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…
This research study seeks to better understand the biological and behavioral aspects of specific phobia and evaluate how the "Self-Distancing" technique might help youth confront their fears. The study will be conducted at Columbia University in Manhattan. Participation involves completing questionnaires and attending a single visit for a…
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.
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…
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…
Sertraline (also known as Zoloft) is an FDA approved medication that is used to treat anxiety in children and adolescents. We aim to better understand how children and adolescents with anxiety respond to sertraline and whether we can predict medication response. If your child is eligible, he or she can participate in a research study and will receive both a…
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…
We are currently enrolling individuals with social anxiety disorder to participate in this study. The purpose of this study is to assess whether a brief computer-based research treatment helps improve social anxiety symptoms. For eligible participants, this study will involve a brief, novel research treatment for social anxiety, delivered in 8 or 12…
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-…
The goal of this study is to advance our understanding of how the brain processes emotion in adolescents. Adolescents with and without symptoms of anxiety are invited to participate. This study takes place over two days and includes an evaluation and a brain imaging session. Participants will be compensated up to $250. This study does not provide treatment.
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 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
RESEARCH STUDY:Brief Intervention for Public Speaking Fears (IRB#7293).- Are you between the ages of 18 - 60?- Do you have bothersome fears of public speaking?- Are you interested in trying a novel intervention?This research study tests whether a brief intervention using a medication called propranolol is effective at reducing public speaking fears. This…
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…