Clinical Trials
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Principal Investigator:
Robert J. Sommer, MDThis is a prospective, multicenter, open-label, single-arm study that seeks to confirm and describe the safety and effectiveness of the GSO device as observed in the REDUCE pivotal IDE study. It is also designed to demonstrate acceptable performance of the GSO device in patients treated with percutaneous, transcatheter PFO closure plus anti-platelet medical management compared to performance goals derived from REDUCE study results. -
Principal Investigator:
Tamim M. Nazif, MDThis 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-expanding implant that restores competency in a sclerotic aortic valve. To implant the device, a surgical incision is made in the femoral vein (incision in the upper leg between the knee and the hip). A catheter is advanced into the heart access... -
Principal Investigator:
Kelly Marie Axsom, MDThe ALLEVIATE-HF study is a prospective, randomized, multi-site, interventional, investigational device exemption (IDE) study. The purpose of the study is to gain experience with utilization of an integrated device diagnostic-based risk stratification algorithm to guide patient care in subjects with NYHA class II and III heart failure. The study will utilize the market-released Reveal LINQ Insertable Cardiac Monitor with an investigational ALLEVIATE-HF RAMware download. The study will enroll up to 300 subjects at up to 30 sites in the US and will characterize the safety of the patient... -
Principal Investigator:
Susheel Kumar Kodali, MDThis is designed for patients with severe, symptomatic mitral regurgitation who are not candidates for conventional mitral repair. -
Principal Investigator:
Susheel Kumar Kodali, MDThe goal of this early feasibility study is to gain initial insight into the basic safety and performance of transluminal (through the blood vessels) implantation of the PASCAL Systems implant (composed of man-made materials). We are trying to evaluate the safety and performance of the PASCAL System with Optimal Medical Therapy (OMT) (also known as standard of care) compared to OMT alone in participants with symptomatic severe tricuspid regurgitation who may not be ideal candidates for tricuspid valve surgery (tricuspid valve repair that is performed via open-heart surgery) and may be... -
Principal Investigator:
Muredach Patrick Reilly, MDAs an academic medical center, we are always working to improve patient and population health. One way that research is supported here is through the Columbia University Biobank (CUB). A biobank is a collection of biological samples and health data that is collected during a patient's medical care. The goal of a biobank is to provide materials for researchers to use in their scientific studies of health conditions such as cancer, heart disease, and diabetes. People who participate in a biobank help researchers find treatments and cures, and they also help their community benefit from improved... -
Principal Investigator:
Edward Felix Lin, MDThe purpose of this study is to collect data about congestive heart failure over several months from patients at home and to assess the ability of a newly developed wireless device to accurately measure changes in the heart and lungs due to CHF. A secondary aim is to determine if the device may predict hospitalizations before they occur. -
Principal Investigator:
Sahil A. Parikh, MDThe objective of this study is to learn more about how safe and effective the Bare Temporary Spur Stent System is when used in patients who have blocked arteries in their lower limbs. The selection of subjects will be those with Critical Limb Ischemia (CLI), a form of Peripheral Arterial Disease (PAD) in which an artery (blood vessel) in the lower leg (calf) may have become blocked. To improve blood flow to the lower leg, the study doctor will open up this blockage using the Bare Temporary Spur Stent System. -
Principal Investigator:
Sahil A. Parikh, MDThis study is to collect information about the symptoms and treatments of patient who have severely clogged arteries and treated with commercially available Boston Scientific Corporation drug-eluting devices marketed for treatment of lesions located in the peripheral vasculature. If you choose to be part of this research, we will ask you to be involved in office visits at 6, 12, and 24 months as well as follow-up at 36, 48, and 24 months will be completed in office or remotely. Your involvement in the research will last for 5 years. There are no or minimal risks from participating in this... -
Principal Investigator:
Robert J. Sommer, MDThis study will evaluate Patent Foramen Ovale (PFO) closure for migraine headache relief using a device called the GORE CARDIOFORM Septal Occluder. A patent foramen ovale (PFO) is a hole in the heart that didn't close the way it should after birth. During fetal development, a small flap-like opening the foramen ovale is normally present in the wall between the right and left upper chambers of the heart (atria). Most patients with a PFO do not have any symptoms. However, the condition may play a role in migraine headaches and it increases the risk of stroke, transient ischemic attack (stroke...