You may want to join this study because your heart condition may respond to a device-based therapy called cardiac modulation therapy called the OPTIMIZER System. The OPTIMIZER INTEGRA CCM-D System, also known as a Cardiac Contractility Modulation Defibrillator, is an investigational device system that combines CCM therapy and ICD therapy into one device.…
The 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…
We are doing this study to collect sensor and heart failure (HF) event data that will be used to develop and test new diagnostic (not providing therapy) features for the insertable cardiac monitor (ICM) systems. ICMs are small devices implanted under the skin and are now widely used for the long-term monitoring and detection of abnormal heart rhythms. ICMs…
The purpose of this research study is to understand if aspirin is needed in patients heart failure implanted with the HeartMate 3. Patients with devices like the HeartMate 3 take two blood thinner medicines, specifically warfarin and aspirin. Patients implanted with devices like the HeartMate 3 experience both clotting and bleeding complications. Data…
We are seeking adults with cardiovascular disease who identify as Black/African American or LatinX, and/or their caregivers, as well as community health workers working in primarily Black/African American or LatinX neighborhoods of NYC, to participate in a brief (30-minute) interviews over the phone or Zoom to discuss attitudes and perceptions related to…
The purpose of this research is to evaluate the safety and performance of an experimental system called the Aortix System. The system is being designed for use in patients hospitalized for a worsening of their heart failure symptoms and who also show signs of strain on their kidneys. The Aortix System includes a pump, which we hope may help the heart and…
The purpose of this clinical study is to evaluate the safety and efficacy of two doses of GT005 administered as a single subretinal injection in individuals with geographic atrophy secondary to dry age-related macular degeneration (AMD) who qualify, based on genetic testing.
This is a prospective, single arm, three stage, multi-site, clinical investigation evaluating the safety and efficacy of the Carag Bioresorbable Septal Occluder (CBSO) to treat patients with clinically significant hole in the atrial septal defect compared to other commercially approved devices. The study is being done to determine the safety and efficacy of…
This prospective, multicenter, open-label, single arm, first-in human study will enroll up to 75 subjects aimed at examining the performance of the LAAC device for LAA closure.
Glaucoma is a given name of a group of diseases that affect the retinal ganglion cells in the eye and the optic nerve. Glaucoma cause degeneration of the retinal ganglion cells in the retina and their projections (axons) that form the optic nerve. Retinal ganglion cells and their axons transmit all of our vision information from the eye to the brain through…
The abicipar is an injectable medication stored as a liquid in a single-use glass vial for delivery into the back of the eye. The active component is a protein drug that was made using bioengineering technology. It was designed to bind to and inactivate a protein called Vascular Endothelial GrowthFactor (VEGF) that plays an important role in causing AMD.…
The purpose of this research is to find out whether it is safe to shorten the length of time that people at high risk for bleeding take blood thinners after being treated with a coronary stent.
Macular degeneration is a progressive eye disease that damages the macula. The macula is the part of the eye that is responsible for central vision, which is needed to perform straight-ahead activities, such as reading, driving, or watching TV. This research is being conducted to learn about the safety and efficacy (how effectively the study drug works) of…
This study is for patients with Coronary Artery Disease (CAD) and require a stent placement. The purpose of this clinical research study is to assess the safety and effectiveness of the Orsiro stent or a non-investigational Xience stent. The Orsiro stent is investigational, which means it is not yet approved by the FDA and can only be used in research…
This study is for patients with Glaucoma. The purpose of this study is to investigate the safety and effectiveness of a study drug called Bimatoprost Sustained Release (SR) compared to treatment with eye drug Timolol. The Bimatoprost SR is an implant that is very small, is biodegradable (dissolves naturally in the body), and contains the bimatoprost drug.
The purpose of this research study, is to learn whether an experimental device (called Evolut R) can help clear hardened blockage in coronary arteries (blood vessels that feed the heart muscle) in patients with a disease is called aortic stenosis.Subjects that choose to participate and are eligible will have their interventional cardiologist use this device…
Stargardt macular degeneration isa genetic condition, which in mostcases causes vision loss early in lifeand leads to legal blindness. Thereis currently no FDA-approvedtreatment.This trial will evaluate the safetyand effects of ALK-001, a newpotential drug treatment, on theprogression of Stargardt disease.ALK-001 is a capsule administereddaily by mouth.This…
The purpose of this study is to evaluate the NuPulseCV intravascular ventricular assist system (iVAS), a device similar to an Intra-aortic Balloon Pump (IABP) that helps circulate blood from the heart throughout the rest of the body. This study aims to: (1) See if the iVAS improves your blood circulation (2) Better understand how the iVAS device could…
The purpose of this study is to see if a new medication called ticagrelor given twice daily ismore effective than aspirin alone in preventing the occurrence of heart attack, stroke and/ordeath due to cardiovascular events in patients who have type 2 diabetes. Ticagrelor is anantiplatelet therapy (stop platelets from clumping together) and is approved for…
The purpose of the study is to characterize von Willebrand Factor (VWF) profiles in patients receiving HeartMate 3 (HM3) and compare them to HeartMate II (HMII) Left Ventricular Assist Device (LVAD).
The purpose of this study is to survey patients who have undergone a percutaneous coronary intervention (PCI) at Columbia University Medical Center in which the physician used a stent called the Promus Premier stent. Patients will be asked to do a brief 15-30 minute survey regarding their health since the PCI and stent implantation.
Glaucoma is the leading cause of irreversible blindness worldwide. The most important test to detect progression is visual field testing. However, this test is very subjective, often unreliable, and variable. One of the main causes of unreliable tests is the lack of attentiveness or concentration during the test. Previous studies have shown that listening…
The purpose of this study is to evaluate the Biosensors BioFreedom Biolimus A9 Drug Coated Coronary Stent on people with coronary artery disease (blockages in the heart arteries) to determine if it is safe and effective.