This is a prospective, single-center, single-blind, two-arm, 1:1 randomized clinical trial. Patients who have undergone successful elective PCI will be screened with a lipid profile and eligible patients will be enrolled. Non-eligible patients will be enrolled in a registry. Randomization will be stratified by baseline LDL-C level and current statin therapy…
This is a Prospective, multicenter, randomized, parallel-controlled, open-label two-arm trial with an adaptive design that will randomize about 1252 subjects at approximately 120 US and international centers. The study is looking to see if a device called the Impella device will improve the way the heart works as well as if health is improved as compared to…
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 Lugo Lab at Columbia University's Department of Psychiatry is conducting a study of extreme weather events and family functioning. We are recruiting mothers of children between 1-3 year old, who identify as Puerto Rican background, live in Uptown Manhattan or the Bronx and identify as low-income. You will be compensated for your time! All…
The primary objective is to demonstrate that physiologically-guided stenting using the Philips SyncVision iFR co-registration is superior with respect to clinical outcomes compared to PCI guided by angiography alone. Secondary objectives include: To evaluate the cost-effectiveness of physiology guidance with SyncVision compared to a standard of care PCI…
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…
This study is trying to determine if using a Dynamic Coronary Roadmap (which is a software used along with an x-ray imaging system) reduces the total iodine contrast volume per Percutaneous Coronary Intervention (PCI) procedure compared to procedures performed without Dynamic Coronary Roadmap. This X-ray system provides imaging support while directing the…
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…
This study has been designed to treat patient with coronary artery disease and demonstrate the superiority of the OCT device used to select and guide the stenting procedure when collecting images and flow measures inside the blocked artery.
This is a research study designed to look at the safety and effectiveness of the TriGUARD 3 cerebral embolic protection device in patients undergoing transcatheter aortic valve implantation (TAVI). The purpose of the study is to assess whether the TriGUARD 3 can prevent death, stroke, more subtle signs of brain injury, and/or silent brain injury as measured…
The purpose of this study is to collect data for evaluating VFR (Virtual Flow Reserve) in comparison with standard FFR (Fractional Flow Reserve) when patients undergo a percutaneous coronary intervention (PCI) to treat blockage or narrowing in the heart artery or arteries.
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…
We are seeking children ages 7 - 12 to participate in a research study on irritability. The study consists of two lab visits. During the first lab visit, we will interview you and your child. During the second lab visit, your child will complete 3 tasks on the computer while electroencephalography (EEG) data are collected. We will also ask you to complete…
A study evaluating the placement of any guidewire beyond complex narrowed arteries that are relatively common in patients undergoing ballon angioplasty (a procedure where a balloon is used to stretch open narrowed arteries). At least one Teleflex guidewire and at least one Turnpike catheter is used. The guidewires and catheters that are being studied are…
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 current study is to investigate the efficacy of a group model of Family Nurture Intervention in ameliorating behavioral problems in preschool-aged children. The behavioral, neurobiological and clinical insights gained from this project may eventually lead to better treatment of emotional, behavioral and developmental disorders. The…
Parents! Join our research study! For families with 2-4 years olds, Complete from the comfort of your own home. Involves: Complete questionnaires; Collect a stool sample from your child; Provided with an easy to use kit and video instructions; Earn $25 for participating.
The Saranas Early Bird Bleed The Saranas study uses a device is called the Early Bird Bleed Monitoring System (EBBMS) and it is intended to provide physicians with an early indication of a potential internal bleeding complication due to vessel injury that may occur during the procedure before any symptoms present.