The PK Papyrus Covered Coronary Stent System is a Humanitarian Use device (HUD) approved for the use of acute perforation in native coronary vessels or coronary bypass grafts in vessels 2.4-5.0mm in diameter. In an emergency situation, PK Papyrus may be used emergently outside its' approved indications if a patient has a life threatening condition that needs immediate treatment and no generally acceptable alternative treatment for the condition exists.
This study will compare WATCHMAN FLXTM ("DEVICE") to a category of OAC called non-vitamin K antagonist oral anticoagulation, also known as NOACs ("CONTROL"). NOAC medications include Pradaxa® (dabigatran), Eliquis® (apixaban), Xarelto® (rivaroxaban), or Savaysa® (edoxaban).The study will research the safety and effectiveness of the WATCHMAN FLXTM device compared to treatment with NOAC therapy to determine if it works for patients with your type of atrial fibrillation who require treatment for potential blood clot formation (thrombus) in the LAA.
The purpose of this study is to evaluate the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System in a patient population with symptomatic severe Aortic regurgitation ( a condition where the heart's aortic valve does not close tightly and allows some blood to leak back into the heart chamber) requiring replacement/repair of their native aortic valve that are at high risk for open surgical aortic valve replacement/repair (SAVR).
Your involvement in this study will last approximately 5 years from the time of your procedure. The visits include: Screening/Baseline, Procedure, Pre-Discharge, 1 month, 6 months and annualy for 5 years
Patients with cardiovascular disease (CVD) are at increased risk of depression following hospital discharge. Unfortunately, most depressed CVD patients do not receive appropriate care for their depression, often because they are unable to, or are fearful of traveling to providers for the regimen of 8-12 weekly visits of therapy such as Behavioral Activation (BA). This study will compare the effectiveness of BA for depression, delivered via Telehealth, to standard post-CVD hospital discharge best practices. It is predicted that patients who receive BA will have better mental health outcomes and will be less likely to be re-hospitalized compared to patients who receive standard post-discharge care.
Underserved, racial and ethnic minority communities are experiencing higher rates of COVID-19 cases and associated mortality compared to whites due to long standing social and structural inequities that also drive disparities in chronic diseases such as stroke, cardiovascular disease, diabetes, and hypertension. Patients with underlying chronic diseases who are recovering from COVID-19 depend on the support of family and friends (informal caregivers/care partners) who are being exposed to the same pandemic and racial stressors, exposure that can affect the health and quality of life of both partners. The primary goal of this study is to test the efficacy of an adapted, telehealth-enhanced intervention that targets barriers impacting family illness management behaviors of Black/African American (AA) adult COVID-19 survivors and carepartner dyads for improved quality of life and COVID/chronic illness health related outcomes.
The Advanced Cardiac Therapies Improving Outcomes Network (ACTION) is a distributed network-based learning health system (LHS) of care centers, clinicians, researchers and industry representatives partnering with patients who have heart failure and their caregivers with the ultimate aim of achieving health, longevity and quality of life equivalent to the general population. See https://www.actionlearningnetwork.org for more information. The initial focus will be to apply structured quality improvement methods, advanced information technology systems, and sharing of best practices to track and continuously improve health-related outcomes for children with heart failure requiring advanced therapies. In the future, we plan to collaborate with other established registries and learning network (i.e. UNOS, PHTS and Cardiac Networks United) to create an integrated network that improves care throughout all phases of a patient's illness including chronic heart failure, acute decompensated heart failure, ventricular assist device support and transplant.
This research study aims to determine a less invasive way to assess heart function by taking measurements of the heart while subjects are performing an exercise cardiac MRI. Subjects will undergo two exercise phases and MRI measurements will be taken after each exercise phase. These measurements will be compared to available clinical data (including demographic, hemodynamic, radiologic, and functional) and future outcome data.
This study is being done to evaluate the impact that monitored anesthetic care (MAC) versus general endotracheal anesthesia (GETA) has on hospital length of stay, rate of ICU admission, or procedural mortality. Also, we hope to determine if the use of Transesophageal Echocardiography (TEE) during GETA impacts device success and durability. Adult patients undergoing transfemoral approach TAVR for aortic valve stenosis may be eligible candidates for this study.
Elevated pressures in the heart can represent a severe medical condition known as pulmonary hypertension. This can result in chronic right heart failure. An abnormal increase in this pressure during exercise may be represent an early stage of vascular lung disease. This study will investigate the prognostic implications of the measured pressures obtained during exercise while undergoing a right heart catheterization procedure based on a large scale multi-center approach by using retrospective and prospective analysis of hemodynamic data.
The purpose of the study is to generate a bio bank of specimens for research. We will tissue that would otherwise be discarded from clinical or surgical procedure and information from medical records. We will also collect discarded blood, urines and sputum. Collecting samples will help to better understanding the mechanisms of cardiovascular diseases, identify biomarkers for early diagnosis and to predict safety and efficacy of new therapies.