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…
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…
The purpose of this study is to test the good and bad effects of the combined treatment, using the drugs cetuximab and avelumab as well as avelumab by itself. Avelumab is a drug that works by triggering the immune system so it can try to attack the cancer again. Avelumab works in a similar way to cemiplimab, which is the usual drug for treatment of your…
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.
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 adult subjects with head and neck cancer (oral cavity, oropharynx middle part of the throat, hypopharynx bottom part of the throat, or larynx part of throat between the base of the tongue and the windpipe) that has either returned after treatment (recurrent) or is newly diagnosed. If newly diagnosed, the cancer must be metastatic,…
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…
This study is for patients with melanoma, non-small cell lung cancer (NSCLC), or squamous cell cancer of the head and neck (SCCHN) that has a protein called B7-H3 on the tumor cells or blood vessels in thetumor. The purpose of this study is to test the safety, tolerability, and most effective dose ofMGA271 in combination with ipilimumab (also called Yervoy…
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…
This study is for patients with recurrent or metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN). This study will test the safety of an experimental anti-cancer drug (MEDI4736). MEDI4736 is an antibody (a protein produced by the defense system of the body immune system) that has been made in the laboratory. MEDI4736 boosts the ability of your…
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.
The purpose of this study is to determine the effectiveness and safety of study drug MEDI4736 monotherapy, tremelimumab monotherapy, and MEDI4736 and tremelimumab combination therapy in the treatment of patients with recurrent or metastatic PD-L1-negative squamous cell carcinoma of the head and neck who have progressed during or after treatment with…
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 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.
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 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.