LVAD

This multi-center, prospective, randomized, double-blinded, placebo-controlled study aims to investigate whether withdrawal of aspirin from the antithrombotic regimen in patients supported with the CH-VAD pump is non-inferior to the standard antithrombotic regimen of vitamin K antagonist combined with aspirin in terms of safety and efficacy.

Current international guidelines recommend that patients with a heart pump (left ventricular assist device, LVAD) participate in supervised exercise cardiac rehabilitation programs. However, not all patients with a heart pump are able to attend to a supervised program on a daily basis. The goal of this clinical trial is to determine whether a home-based exercise program helps patients with a heart pump improve their exercise capacity and quality of life, guided by telemedicine tools including a mobile app, smartwatch, and remote medical checkups. The study will also provide information about the safety of this program by monitoring for any issues or symptoms during home activity. The trial aims to answer the following questions: * Does a 12-week remote exercise program improve patients' exercise capacity? This will be measured using the 6-minute walk test and a cardiopulmonary exercise test. * Is it safe for patients to follow this exercise plan at home while being monitored through a mobile app and smartwatch? * Does the program improve quality of life and reduce feelings of anxiety or depression? This will be assessed using widely validated questionnaires, such as the Kansas City Cardiomyopathy Questionnaire. Researchers will compare the remote exercise program to standard care, which usually does not include exercise for patients who are unable to attend the hospital daily. Participants will: * Join the study voluntarily after signing a consent form. * Be randomly assigned, with a 50% chance of being in either the exercise group (following a structured plan with a mobile app) or the usual care group (receiving general written advice), to see which approach works best for recovery. * Follow a 12-week home-based routine if in the exercise group, including warm-up routine, walking or cycling, respiratory exercises, and light strength training, all supported by the mobile app, smartwatch, and professional monitoring. * Visit the hospital three times over six months for medical checkups, including walking and exercise tests, blood analyses, and questionnaires about physical and emotional health.

All patients undergoing an implantation of a durable left ventricular assist device and monitored by pulmonary artery catheter showing no adverse events after surgery are included in the study and ventilated for 15 minutes using extra thoracic negative pressure ventilation and usual intrathoracic positive pressure ventilation. Hemodynamics changes between both ventilation modes, especially focussing on right ventricular function and measured by a pulmonary artery catheter, are compared.

Durable left ventricular assist devices (dLVAD) have been increasingly utilized since the mid to late 1990s, with an uptick of utility starting in 2010 following expanded indications for therapy to not only include a bridge to transplantation strategy, but also for those individuals who suffer from advanced heart failure (HF) and do not qualify for cardiac transplantation. Despite the decreasing size of the newest generation devices leading to a lessened occurrence of adverse events, bleeding and infection still remain a concern for clinicians, as well as a general lack of predictability towards adverse events in individuals with a dLVAD in place. There is a lack of description in the literature currently, regarding the interface between what the pump data provides and what is seen in clinical practice. There also is little known about the effects of what is provided in the pump data, in correlation to quality-of-life following dLVAD implantation. Therefore, the purpose of this study is to prospectively analyze normal and abnormal pump data through pump operations such as suction events, low flow alarms as well as other adventitious alarms, PI events and power cable disconnects greater than 20 seconds, from the HeartMate 3 ® dLVAD in order to clinically correlate this data to quality of life, frailty and other various medical conditions and adverse events as defined by the Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs). This will be achieved through two aims: 1) Evaluate the effectiveness of dLVAD pump operations data on clinical practice application (quality of life, frailty and various medical conditions, and adverse events such as GIB, RHF, infection, hypertension, arrhythmias and stroke); and 2) Evaluate correlations and relationships of longitudinal normal and abnormal dLVAD pump operations data, to demographic and clinical variables. This study is the first study to evaluate HeartMate 3 ® dLVAD pump operations data over time for effectiveness in the clinical practice.

This is a 22-subject prospective, multicenter, single-arm clinical trial to evaluate the safety and effectiveness of the Jarvik 2015 left ventricular assist device (LVAD) as a bridge to heart transplant in children weighing 8 to 30 kilograms. Data generated from the study will be used to support FDA review and potential approval of the device under the Humanitarian Device Exemption (HDE) regulation, the FDA approval pathway for devices intended to treat rare and orphan diseases.