This is a prospective, multicenter clinical trial for individuals presenting to the Emergency Department with suspicion of acute heart failure. A blood sample collected will be used to compare the standard of care BNP test used at the local site to the investigational assay from Beckman Coulter (sponsor).
The diagnosis and treatment of patients at each site will use an FDA-cleared BNP or NT-proBNP assay under the site's standard of care and NOT the investigational assay.
This research study aims to determine a less invasive way to assess heart function by taking measurements of the heart while subjects are performing an exercise cardiac MRI. Subjects will undergo two exercise phases and MRI measurements will be taken after each exercise phase. These measurements will be compared to available clinical data (including demographic, hemodynamic, radiologic, and functional) and future outcome data.
This is a study for patients with high blood pressure. The purpose of this study is to evaluate the safety and effectiveness of renal denervation while you are still on your blood pressure medications. Renal denervation is a procedure that destroys the nerve fibers that run along the kidney blood vessels interrupting nerve signals that may cause high blood pressure.The purpose of the treatment (renal denervation) is to lower blood pressure. You will undergo renal angiography (RA), which you may or may not receive the study treatment (depending upon your study assignment). The sponsor has manufactured a new drug/device combination product called the Peregrine System™ Kit (also referred to as the Peregrine Kit). The Peregrine Kit contains a device, the Peregrine System™ Infusion Catheter (also referred to as the Peregrine Catheter), and a drug dehydrated alcohol for injection (also referred to as alcohol). Therefore, the effectiveness of the study catheter and the alcohol (Peregrine Kit) will be assessed by how well the treatment reduces your blood pressure. The participant will be asked to return to the doctor's office for follow-up visits at 4 and 8 weeks, 3, 4, 5 and 6 months, and 1, 2, and 3 years after the procedure. At the 1 year visit, the participant will find out if he/she got the treatment, and if he/she did not, they can choose to cross-over to the treatment if they still meet eligibility criteria.
The purpose of this study is to build a repository (collection) of heart signals from eligible subjects. The experimental part of this study is the collection of heart signals using a device similar to a heart monitor called the Phase Signal Acquisition System. The signals will be electronically sent to a storage center and paired with the subject's heart catheterization results for future use in research and development activities sponsored by Analytics 4 Life. The study will include up to 1500 participants at up to 20 research sites in the United States and will require approximately one hour of the subject's time. There are no follow-up visits. .
The purpose of this study is to build a repository of heart signals from eligible subjects. The experimental part of this study is the collection of the participant's heart signals using a device similar to a heart monitor called the Phase Signal Acquisition System. The signals will be electronically sent to a storage center, then compared to the results of the participant's heart catheterization and saved for future research and development activities sponsored by Analytics 4 Life. The study will include up to 2500 participants at up to 20 research sites in the United States and will require approximately one hour of the subject's time. There are no follow-up visits.
The proposed study will investigate the effect of congenital heart disease (CHD) on rates of employment, community participation, neuro-psychological comorbidities, and quality of life (QOL) in adults with Down syndrome. Knowledge of these longitudinal functional outcomes may assist clinician guidance to families and highlight needs for specific resources and interventions to achieve optimal outcomes in adulthood.
Patients who present to MUSC's Chest Pain Center with acute chest pain and have undergone coronary computerized tomography angiography or triple rule-out computed tomography imaging showing an intermediate stenosis will be prospectively selected. Consented patients will then have their clinical indicated coronary computerized tomography angiography or triple rule-out computed tomography imaging undergo an expedited computed tomography-fractional flow reserve analysis analysis. This analysis will be provided to Chest Pain Center physician of record to aid in downstream patient treatment decision making. Patients will then be followed-up at 3-months via telephone call and electronic medical records review.
The purpose of this registry is to observe outcomes of heart transplant recipients who are managed with HeartCare. This is done by collecting information about the participant's heart transplant such as test results, biopsy results, and outcomes, storing that information in a database, and using that information for research. HeartCare is a combination of two tests from one blood draw. One test, AlloMap®, is a well-established test for heart transplant recipients. The other test, AlloSure-Heart, is a new test that directly measures injury of the transplanted heart. HeartCare provides the results of both tests for a noninvasive assessment at time of testing. The registry will be active for up to 5 years after enrollment.
This study is being done to evaluate the impact that monitored anesthetic care (MAC) versus general endotracheal anesthesia (GETA) has on hospital length of stay, rate of ICU admission, or procedural mortality. Also, we hope to determine if the use of Transesophageal Echocardiography (TEE) during GETA impacts device success and durability. Adult patients undergoing transfemoral approach TAVR for aortic valve stenosis may be eligible candidates for this study.
The purpose of this study is to compare the management of CRT device patients using the Medtronic ECG Belt Research System and using routine hospital practice. The participant will be assigned (randomized) to one of 3 study groups. The ECG Belt Research System will be used for data collection at Post-Implant follow-up, 6 months, and 9 months for all groups, in addition to the following:
? Group 1 ? About 200 subjects will be in this group. If participant is in Group 1, he/she will have an ECG Belt guided implant procedure. The ECG Belt Research System will be used to help with the programming of device at Post-Implant follow-up and the 6 month visit.
? Group 2 ? About 100 subjects will be in this group. Participant will have a routine implant procedure. The ECG Belt Research System will be used in blinded mode at your post-implant follow-up visit. It will be used to help with the programming of device at the 6 month visit.
? Group 3 ? About 100 subjects will be in this group. Participant will have a routine implant procedure. The ECG Belt Research System will be used in blinded mode at the post-implant follow-up visit and 6-month visit.
The ECG Belt Research System is investigational because it is not approved to be used outside of a study. The experimental procedures in this study are: The ECG Belt guided implant procedure and optimizing CRT settings using the ECG Belt Research System.