The objective of the study is to evaluate the safety and efficacy of the JenaValve Pericardial TAVR system when treating patients with aortic regurgitation. Aortic Regurgitation is a condition that develops when the heart's aortic valve does close tightly, therefore the blood leaks back into the heart chamber. The JenaValve Pericardial TAVR system will…
This study is called a screening study and the purpose of this study to find better ways to diagnose and treat leukemia that has come back after treatment or difficult to treat. Bone marrow, blood, and medical information about cancer and treatment will be collected. The results from this screening study may give other information about leukemia that is…
The high incidence and variety of conduction disturbances post-TAVR represents a major challenge in the periprocedural management of TAVR recipients. Despite the growing body of knowledge on this topic, the large variability in the management of these complications has translated into a high degree of uncertainty regarding the most appropriate treatment of…
This prospective, multicenter trial is looking at the investigative device called the ACURATE Transcatheter Aortic Valve System for TAVR to see if it is safe and effective in treating patients with severe symptomatic native aortic stenosis. The ACURATE Transcatheter Aortic Valve System for TAVR is designed for iliofemoral access and delivery of a self-…
Aortic stenosis (AS) or narrowing of the arteries remains one of the most common valvular diseases in the Western population requiring intervention. The deterioration of the aortic valve is more common in the older population and usually along with coronary artery disease (CAD) requires the need for treatment. This is a study that is collecting safety and…
This is a Phase 1 study of a drug called uproleselan. We are testing new experimental drugs such as uproleselan in the hopes of finding a treatment that may be effective against acute myeloid leukemia, myelodysplastic syndrome or mixed phenotype acute leukemia that has come back or that has not responded to standard therapy. This study looks at how well…
The purpose of this study is to find the best dose of Quizartinib that can be given safely with chemotherapy in children and young adults with acute myeloid leukemia (AML) which has come back or has not responded to the standard therapy. Quizartinib will be given by mouth once a day from Day 6 through Day 28. It will be given in combination with…
This is a prospective, multicenter, non-randomized, single-arm, open-label clinical study, sponsored by Pi-Cardia. Fifteen (15) patients with symptomatic severe Aortic Stenosis (narrowing of the aortic valve) who are considered operable but are not recommended by the heart team for immediate treatment with surgical or transcatheter aortic valve replacement…
The purpose of this study is to find out if the drugs called Nivolumab and 5-Azacytidine can be given safely in children and young adults with Acute Myeloid Leukemia (AML) which has come back after treatment or has not responded to standard therapy. These drugs are thought to work by turning on genes that limit the growth of cancer cells. The study drugs…
The study is to determine whether aortic valve replacement is helpful for patients who have moderate-severe, calcific, aortic stenosis (a narrowing of the aortic heart valve, where calcium has attached to the valve surface, resulting in obstructed blood flow) and do not have symptoms. Subjects will be randomly assigned, l to one of two groups: (1) Treatment…
Although supraventricular tachycardia (SVT), including atrial flutter (AF), are the most common causes of intended in-utero fetal therapy, none of the medication used to date has been evaluated for their effects on the mother and her baby in a randomized controlled clinical trial (RCT). In the absence of such evidence, there is no consensus for the optimal…
The study is to determine whether aortic valve replacement is helpful for patients who have severe, calcific, aortic stenosis (a narrowing of the aortic heart valve, where calcium has attached to the valve surface, resulting in obstructed blood flow) and do not have symptoms.
The purpose of this study is to find the best dose of pevonedistat that can be given safely with chemotherapy in children with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) that has either come back or has not responded to the standard therapy. Pevonedistat works by blocking some of the enzymes that are needed for cell growth.
Over time, children and young adults who have had a Fontan operation may find they are more tired, have difficulty breathing and cannot exercise as well as before. Currently, there are no approved medicines to prevent this decline. The purpose of this research study is to learn whether children who have had the Fontan operation can improve their ability to…
This is a Phase 1 multicenter study of Decitabine (DEC) and Vorinostat (VOR) followed by the standard chemotherapy drugs (Fludarabine, Cytarabine and G-CSF (FLAG)). The study treatment is considered experimental because it is not approved by the United States (US) Food and Drug Administration (FDA) for treating children with acute myeloid leukemia (AML)…
The objective of this study is to collect outcome data on valve performance and a pre-specified TAVR care pathway. Transcatheter aortic valve replacement (TAVR) has been shown to be a safe and effective treatment for patients with severe aortic stenosis who are at extreme, high, or intermediate surgical risk. Since CoreValveTM became commercially approved…
This is a Phase 3 multi-center open label randomized clinical trial. The purpose of this study is to learnmore about which anti-rejection (or immunosuppressive) medications best protect infants, children,adolescents, and young adults after they have had a heart transplant. Two different drug regimens will bewill be compared. All of these drugs are FDA-…