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 purpose of this study is to find out if IW-3300, an investigational new drug, helps bladder pain when given as a rectal (inserted into the anus) foam. The study will test IW-3300. IW-3300 is a new drug that has been developed for treating people like you with interstitial cystitis/bladder pain syndrome. It is not yet approved by the United States Food…
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 the study is to investigate if Cysview and blue light is better than white light in detecting tumors in individuals with bladder cancer prior to and during surgery that are in follow-up for tumor recurrence. Cysview is an FDA approved drug that is used in combination with a lamp from KARL STORZ to detect tumors in the bladder (KARL STORZ D-…
This study is for adults with Overactive Bladder. The purpose of this registry is to collect information about patients who have Overactive Bladder (OAB) and who are receiving either mirabegron or another approved antimuscarinic medication (single drug). To collect this information, the study Sponsor has created a research registry. A registry is a kind of…
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…
You will be randomly assigned to complete questionnaires via either a paper format, web-based format, or smartphone format. About 2 weeks later but before treatment begins, you will be asked to complete a different form of the questionnaire either in the office or at home. You will be emailed and/or called by research staff to remind you to complete the…
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).
This clinical trial is for patients diagnosed with carotid artery stenosis that are at high risk of a stroke. Carotid artery stenosis develops as a result of plaque buildup in the carotid artery. Over time plaque buildup creates a narrowing of the carotid artery, restricting the flow of blood. Thus, increasing the risk of stroke. In this research study the…