Clinical Research Directory

Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation

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.

Cardiovascular Acoustics for Early Disease Detection

There are many types of heart disease. Two of the most common causes are narrowings within the blood vessels that supply the heart (known as coronary artery disease), or valves within the heart becoming narrowed (stenosed) or leaky (regurgitation), known as heart valve disease. There are two main types of imaging used to test for these conditions. Coronary artery disease can be diagnosed by taking X-ray pictures of a dye when injected into the blood vessels. In some cases the dye is injected into the veins and a CT scanner is used (CT coronary angiography), in others the dye is injected via a tube placed in the artery (invasive coronary angiography). Valvular heart disease is normally diagnosed using an echocardiogram (ultrasound of the heart). In this study the investigators are looking for subtle changes in the sounds that come from the heart, which may allow heart disease to be detected earlier. The investigators are using a novel device, similar to a digital stethoscope, that has excellent sensitivity for heart sounds. Ultimately this may be used in community settings including GP surgeries, in this study the investigators are collecting sounds from patients undergoing routine scans as part of their workup for heart disease.

Evaluation of Valvular Heart Disease Using Cardiac CT

The EVIDENTIA Registry is a multicenter study designed to evaluate valvular heart disease (VHD) using cardiac CT. It aims to assess cardiac valve anatomy, function, and myocardial characteristics through detailed CT analysis. 1. Assessing the accuracy of cardiac CT in evaluating cardiac structure, volume, function, and myocardium in VHD patients. 2. Comparing the severity, classification, and etiology (primary vs. functional) of VHD. 3. Monitoring serial changes in VHD severity via echocardiography. 4. Investigating the relationship between echocardiographic and CT-derived parameters. 5. Examining the correlation between imaging findings, VHD interventions, and patient prognosis.

Echocardiographic Assessment of Valvular Dysfunction in Children With CHD

This cross-sectional study aims to assess the type and severity of valvular dysfunction by echocardiography in children with congenital heart disease.

Home-Based Cardiac Rehabilitation Using a Novel Mobile Health Exercise Regimen Following Transcatheter Heart Valve Interventions

The vast majority of cardiac rehabilitation eligible individuals do not participate in center based cardiac rehabilitation (CBCR). While steps to encourage participation in CBCR are important, many individuals will still not participate for a variety of reasons. This randomized controlled trial is evaluating a home-based cardiac rehabilitation (HBCR) intervention delivered using a custom app and digital tools in patients undergoing transcatheter heart valve interventions (THVIs). After a brief roll-in period, participants not intending to participate in CBCR are randomized to one of three groups: (1) control, (2) HBCR mobile health intervention with hands-off delivery, and (3) HBCR mobile health intervention with interactive delivery. Participants in the intervention groups (hands-off/interactive delivery) will also be randomized to continue the intervention for 12 weeks or 24 weeks. The intervention targets key health behaviors and includes traditional cardiac rehabilitation components. The study will assess the effect of the intervention on clinical events, physical activity, quality of life, and other outcomes. Those who intend to participate in CBCR will be followed in a registry.

Abbott Structural Heart Device Registry

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.

In Search of Best Practices for Patients With Heart Failure and Secondary Mitral Regurgitation: An Evaluation of the Inova Heart Failure Treatment Algorithm

The overarching goal of this research proposal is to study the feasibility and clinical impact of implementing an Inova system-wide heart failure treatment algorithm for patients with symptomatic heart failure due to reduced left ventricular ejection fraction (HFreF) and secondary MR Aim is to check the effectiveness of the IHFTA in identifying patients who are most likely to benefit from percutaneous transcatheter Mitraclip repair in real world

Longitudinal Validation of CIRC Technologies

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 the unique opportunity to form a more comprehensive understanding for various cardiovascular diseases. The study 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.

Prehabilitation for Patients Undergoing Elective Cardiac Surgery

The objective of this clinical trial is to develop a novel rehabilitation model that, through the PRECICA program, will help to reduce perioperative and postoperative complications in the care process prior to planned cardiac surgery. This will be achieved by reducing the total postoperative hospital stay and the physical and psychological complications resulting from surgery. The target population for this trial is patients undergoing planned cardiac surgery due to chronic coronary artery disease, valvular pathology, chronic thromboembolic pulmonary hypertension and/or aortic injury. Consequently, the quality of life of these patients could be enhanced.

Optimized Expansion of the Implanted Transcatheter Aortic Valve

Optimized Expansion of the implanted transcatheter aortic valve to reduce hypoattenuating leaflet thickening in non-atrial fibrillation patients undergoing transcatheter aortic valve implantation (TAVI): an international, multicentre, randomized controlled trial. The objective is to evaluate whether TAVI with systematic optimized pre- and post-dilatation (optimized expansion (OptEx) TAVI strategy), compared to a standard of care (SoC) TAVI strategy, is superior in reducing hypoattenuating leaflet thickening as evaluated by cardiac computed tomography (CT) imaging at three months after TAVI. The primary outcome is at least one thickened TAV leaflet involving ≥ 25% of the leaflet curvilinear dimension as assessed at cardiac CT at three months after TAVI.

A Study Of Clinical Implications Of Pulmonary Vascular Disease In Valvular Heart Disease

The purpose of this study is to characterize pulmonary hemodynamic profiles, with a focus on PVR subtypes, in patients with left-sided valvular heart disease undergoing aortic or mitral valve intervention, and to identify patterns predicting reversibility of TR and RV dysfunction.

Evaluation and Validation of Management Strategy for Conductive Disorders After TAVR (EVATAVI)

Considering decrease of major complications and improvement of procedural results, conductive disorders currently remain the main issue after TAVR (Transcatheter aortic valve replacement). While pacemaker implantation rate was about 10-15%, new onset LBBB (Left bundle branch block) was observed in 30 % of patients after TAVR but resolved at discharge in the majority of them, with less than 20% progressed to complete AV (atrioventricular) block requiring permanent pacing at hospital discharge. Higher implantation and improvement of the devices were associated with decline of pace maker implantation rate over the years in experienced teams. While guidelines do not give definite recommendation regarding conductive disorder management and pacemaker indication, a strategy of selective telemetry monitoring (TM) after TAVR according to the risk of conductive disorders may be proposed to limit indication and lenght of stay of intensive care unit admission (ICU), allowing direct admission of lower risk patients in general cardiology ward (GCW) without TM, to decrease the duration of TM when a conductive disorder is stable or regressive and finally to decrease the rate of pacemakers implantation. Potential benefit may also include limitation of ICU overload in high volume TAVR centers, investigators can also expect shorter hospitalization duration, with potential economic impact, in line with the development of algorithms for fast track procedures. Therefore the main objective of our prospective study was to evaluate feasibility and safety of a strategy of management of conductive disorders after TAVR based on an algorithm of diagnosis, monitoring and therapeutic strategies based on ECG analysis.

MULTIVALVE : A Prospective Multicentre Study of Multiple and Mixed Valvular Heart Disease

Multiple and mixed valvular heart disease (MMVD) is a common condition in clinical practice. It corresponds to a combination of stenotic or leaky lesions on two or more heart valves (multiple valve disease), or a combination of stenotic and leaky lesions on the same valve (mixed valve disease). However, the management of their clinical, biological and cardiovascular imaging is not well established. Current European Society of Cardiology (ESC) recommendations primarily address the various valve diseases in isolation. This results in an absence of reliable recommendations for managing MMVD, with different approaches being adopted by care centres. In order to address this knowledge gap regarding MMVD, it is crucial to assess its prevalence, the cardiovascular imaging methods employed and the management strategies, as well as to identify prognostic factors for the various combinations of valve disease. The multicentre MMVD study will be a valuable resource as it will improve our understanding of the prognosis for patients with MMVD. It will highlight imaging and biological markers associated with the prognosis of different combinations of MMVD.

AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Assessment Using COR ECG Wearable Monitor

This prospective, multicenter, cluster-randomized controlled study aims to evaluate the accuracy of an investigational artificial intelligence (AI) Software as a Medical Device (SaMD) designed to compute ejection fraction (EF) severity categories based on the American Society of Echocardiography's (ASE) 4-category scale. The software analyzes continuous ECG waveform data acquired by the FDA-cleared Peerbridge COR® ECG Wearable Monitor, an ambulatory patch device designed for use during daily activities. The AI software assists clinicians in cardiac evaluations by estimating EF severity, which reflects how well the heart pumps blood. In this study, EF severity determination will be made using 5-minute ECG recordings collected during a 15-minute resting period with participants seated upright. The results will be compared to EF severity obtained from an FDA-cleared, non-contrast transthoracic echocardiogram (TTE) predicate device. This comparison aims to validate the accuracy of the AI software.

Diagnostic Study of Structural Heart Disease Based on Cardiac Electromechanical Signals

Study participants will be prospectively recruited from consecutive outpatient and inpatient populations presenting to the Cardiology and Cardiac Surgery Departments of the following participating institutions: The First Affiliated Hospital of Xi'an Jiaotong University, The Second Affiliated Hospital of Xi'an Jiaotong University, and \[add additional participating institutions as applicable\].

Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study

ARB-PMCF is a multicenter, observational study of the safety and performance of Abbott annuloplasty devices used in surgical repair of mitral and tricuspid valve regurgitation. The devices included in this study are the SJM™ Rigid Saddle Ring and SJM Séguin Annuloplasty Ring, indicated for mitral valve repair, and the SJM Tailor™ Annuloplasty Ring and SJM Tailor Annuloplasty Band, indicated for mitral or tricuspid repair. Participants will be enrolled prior to undergoing mitral or tricuspid valve repair surgery including an Abbott annuloplasty implant and will complete annual follow-up visits through five years from implant. The study is being conducted to meet post-market clinical follow-up requirements of the European Union Medical Device Directives.

Development of CIRC Technologies

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.

Comparing Measurements of the Aortic Valve Taken During Surgery With Those Obtained Before Surgery Using Computed Tomography Scans, in Patients Undergoing Surgical Aortic Valve Replacement

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 ).

DELINEATE-Prospective

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.

PPG to Predict Ejection Fraction and Other Echographic Data in the General Population

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.

Echocardiographic Screening of Pregnant Women During Antenatal Care

Non-obstetrical drivers of adverse pregnancy outcomes are underappreciated. Latent structural heart disease may account for a substantial proportion of adverse pregnancy outcomes in low-resource settings. Pregnant women presenting to B.P. Koirala Institute of Health Sciences will be prospectively included into a registry upon their visit for antenatal care. Women will be followed until 6 weeks after the time of delivery. Nested within this registry, the investigators will perform a registry-based adaptive cluster randomized crossover trial. The trial compares an experimental condition (echocardiographic screening) and a control condition (routine antenatal care).

Comparison of Post-operation Cardiopulmonary Capacity of Patients Underwent Conventional and Robot-assisted Coronary Artery Bypass Graft and Valve Replacement Surgery

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.

Mechanism and Effect of Novel Metabolites on Valvular Heart Disease

Valvular heart disease (VHD) is a leading cause of loss of physical function, reduced quality of life and increased longevity.The epidemiology of VHD varies widely across the globe, with functional and degenerative diseases occurring predominantly in high-income countries and rheumatic heart disease occurring predominantly in low- and middle-income countries. The prevalence of valvular heart disease (VHD) is increasing globally due to improved survival and aging populations, poorly controlled by medications, with the majority of patients having to undergo surgical or interventional treatments. It is therefore important to search for novel metabolites and conduct mechanistic studies on the effects of these metabolites on patients with heart valve disease. In the Hestia study, the investigators looked for risk factors and mechanisms associated with the development and prognosis of VHD through long-term follow-up of VHD patients and metabolite testing of specimen tissues.

Screening of Valvular Heart Disease Using Single-channel Electrocardiogram

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.