This study will have a 1:1:1 randomization post the implantation of the WATCHMAN DLX Pro Device comparing three different medications used after the WATCHMAN FLX Pro Device is placed. The goal of this study is to see how safe and effective the medications are after the device is placed. The three different arms include the following: Aspirin only for 12-month study duration, reduce dose non-vitamin K antagonist (VKA) oral anticoagulant (NOAC), either commercially available apixaban (preferred) or rivaroxaban for first 3-months, followed by aspirin, or Aspirin +clopidogrel) for first 6 months followed by aspirin only.
This study is enrolling participants with heart failure, a condition where the heart muscle does not pump blood efficiently, with preserved ejection fraction, meaning the heart muscle contracts (squeezes) normally but is unable to relax appropriately. The study involves implanting a pacemaker, a small device that is placed in the upper left chest, and then programming it to either standard settings or personalized settings for you based on your height and heart function. The programming is randomized, meaning assigned by chance, like flipping a coin so you do not get to choose which group you are in nor does your doctor. The study is trying to determine if using the pacemaker to control your heart rate can help you heart failure.
Your participation will last at least 18 months and may be as long as 4.5 years depending on when you join the study. The study will include about 8 visits and include the pacemaker implant procedure as well as testing such as physical exams, 6 minute walk test, echocardiograms (ultrasound test of your heart), blood work, questionnaires and pacemaker checks.
There are risks associated with the pacemaker implant procedure, risks related to study related procedures and the risk of loss of confidentiality. There may be benefit to you and to others with this condition in the future.
This study is evaluating the clinical safety and efficacy of Prevail Drug-Coated Balloon (DCB) in the treatment of in-stent restenosis (ISR) which is the narrowing of heart arteries (blood vessels) previously treated with stents (mesh like medical device that helps keep arteries open) and in new narrowing of arteries in small vessels. The DCB is a small balloon that has medication on it. The medication is designed to reduce the re-occurrence of narrowing in blood vessels. All participants who have a previous stent will be chosen at random to be treated with either the Prevail DCB or the Agent DCB. You will have a 50:50 chance of being assigned to either DCB. The Prevail DCB is considered investigational meaning it has not yet been approved by the Food and Drug Administration (FDA). The Agent DCB is FDA approved. If you are being treated due to a new lesion in a small blood vessel, you will be treated with the Prevail DCB. Study related procedures include the following: electrocardiograph (known as an ECG, which is a test that shows your heart's electrical activity), blood draws, physical examinations, a review of chest pain, and medication history. Participation in this study will take about 5 years and include about 9 visits. Risks include risks related to the DCBs including allergic reaction, GI symptoms or changes to blood counts.
This registry is enrolling subjects who are indicated for renal denervation to treat high blood pressure that has remained high despite treatment. Renal denervation is a procedure where a catheter (a thin, flexible plastic tube with four electrodes near the end) is placed inside the blood vessels that go to the kidneys. Heat is delivered through the electrodes to disable the nerve activity and lower the blood pressure.
Participation in this registry will last about 1-3 years and include 3-6 visits depending on how often your doctor typically conducts follow up visits. Data will be collected including medical history, medications, blood pressure readings, labs, from the procedure and from any complications if applicable. There is a risk of loss of confidentiality and there may be risks that are not known. There may be no direct benefit but the information learned may help others in the future.
This study is looking at people who have recently had a heart transplant to see if a simple blood test can help doctors better understand how the immune system is doing. By checking tiny molecules called microRNAs in the blood, researchers hope to find a way to tell if a patient might have problems like infection or rejection of their new heart. The goal is to help adjust medications so patients stay healthier after their transplant. The study involves taking blood samples during regular doctor visits over three years, but it doesn't change any of the usual care the patients would already get.
The TEAM-HF trial aims to find out whether measuring pressure in the heart and lungs using an implantable device called a CardioMEMS can help identify heart failure patients who are getting worse and may benefit from earlier treatment with a heart pump called an LVAD. It also seeks to determine if patients with advanced heart failure, who are not on IV medications for their heart failure but still have high pressures in their heart and lungs can improve with LVAD therapy.
This study is enrolling subjects who are undergoing a planned radiofrequency catheter ablation (RFCA) to treat ventricular tachycardia (VT). VT is a type of irregular heart rhythm originating from the lower chambers of the heart and is commonly treated with RFCA. During a catheter ablation procedure, flexible tubes are guided through blood vessels in your heart where the location of the source of your abnormal arrhythmia is identified. One of the flexible catheters, called an ablation catheter, is then used to deliver energy from its tip to burn the areas of abnormal tissue within the scar which may be causing the ventricular tachycardias. The ablation procedure utilized in this study will be guided by an Ablation Index; a formula developed to assist physicians performing ablation procedures to guide the duration of applications of radiofrequency energy delivery. Participants will be randomized into the control group, where the study doctor will utilize traditional, non-AI guided ablation, or the intervention group, where the study doctor will utilize AI-guided ablation.
This study will last up to 1 year post-ablation procedure for participants and will include up to 4 visits (ablation procedure and 3 follow-up standard of care follow-up visits). Study procedures include the initial, planned ablation procedure, and collection of medical history and images.
The objective of the study is to evaluate the safety and efficacy of the BrioVAD System by demonstrating non-inferiority to the HeartMate 3™ (HM3) LVAS (Abbott) when used for the treatment of advanced, refractory, left ventricular heart failure.
This study is enrolling subjects with tricuspid regurgitation, which is what occurs when the tricuspid heart valve on the right side of the heart does not close properly and blood leaks backwards. Over time this can lead to symptoms like shortness of breath and fluid build up in the legs, abdomen, and lungs. This study involves a new investigational device called the TricValve® Transcatheter Bicaval Valve system to treat the leaky valve. Investigational means it is not approved for commercial use by the Food and Drug Administration. (FDA) This study will last about 5 years and include about 11 visits. Study related procedures include physical exams, right heart catheterization (an invasive procedure to check pressures inside the heart), echocardiograms (ultrasound test of the heart), CT scan, blood work, questionnaires, hall walk test and procedure to place the device. Risks include those related to the device and procedure such as infection, failure of the device, worsening of your symptoms or other cardiac complications. There are also risks associated with study testing such as radiation risks, blood draw risks, loss of confidentiality and unknown risks. There is potential benefit to you and to others in the future from what is learned from this study.
The purpose of this study is to find out if the investigational drug/study medicine (omecamtiv mecarbil) can reduce the risk of the effects of heart failure (HF), hospitalization, transplantation, or death. It is hoped that the study medicine increases the heart's ability to pump blood throughout the body, but we need to learn more about its effect in patients who suffer the most from HF symptoms. "Investigational" means that the study medicine is still being tested in research studies and has not been approved by the U.S. Food and Drug Administration (FDA). The study drug will be taken by mouth twice daily.
Participation in this study will last for approximately 3 years, however, participation could last from a few weeks to a few years depending on your time of enrollment. These visits will include physical exams, blood draws, electrocardiograms (ECG), echocardiogram (Echo), blood draws, questionnaires along with receiving the study drug. Participants will receive the study drug and have a 2 week wash out period to ensure tolerance. From there, participants will be randomized to either the treatment group (and receive the medication) or the control group (and not receive the medication). The treatment assignment is determined by randomization, where a computer selects at random which treatment group you will be in (like drawing straws). Neither the subject, nor the blinded study personnel will know which group subjects are in. Neither the subject nor the study doctor or study staff will decide what group subjects are assigned.