This study will examine whether a baroreflex activation therapy device (a small pacemakers that are helpful in heart failure) is beneficial for left ventricular assist device (LVAD) patients. For patients who have a baroreflex activation therapy device and LVAD, we assess whether baroreflex activation therapy helps them feel better and have fewer symptoms. We will also look at whether it helps with recovery of their weak heart. Participation in this study will last 6 months and require 3 clinic visits. At each visit, a participant's symptoms will be assessed, they will have pictures of their heart taken to determine function, and bloodwork will be drawn.
Clinicians use heart proteins to help them detect when there are heart problems (for example, heart attacks). Currently heart proteins can only be measured with blood work. The purpose of this research is to measure heart proteins using a non-invasive device.
This study is being conducted to assess the potential ability of a new method for removing drugs like ticagrelor from blood during heart or aortic surgery, using an adsorption ("sticky") device called DrugSorbTM-ATR. Ticagrelor is a drug that is used to prevent blood cells from clumping together, and therefore decreases the ability of your blood cells to stop bleeding. The DrugSorb™-ATR device may help remove ticagrelor from the blood, and in doing so, reduce the risk of serious bleeding caused by the drug during and after surgery. This device is investigational, which means it has not been approved by the FDA and its safety and effectiveness are unknown.
This study is being done to learn more about Lipoprotein(a) (Lp(a) values in people with known history of Atherosclerotic Cardiovascular Disease (ASCVD). Lipoprotein(a) is a particle that carries cholesterol in the blood. ASCVD is a type of thickening or hardening of the arteries caused by a build up of plaque in the walls of arteries. Plaque is made up of substances such as fats and cholesterol. Plaque can cause blockages in the arteries which could result in a heart attack. High levels of Lp(a) are directly associated with a higher risk of cardiovascular events such as heart attacks or aortic stenosis.
Participation in this study will last up to 2 weeks and involve data collection and a blood draw for a Lipoprotein(a) level unless you've had a level checked in the past. You will be informed of your Lipoprotein(a) level.
The purpose of this study is to use an investigational device called the Atellica® VTL® test system to test a substance in your blood called Troponin that may help with the diagnosis of a heart attack. The purpose of this study is to measure the Troponin level of each participant six times via fingerstick samples and determine how close the measurements are to each other when using six different analyzers. An investigational device is one that is not approved by the US Food and Drug Administration (FDA).
For the Reproducibility analysis, the intent is to evaluate the recoveries of high sensitivity Troponin I using two levels of quality control and plasma matrix with prepared concentrations across the measurement range. The study will be performed at three (3) clinical sites on the Atellica VTLi Analyzer over five (5) days with a minimum of two (2) runs per day. Each run will be performed by one (1)operator with a total of two (2) operators performing runs per day, with runs separated by at least two (2) hours.
A minimum of three (3) operators per site will perform testing on the Atellica VTLi Analyzers for a total of nine (9) operators across the study. For each operator, education/training, years of experience, and occupation will be documented.
Each site will receive five (5) Atellica VTLi test systems for testing in the Reproducibility study. If the site is currently participating in the Atellica® VTLi hs cTnI Assay Emergency Department Clinical Study, at the discretion of the sponsor, the site may repurpose the existing five (5) Atellica VTLi test systems for study purposes.
This study is a prospective, multi-center, double-blind, randomized pivotal trial to evaluate the safety and effectiveness of DrugSorb-ATR to reduce surgical and early post-surgical bleeding in patients undergoing cardiothoracic surgery requiring CPB
≤ 30hrs after the last dose of apixaban or rivaroxaban.Subjects will be randomized to either standard of care (SOC) alone (control arm) or standard of care plus intraoperative apixaban/rivaroxaban removal with DrugSorb-ATR integration in the CPB circuit (investigational arm). Subjects will be followed out for 30 days after the surgical procedure.