This study is being done on patients who have heart failure, a condition where the heart muscle weakens and enlarges and cannot pump blood effectively. The purpose of this study is to assess the safety and effectiveness of a new device called the AccuCinch Ventricular Restoration System and compare it to treatment with standard heart failure medications alone. The AccuCinch Ventricular Restoration System consists of anchors, which attach to your heart muscle, sliders to connect the anchors and a thread like cord that goes through the anchors and is cinched to make your enlarged heart smaller so it can pump more efficiently. The device is implanted in one of the lower pumping chambers of the heart (called left ventricle). The study will have two groups, the treatment group in which participants undergo the device implant in addition to taking heart failure medications and the control group in which participants are treated with heart failure medications alone. Participation will last up to 5 years.
Participants in this study will undergo a series of adjustments to their pacemaker that will be made while they are undergoing routine, clinically indicated right heart catheterization in the outpatient setting after their left ventricular assist device (LVAD) surgery. Patients will undergo the study procedures while in the catheterization lab under controlled conditions. The study protocol involves increasing the rate that the pacemaker paces at. While the pacemaker is set to pace at different, increasing heart rates, pressures will be measured in the different chambers of the heart utilizing a special type of intravenous (IV) line called a pulmonary artery catheter. Several small blood samples will also be drawn from this venous catheter in order to measure oxygen levels in the blood. It will take approximately 30 minutes to perform the study, and when it is completed, the pacemaker will be returned to its original settings.
This is a Phase III randomized controlled trial of a passive ROM exercise program that will be performed in infants with HLHS and other single right ventricle anomalies following the Norwood procedure at PHN and Auxiliary Centers.
The purpose of this research study is to evaluate a different way to program a Cardiac Resynchronization Therapy Defibrillator (CRT-D) through the use of software built into the CRT-D system. A CRT-D does not cure heart failure, but many people who receive a CRT device note that they feel better. The objective of the device programming required by the study is to see if it reduces the size of the heart and make the heart pump more effectively.
This study involves individuals who have been diagnosed with heart failure, a condition where the heart does not pump blood as well as it should. For this study, a new software program called ALLEVIATE-HF will be studied to see if the software program can help predict worsening heart failure symptoms. The software program will be put onto a medical device called the Reveal LINQ Insertable Cardiac Monitoring (ICM) System. Some participants may already have the Reveal LINQ ICM. If a participant does not already have a Reveal LINQ ICM, then the device will be inserted under the skin. The ALLEVIATE-HF software will help the device identify problems related to heart failure. The device will collect data such as the subjects heart rate and activity level. The information gathered by this system will help the study doctor/healthcare provider and the study team understand an individual subject's risk of having a heart failure event (worsening heart failure symptoms requiring additional treatment or hospitalization) so that steps can be taken to manage their heart failure.
The study will last at least 7 months but may last up to 3 years. There will be at least 2 but up to 4 visits during the study.
The Advanced Cardiac Therapies Improving Outcomes Network (ACTION) is a distributed network-based learning health system (LHS) of care centers, clinicians, researchers and industry representatives partnering with patients who have heart failure and their caregivers with the ultimate aim of achieving health, longevity and quality of life equivalent to the general population. See https://www.actionlearningnetwork.org for more information. The initial focus will be to apply structured quality improvement methods, advanced information technology systems, and sharing of best practices to track and continuously improve health-related outcomes for children with heart failure requiring advanced therapies. In the future, we plan to collaborate with other established registries and learning network (i.e. UNOS, PHTS and Cardiac Networks United) to create an integrated network that improves care throughout all phases of a patient's illness including chronic heart failure, acute decompensated heart failure, ventricular assist device support and transplant.
Patients with Alzheimer Disease and patients with Heart failure (and a control group free from both the previous mentioned conditions) will be evaluated with cardiac and neuropsychological assessments, in order to investigate the relationship between the two conditions. The study consists of two initial visits, and a 4- and 8-year follow-up visit.
Prospective Phase 3b multinational, multicenter, double-blind, placebo-controlled,
randomized withdrawal, parallel group study that includes Screening and 12 weeks Run-in Phase (all subjects will have patiromer initiated and RAASi medications, including mineralocorticoid receptor antagonist (MRA), optimized) and a randomized withdrawal Blinded Treatment Phase.
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 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.