperfusion-injury and direct surgical trauma. While the 4th universal definition of type 5 myocardial infarction uses the 10 x ULN as cut-off, \>90% of patients after on-pump procedures exceed this cut-off. Clinical consequences are unclear. The dynamic of Copeptin and Heart-type fatty acid binding protein (H-FABP) concentrations starts very early, i.e. several hours before Troponin. The investigators plan a prospective multicenter cohort study to evaluate 1) the independent association between Copeptin and H-FABP with disability -free survival and MACE after cardiac surgery; 2) the predictive gain of their addition to the Euroscore II; 3) the independent association between H-FABP and acute kidney injury.
NCT04632914
PURPOSE: The aim of this study is to investigate the effect of trunk stabilizing exercises on sternal instability in patients with median sternotomy after heart valve surgery
NCT04301648
The hypothesis is that patients with structural heart disease who are treated by STructural heARt nurses obtain better results in indicators of quality of care, compared with the usual practice (or not assisted) by this type of new interventional cardiology's nursing role.