This study is enrolling participants with calcific aortic valve stenosis (CAVS) which is a heart valve disease. Blood pumped out of the heart goes through the aortic valve, and in CAVS, calcium builds up causing the valve to thicken over time so it is not able to open as much or as easily and over time this restricts blood flow. This study involves an investigational medication called ataciguat which is being studied to see how well it can slow the progression of CAVS. Investigational means it has not been approved for commercial use by the Food and Drug Administration (FDA). Ataciguat is taken by mouth daily.
Participation in this study will last about 3 years and include about 14 visits. Study procedures include collection of medical data, physical exams, electrocardiogram (ECG - a recording of your heart's electrical activity), bloodwork, echocardiogram (ultrasound test of the heart), CT scan, questionnaires and home monitoring of your blood pressure and heart rhythm.
Risks related to ataciguat include headache, nausea, abdominal pain, diarrhea and dizziness. Study procedure risks include radiation risks, risks of drawing blood and loss of confidentiality.
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 participants who completed the FARAPULSE ADVENT study and are now nearing the 3 year post atrial fibrillation ablation timepoint. Atrial fibrillation is an irregular heart rhythm caused by electrical signals misfiring. An ablation is a procedure in which those signals are targeted and destroyed to stop the atrial fibrillation. This study will consist of reviewing and collecting medical records since the ablation procedure as well as optional questionnaires and wearing a heart monitor for 7 days to capture the heart's electrical activity. There are no study related follow up visits. Study related risks include loss of confidentiality and possible skin reaction to the electrodes (sticky patches placed on the chest to detect the heart's electrical activity). Individual benefit is not expected but the information learned may contribute to knowledge in this field.
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.
This study is studying the investigational medication EDG-7500 for the treatment of obstructive and non obstructive hypertrophic cardiomyoapthy. Investigational means it is not approved for sale by the Food and Drug Administration (FDA) The study will test to see if the medication can help the heart expand and fill to help its workload. The study has 4 Parts, each of varying durations. The study will last a minimum of 2.5 months to a maximum of 19.5 months. Study related procedures include physical exam, electrocardiogram (ECG) - a tracing of the heart's electrical activity, echocardiogram (echo) - ultrasound test of the heart, blood and urine collection, and possible genetic testing. Risks related to the study medication include atrial fibrillation (fast irregular heartbeat), constipation, diarrhea, dizziness/lightheadedness and upper respiratory infection. Other study related risks include loss of confidentiality, unknown risks and risks related to procedures.
This study is enrolling subjects with heart failure and a reduced ejection fraction meaning the heart does not pump enough blood to meet the body's needs. This study is researching an investigational device (study device) called the Alleviant ALV1 System. Investigational means it has not been approved for commercial use by the Food and Drug Administration. (FDA) This study will test the safety and effectiveness of the Alleviant ALV1 System. The Alleviant ALV1 System is intended to create a shunt (an opening) in the heart to allow for proper blood flow through the heart which may improve your symptoms. No device is left in your heart it is just used to create the shunt. This is a randomized study which means subjects are assigned by chance to either have the study device create this shunt or not have the study device create the shunt. Randomization is 50/50 meaning there is a 50% chance to have the study device create a shunt and a 50% chance the study device will not be used. Using the study device to create the shunt is performed during a right heart catheterization (RHC) so all subjects will undergo the RHC but only 50% will have the shunt. Neither the subjects nor the study doctor will know which group subjects are randomized to but other study staff will know in the event this information is needed. All subjects will stay overnight in the hospital after the procedure. Other study related procedures include echocardiograms - ultrasound test of the heart, electrocardiograms (ECG) - a tracing of the heart's electrical activity, blood work, questionnaires, 6 minute hall walk test, and assessments of heart failure status. Risks include risks related to the study device including blood vessel damage from placing the device in the vein to get to the heart, risks from the right heart catheterization such as bleeding or bruising, abnormal heart beats, and risks related to study related procedures. There may be risks that are not known at this time. Participation in this study is expected to last about 60 months and include approximately 15 in person visits and 3 telephone calls.