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…
We are conducting a research study on the effect of high insulin levels on the buildup of excessive liver fat ("fatty liver disease") in people at risk for type 2 diabetes. We are seeking adult volunteers, ages 18-65, who have obesity with a body mass index of 30-45, and have been diagnosed with, or are at risk for, prediabetes and metabolic…
We are researchers at Columbia studying the learning and decision making. We are looking for participants over the age of 18, who have been prescribed Trizepatide for weight loss. Participants will be asked to complete an MRI scan and play computer games. Participants earn $25 per hour. Help us understand how the GLP-1 agonists affect brain and cognition!
The Physiology of the Weight Reduced State (POWERS) is a national research study designed to discover and learn what happens to the human body after weight loss and to learn why some people regain their lost weight. Understanding why this happens could help health professionals improve strategies for successful weight loss maintenance after weight loss.…
The purpose of this study is to evaluate if genetic variations are associated with the amount of weight loss with diet and while taking an FDA-approved medication for weight loss. The participation lasts ten months and includes six in-person visits at CUIMC with blood sampling and questionnaires, virtual nutritional counseling, and taking an oral weight…
This is a prospective multicenter study whose purpose is to establish the safety and effectiveness of the Edwards SAPIEN 3 and SAPIEN 3 Ultra valves with Commander delivery system in patients with severe symptomatic calcific mitral valve disease with severe mitral annular calcification (which is a progressive loss of function of the mitral valve due to…
We are conducting a research study on how insulin controls blood sugar in both healthy people and those at risk of type 2 diabetes. We are seeking adult volunteers, aged 18-65, who have body mass indices either in the lean range (18-25 kg/m2) or in the obesity range (30-45 kg/m2) but who do not have prediabetes or diabetes. Participants will undergo a…
We are recruiting volunteers, aged 18-70, for a research study on the buildup of excessive liver fat ("fatty liver disease") in people with or at risk for type 2 diabetes because their bodies are resistant to the actions of the blood sugar-lowering hormone, insulin. To do this, we seek to temporarily induce or accentuate insulin resistance in 14…
We are seeking adult volunteers with body mass index in the obesity range (30-45 kg/m2) to come in for a single study visit where they answer some health questions and have a small volume of blood drawn (25 cc/1.7 tbsp). We will measure levels of the blood sugar-lowering hormone insulin as well as glucose (sugar), certain fats, and other molecules related…
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 is a randomized controlled trial (RCT) that will compare the clinical outcome of MitraClip device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve has been determined to be suitable for correction by MV repair surgery by the cardiac surgeon on the local site heart team. In this trial,…
The study is designed to compare the safety and effectiveness of the PASCAL System to the MitraClip System for reduction of degenerative mitral regurgitation.
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 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…
We're conducting a research study on how much insulin is needed to control blood sugar in people who are made temporarily resistant to insulin's effects. Insulin is the main hormone (chemical signal) that the body uses to lower the levels of sugar in the blood. We are interested in looking at insulin levels because we think that lowering insulin…
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…
This study is designed to look at the safety and performance of The Intrepid TMVR System using transfemoral transseptal access (TF). TF is a procedure that requires access to the femoral vein by an incision in the lower limb between the knee and the hip. The study population is for patients with severe, symptomatic mitral regurgitation (MR), a condition…
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 Millipede Feasibility Study is a prospective, open-label, single-arm study to assess the safety and feasibility of the Millipede Transcatheter Annuloplasty Ring System in subjects with functional mitral regurgitation. The Millipede Annuloplasty Ring System is a novel transcatheter, fully adjustable, complete annuloplasty repair device for the treatment…
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…
The purpose of this study is to evaluate a new device to treat patients who may benefit from the repair of their mitral heart valve due to mitral regurgitation. The device is called the Edwards Cardioband System (Edwards Cardioband System or the device). The device is investigational in the United States but has been approved in Europe. This clinical study…
This trial is a non-randomized, prospective, multi-center early feasibility study to evaluate the safety and performance of the AccuCinch system in patients with Heart Failure and Reduced Ejection Fraction HFrEF