Cardiac implantable electronic devices (Implantable Cardioverter Defibrillators (ICD),cardiac resynchronization therapy (CRT)) with sensors have been used to develop Heart Failure diagnostics which indicate early changes leading up to hospitalizations. The study is testing a feature that can help predict when your heart failure is getting worse. The feature is called HeartLogic™ Heart Failure Diagnostic Service, or simply HeartLogic.
The purpose of this research study is to test if ARRY-371797 is safe and effective in treating dilated cardiomyopathy caused by a genetic mutation to the LMNA gene. This will be demonstrated by the functional capacity of patients in their 6-minute walk tests and quality of life questionnaires.
Amyloidosis (ATTR) Cardiomyopathy (CM) is a progressive, fatal disease in which amyloid deposits build up slowly, over the course of many years to cause organ damage. This study is evaluating the safety and tolerability of a new drug called AG10 administered to adult patients with symptomatic transthyretin amyloid cardiomyopathy. The participant will be randomized to the study drug or placebo and take the study drug two times per day for 28 days.
The purpose of this research study is to understand the association between heart and brain health in a population of 40-75 year olds. In this study, we will work to better understand blood vessel stiffness and brain function in African American and non-Hispanic white individuals. You will be asked to give blood during the study visit. Additional information will be obtained to help the researcher better understand the blood vessel and brain function data collected. There is only one study visit that last roughly 2 hours and compensation will be available.
The purpose of the study is to test a new way to pace the left side of the heart without using pacing leads, using the WiSE CRT System. In this study, ultrasound will be used to transfer energy from a new type of pacemaker through your body to a special receiver that is placed inside the left ventricle of your heart. The receiver will use the ultrasound energy to pace the heart without using pacing leads.
Peripheral vascular interventions are minimally invasive options for the treatment of patients with peripheral arterial disease (PAD). Unfortunately, the effects of this procedure are short-term and there remains a high rate (40-70%) of restenosis (re-narrowing of the arteries). The purpose of this research study is to determine if the use of the catheter for the delivery of the study drug called paclitaxel, will prevent re-narrowing of the blockage of an artery to be treated in the leg.
The purpose of this research study is to collect information on the safety of the TactiCath SE ablation catheter when it is used to treat atrial fibrillation.This study will collect information about the success of the procedure and report on the number and type of follow-up problems that may occur during or after the ablation procedure (sometimes called adverse events). Data collected for this study will be submitted for review and approval by the FDA.
Pre-eclampsia (PE) happens in pregnancy. It features new onset high blood pressure. It is a major cause of problems to the mother and unborn child. It can lead to health problems in mother and child in the future, which causes a public health problem. We do not know everything about it, but we think it starts in the placenta (the organ that nourishes the unborn child). At this time, we do not know who will get PE. We want to study the placenta, to learn more about the disease.
The objective of this event-driven trial is to demonstrate superiority of empagliflozin 10 mg versus placebo in patients with symptomatic, chronic HF and preserved ejection fraction (LVEF > 40%) under stable treatment of HF symptoms.
?Male or female patient, age >= 18 years at screening.
?Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association classification) class II-IV and preserved EF (Ejection Fraction)(LVEF (Left Ventricular Ejection Fraction) > 40 %) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide) > 300 pg/ml for patients without AF, OR > 900 pg/ml for patients with AF, analysed at the Central laboratory at Visit 1
?Structural heart disease within 6 months prior to Visit 1, OR documented HHF (Hospitalisation for Heart Failure) within 12 months prior to Visit 1
?Stable dose of oral diuretics, if prescribed
?Signed and dated written ICF (informed consent form)
?Further inclusion criteria apply
?Myocardial infarction, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
?Heart transplant recipient or listed for heart transplant
?Acute decompensated HF (Heart Failure)
?Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
?Symptomatic hypotension and/or a SBP < 100 mmHg
?Indication of liver disease,
?Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration Equation))cr or requiring dialysis
?History of ketoacidosis
?Treatment with any SGLT (Sodium-glucose co-transporter) -2 inhibitor or combined SGLT-1 and 2 inhibitor
?Currently enrolled in another investigational device or drug trial
?Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
?Women who are pregnant, nursing, or who plan to become pregnant while in the trial
?Further exclusion criteria may apply
The purpose of this study is to learn if taking a drug called apixaban, given orally, before and after an ablation procedure keeps blood clots from forming and lowers the chance of having a stroke in VT (ventricular tachycardia) patients. Apixaban is a blood thinning drug, also called an anticoagulant. Apixaban is compared to Aspirin. Aspirin is mainly used to treat fever, pain and inflammatory conditions such as arthritis.