Clinical Research Directory

Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients

Hospital-at-Home (H@H) programs provide hospital-level acute care in the patient's home and may reduce healthcare utilization while improving patient experience. Although H@H models have been evaluated in several acute medical populations, evidence regarding their safety and efficacy in a broad population of patients with acute cardiovascular conditions remains limited. HeaRt@Home is a prospective, randomized controlled trial designed to evaluate the safety and efficacy of H@H compared with standard in-hospital care in clinically stable cardiac patients admitted to Tel Aviv Sourasky Medical Center. The study will enroll 150 adults hospitalized for selected cardiovascular conditions, including acute myocardial infarction following uncomplicated percutaneous coronary intervention, pericarditis or myocarditis, pulmonary embolism, post transcatheter valvular intervention, acute or worsening heart failure, or following Pacemaker or Implantable Cardioverter-Defibrillator Implantation. Eligible patients will be assessed within the first 12-24 hours following clinical intervention and randomized to either continued standard hospitalization or H@H care. Patients assigned to H@H will receive hospital-level care at home, including continuous remote monitoring of vital signs and cardiac rhythm, 24/7 access to the hospital monitoring center, at least one daily home visit by a nurse, and at least one daily virtual assessment by a cardiologist. Laboratory testing, imaging, oral and intravenous medications, oxygen therapy, and additional specialist consultations will be provided at home as clinically indicated. A predefined emergency pathway will enable rapid transfer back to the hospital when required. The study will assess safety outcomes including all-cause mortality, hospital-acquired infections, hemodynamic deterioration, acute kidney injury, venous thromboembolism, medication errors, 30-day readmission, and 30-day mortality. Patient experience will be evaluated using the 15-item Picker Patient Experience Questionnaire. Secondary outcomes will include length of stay, healthcare resource utilization, mobility and physical activity, sleep, arrhythmias, need for escalation to hospital care, and psychological outcomes. The study aims to determine whether a structured, technology-supported H@H model can provide safe and effective hospital-level care for appropriately selected cardiovascular patients while potentially improving patient experience and optimizing healthcare resource utilization.

Robotic Transjugular Transcatheter Tricuspid Valve Replacement

Valvular heart disease (VHD), caused by abnormalities in heart valves, can lead to severe complications such as heart failure and death, with approximately 220 million affected patients worldwide. The prevalence of VHD continues to grow alongside the aging global population. Transcatheter heart valve interventions have emerged as minimally invasive alternatives, offering benefits like shorter recovery times and reduced discomfort. However, current manual catheter-based techniques are complex, highly dependent on clinicians' expertise, and involve significant physical risk due to prolonged exposure to X-ray radiation and cumbersome protective gear. To address these challenges, a novel, universal intracardiac robotic system is proposed to improve precision, safety, and procedural efficiency. This system integrates a high-dexterity, load-capacity catheter instrument, a modular concentric robotic platform, and an augmented reality (AR) navigation interface. The catheter's design balances flexibility for navigating complex intracardiac paths with the rigidity needed for device deployment. The robotic platform's modular architecture enhances versatility, enabling control across various procedures and anatomical variations, while the AR system facilitates intuitive preoperative planning and real-time intraoperative guidance through multimodal image fusion. The core innovation lies in overcoming existing limitations: balancing catheter flexibility and load capacity, expanding robotic system adaptability for different valve procedures, and improving integration with imaging modalities like computed tomography, transesophageal echocardiogram, and fluoroscopy. The project aims to develop sophisticated models for instrument design, control strategies for multi-instrument coordination, and advanced navigation tools. These technological advancements are intended to elevate the clinical utility of robotic intracardiac interventions, making them safer, more efficient, and easier to adopt widely. By establishing a systematic approach for intelligent, multimodal, robotic-assisted valvular procedures, this work promises significant contributions to minimally invasive cardiology and holds substantial potential for clinical translation.

Abbott Cephea Mitral Valve Disease Registry

The objective of this registry is to gather clinical data on symptomatic patients with mitral valve disease, including patients with mitral regurgitation, mitral stenosis, and mixed mitral valve disease. Data collected from this registry are expected to improve our understanding of the impact of correcting symptomatic mitral valve disease on clinical outcomes in patients that could be candidates for Transcatheter Mitral Valve Replacement and may also inform future regulatory or reimbursement submission strategies for the Cephea Mitral Valve System.

Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease

The objective of this study is to evaluate and predict the progression of moderate cardiac valve stenosis and regurgitation using clinical, biological, echocardiographic, computed tomography (CT), and magnetic resonance imaging (MRI) data. Additionally, the study aims to analyze the potential impact of device-based interventions, pharmacological therapy, and lifestyle modifications on disease progression.