The purpose of this study is to collect information about the safety and performance of the investigational leads ACUITY X4 and RELIANCE 4-FRONT. Patients who have been determined to require a Cardiac Resynchronization Therapy Defibrillator (CRT-D) to treat their heart condition will be eligible to be implanted with one or more investigational leads. The…
This research study is for patients with severe aortic stenosis. Patients may be considered for this study if they have a diseased aortic heart valve and who are at low operative risk for standard (traditional) open-heart surgery for aortic valve replacement (TAVR).
In this study, patients with heart failure, will undergo a cardiac catheterization procedure which either includes injections of stem cells from healthy young adults into the heart or a sham (mock) procedure that does not include injection of the stem cells. This is a study of an experimental product called rexlemestrocel-L.
The purpose of this study is to find out more about the effectiveness (how well the drug works), safety, and tolerability of an investigational drug called nivolumab (also known as BMS-936558) when given alone or when combined with ipilimumab in children/ adolescents/ young adults with high grade primary central nervous system (CNS) malignancies (certain…
This study is for children with relapsed or refractory acute myeloid leukemia (rrAML). Acute myeloid leukemia is a fast growing cancer of the blood and bone marrow. This study examines the effects of study drug Lenalidomide on children with rrAML. Lenalidomide is an anti-cancer drug that belongs to a group of drugs known as immunomodulating drugs (IMiDs), a…
The purpose of this study is to see if study drug GS-6615 improves the symptoms of Hypertrophic Cardiomyopathy (HCM) and helps the heart work better. HCM is a disease that affects the muscle of the heart. HCM is a condition in which the heart muscle becomes abnormally thick for no clear reason. This can make it harder for blood to enter and leave the heart…
Epstein-Barr Virus (EBV) is the virus that causes mononucleosis, also known as mono. Almost all adults have had EBV. For most people, EBV never causes a health problem. However, when their immune system is not working properly (people who have had a transplant and those who have immune disorders), EBV can cause certain diseases where cells grow abnormally.…
This study has been designed to treat patient with coronary artery disease and demonstrate the superiority of the OCT device used to select and guide the stenting procedure when collecting images and flow measures inside the blocked artery.
The purpose of this clinical investigation is to collect human clinical data in order to demonstrate thatthe EDWARDS INTUITY Valve System, EDWARDS INTUITY Aortic Valve, Model 8300ACA/ACD issafe and works properly as an aortic valve replacement and that the EDWARDS INTUITY ValveSystem, EDWARDS INTUITY Delivery System, Model 8300DCA/DCD is safe and works…
The overall purpose of this research is to treat diseases that are not cancer but are improved by bone marrow transplantation with mild and safer chemotherapy as pretransplant conditioning. This treatment is chosen because it is milder and is likely to have fewer long and short term side effects unlike older chemotherapy and radiation treatments. Yet, it…
This study is looking to compare the regular dose flu shot to a high dose flu shot, in patients who have had a heart attack in the past year, or have been in the hospital for heart failure in the past 2 years. All subjects enrolled will receive a flu shot and will be closely monitored by the study team.
The primary objective of this randomized controlled clinical trial is to evaluate the clinical efficacy and safety of the IASD System II in symptomatic heart failure patients with an LV ejection fraction 40%, and elevated left sided filling pressures despite standard Guideline Directed Medical Therapy (GDMT).
This observational study is designed to collect and evaluate information describing patients undergoingTAVR using two different clinical pathways. Information describing both groups will be analyzed tocompare safety and clinical outcomes. A quality of life and cost analysis will be performed to comparepatients in the Vancouver 3M Clinical Pathway with those…
This is a Phase 1 multicenter study of a drug called ABI-009 (nab-Rapamycin) in combination withtemozolomide and irinotecan in children and young adults with solid tumors (including CNS tumors)which have come back or have not responded to standard therapy. The study is considered experimental because ABI-009 (nab-Rapamycin) is not approved by the United…
The purpose of this study is to determine the effectiveness and safety of the study drug moxetumomab pasudotox in treating children with relapsed or refractory pALL or Lymphoblastic Lymphoma of B-cell origin. Moxetumomab pasudotox is made up of two parts: 1) a modified mouse antibody that attaches to a protein from the immune system, called CD22, which can…
The purpose of this study is to compare the safety and effectiveness of an approved medical device (OCT) which will be used to help select and guide the stenting procedure by collecting images and flow measurements inside the blocked arteries in comparison to both standard angiography and another medical device (IVUS). Coronary Artery Disease is the…
This is a phase I, multicenter, dose escalation study of MK-1775 in combination with radiation. The study treatment is considered experimental because it is not approved by the United States (US) Food and Drug Administration (FDA) for treating children and young adults with newly diagnosed Diffuse Intrinsic Pontine Glioma (DIPG). MK-1775 is an oral…
This study has been designed to treat patients with a pulmonary conduit or valve that has a large amount of regurgitation or is too narrow and needs to be replaced.
Are you scheduled for an interventional vascular procedure (e.g. BAV, TAVR/TAVI, EVAR or TEVAR) inorder to replace a damaged or failing valve? This research style studies the safety and efficacy of an Investigational Device (IDE) called the Cross-Seal Suture-Mediated Vascular Closure Device System. This device has not yet been approved by the FDA for use on…
The purpose of this outpatient study is to examine if oral Spironolactone (100mg/day) in addition to loop diuretics (water pills) can improve signs and symptoms of fluid retention in patients with heart failure and prevent hospitalization.
This clinical trial is for patients diagnosed with carotid artery stenosis that are at high risk of a stroke. Carotid artery stenosis develops as a result of plaque buildup in the carotid artery. Over time plaque buildup creates a narrowing of the carotid artery, restricting the flow of blood. Thus, increasing the risk of stroke. In this research study the…
The purpose of this study is to find out more about how the study drug called entrectinib will be used in children, adolescents and young adults with treatment-resistant solid tumor in brain or body. This is a phase 1/1b study, divided into a dose escalation portion (different dose will be tested) and a dose expansion portion (one dose will be tested) in…
This is a prospective, multi-center, single-arm study aimed at finding out if the clinical performance of a device called the Orsiro stent, in a real-world setting is similar to the clinical performance observed for the device in the BIOFLOW-V IDE pivotal trial. After receiving the Orsiro stent, you will be followed through 5 years of follow-up, with…
This study is evaluating an investigational medication to see if it is safe and if it works well in children andadolescents who have mild to moderate ulcerative colitis (UC) or are in remission. Ulcerative colitis (UC) is a chronic disease of the last section of the intestine, which is also known as the colon. If you have UC, the lining of your colon…
The purpose of this study is to evaluate the safety and performance of the CytoSorb device to reduce plasma free hemoglobin when used intra-operatively with cardiopulmonary bypass (CPB) in subjects undergoing cardiac surgery.
The Breathe Easy Early ORBEX Study is a three -year study to identify if a daily capsule of Broncho-Vaxom may help prevent or delay young children from developing wheezing or asthma- like symptoms. Other studies have found that Broncho-Vaxom can help prevent upper respiratory infections and stimulate immune defenses, and has been safely and effectively used…
The purpose of this study is to compare the effect of the investigational drug, Mavacamten, to a placebo (an inactive drug). This is being done to evaluate whether Mavacamten is safe in obstructive Hypertrophic Cardiomyopathy (HCM) patients and helps to improve symptoms or ability to exercise. Mavacamten is an investigational drug. This means that it has…
The purpose of this study is to collect data for evaluating VFR (Virtual Flow Reserve) in comparison with standard FFR (Fractional Flow Reserve) when patients undergo a percutaneous coronary intervention (PCI) to treat blockage or narrowing in the heart artery or arteries.
The purpose of this study is to find out if the mitral valve can be safely replaced using a procedure that issimpler than the open-heart procedure being used today and may be safer for patients who are at ahigher risk from conventional open-heart surgery. The device being studied would be implanted without the need for an open-heart procedure and without…
This trial is looking to enroll patients with heart failure in order to study the effect and safety of the study drug, vericiguat, when compared to a placebo. Patients will remain on their regular standard of care treatment and will receive either a placebo or Vericiguat. All patients will be monitored closely by the study team.
The purpose of this study is to investigate how mothers with babies with congenital heart disease feel about breastfeeding. We will ask you to fill out a survey while you are in the hospital at around the time of delivery and another survey approximately three months later to see how you feel about breastfeeding. In addition to the survey data, the study…
The LOTUS Edge Valve System is intended to improve aortic valve function in symptomatic subjects with severe aortic stenosis who are at intermediate risk for standard surgical aortic valve replacement (SAVR), including those who have a bicuspid native valve. The study will include subjects presenting with symptomatic severe aortic stenosis who are…
The purpose of this study is to find out more about how the study drug called talimogene laherparepvec will be used in children/adolescents/young adults with advanced solid tumors not involving the central nervous system that are available for direct injection. This is a phase 1 study, multicenter, open-label study, that means all subject enrolled in the…