Cardiac
A Randomized, Multicenter, DoubleÂBlind, PlaceboÂControlled Study of AC607 for the Treatment of Acute Kidney Injury in Cardiac Surgery Subjects
People who have heart surgery that requires them to be on a cardioÂpulmonary bypass pump are at risk of developing acute kidney injury (AKI), although it does not happen to everyone. Currently, there are no drugs available for AKI and the only way to treat someone with AKI is with supportive care like managing the amount of fluid they get, and possibly dialysis. The purpose of this research study is to find out if an investigational treatment, called AC607, can help people who have had heart surgery and who develop AKI after their operation. (Yoshifumi Naka, MD, PhD)
An Evaluation of Rigid Sternal Fixation in Supporting Bone Healing and Improving Postoperative Recovery: A Prospective, Randomized Trial
The purpose of this study is to compare 2 methods of closing the sternum (breastbone) after heart surgery. This study is a research study to determine if one method of sternal closure results in better healing of your breastbone compared to the other. This study will also determine if there are differences in the amount of pain, the use of pain medication, and functional recovery following heart surgery. (Yoshifumi Naka, MD, PhD)
Biventricular Pacing after Cardiac Surgery BiPACS Trial
Cardiovascular Effects of Vitamin D Deficiency in Primary Hyperparathyroidism
Primary hyperparathyroidism is a condition characterized by overactivity of the parathyroid glands leading to elevated parathyroid hormone and blood calcium levels. Subclinical cardiovascular disease has been demonstrated in primary hyperparathryoidism but it is not reversible by parathyroidectomy. This project will investigate whether vitamin D deficiency is responsible for some of the cardiac abnormalities that have been demonstrated in primary hyperparathyroidism. (Marcella Walker, MD)
Carotid Artery Stenosis: Comparing the Xact RX Stent and Emboshield Cerebral Protection System with Carotid Endarterectomy (ACT I/Abbott)
The purpose of this study is to demonstrate that carotid artery stenting using the Xact RX stent with the Emboshield Cerebral Protection System is equivalent to carotid endarterectomy (CEA) in treating carotid stenosis. (William Gray, MD)
Comparing Carotid Stents and Carotid Endarterectomy (CREST/NIH)
This study compares carotid stenting and carotid endarterectomy (CEA). (William Gray, MD)
Molecular and Genetic Analysis of Aortic Aneurysms
The specific aims of this study are: 1. To characterize gene expression differences between normal and aneurysmal aortas; 2. To correlate clinical behavior of aneurysms with differential gene expression in a range of diseased aortas; 3. To evaluate the products of differentially expressed genes as serum markers for an increased risk of complications. (Allan Stewart, MD)
Multisite Ventricular Pacing After the Fontan Procedure
Ventricular dysfunction occurs in up to 25% of patients after cardiac surgery with cardiopulmonary bypass (CPB) for repair or palliation of congenital heart disease. Ventricular dysfunction has been linked to patient morbidity after Fontan palliation of “single ventricle”. Multi-site Ventricular Pacing (MSVP) benefit patients with chronic heart failure by increasing stroke volume and cardiac output (CO). The improvement results from reversal of ventricular dyssynchrony, which increases the efficiency of pump function. Similar benefits have been demonstrated in acute ventricular dysfunction after CPB for repair of acquired heart disease. Our study aims to determine the efficacy of MSVP after Fontan palliation for “single ventricle” congenital heart disease. MSVP after the Fontan operation will utilize two pacing leads on the single ventricle, and will optimize Atrioventricular Delay (AVD) and Interventricular Delay (IVD) , which in this case is the timing between two leads on the same ventricle. Our hypothesis is that optimized MSVP will increase CO by 10% with no increase in inotropes, afterload reduction, or volume infusion. Each patient will serve as his/her own control. These results will provide preliminary data for clinical trials utilizing MSVP to improve care of patients after Fontan palliation, both in the ICU during recovery and long-term. (Henry Spotnitz, MD)
Optimized Biventricular Pacing in Allograft Recipients or Biventricular Pacing Before Transplant (BiBeT)
The purpose of this study is to investigate the mechanics and methods of optimized Biventricular Pacing (BiVP) in patients with NYHA Class III or IV heart failure. This study will examine the ability to optimize BiVP for both Right Left Delay and LV-site in order to maximize CO as compared to traditional atrial (AAI) pacing. Results from this study will also demonstrate the usefulness of optimizing BiVP site-timing to maximize CO as compared with AAI pacing. Patients with heart failure, LV ejection fraction <36% and QRS duration >119 msec will be studied in the operating room just prior to cardiac transplantation. A temporary biventricular pacemaker will be used to pace the failing heart with a random array of BiVP variables of LV site and RLD. Cardiac output will be measured directly with an aortic flowmeter. The LV site-RLD combination resulting in the highest cardiac output will then be compared to conventional atrial pacing. Secondary analysis of QRS duration will also lead to testing of the LV site-RLD combination that results in the shortest QRS duration to be compared to atrial pacing as well. (Henry Spotnitz, MD)
PROSPECTIVE, MULTIÂCENTER, RANDOMIZED CLINICAL INVESTIGATION OF TRANSMEDICS® ORGAN CARE SYSTEMTM (OCS) FOR CARDIAC USE
Cardiac transplantation has become an important treatment for patients with endÂstage heart disease. Significant progress has been made over the last 30 years. Despite these advances, problems with the donated heart continue to be a serious problem after cardiac transplantation. There are probably many causes of these failures, injury to the donor heart likely plays a large role. New methods for donor heart preservation may help to further advance cardiac transplantation. Organ Care System uses a combination of technological advances and includes a number of monitors to assess organ perfusion and preservation conditions (Yoshifumi Naka, MD, PhD)
Renal Denervation in Patients with Uncontrolled Hypertension: SYMPLICITY HTN3 IP125
The Symplicity HTN-3 Trial is investigating the use of transcatheter therapies for patients with difficult to control hypertension. The purpose of this study is to provide additional information about a medical device intended to help treat high blood pressure in people whose blood pressure is not controlled despite treatment with multiple blood pressure medications. If you are interested, please contact our Study Coordinator or visit http://www.symplifybptrial.com/ for more information. (Ajay Kirtane, MD)
Surgical Ablation Versus No Surgical Ablation for Patients with Persistent or Longstanding Persistent Atrial Fibrillation Undergoing Mitral Valve Surgery
The purpose of the research is to determine whether surgical atrial fibrillation ablation performed during scheduled mitral valve surgery (surgery to repair a heart valve, a part of the heart which helps control the flow of blood) is better than mitral valve surgery by itself without the surgical ablation. Surgical ablation of atrial fibrillation is a technique used by surgeons to create scars in atrial heart tissue that block electrical signals that may be causing the heart to beat irregularly. (Michael Argenziano, MD)
Surgical Interventions for Moderate Ischemic Mitral Regurgitation
The purpose of the research is to determine whether repairing a mitral valve (a heart valve which helps control the flow of blood) with moderate leakage (regurgitation), at the time of planned coronary artery bypass graft (CABG) surgery, will improve health outcomes of those who receive it compared to those who have the bypass alone. (Michael Argenziano, MD)
Ventricular Function During Neonatal Cardiac Surgery
The purppose of this study is to examine the effect of surgical palliation of neonatal functional single ventricle on heart function. Improved pump function during corrective surgery will be correlated with changes in myocardial properties, since impaired contractility and compliance can be hidden by improved hemodynamics. Specifically, we will: 1.) Examine the effect of acute ventricular volume overload, as well as its reversal, on systolic and diastolic indices of ventricular function. 2.) Evaluate the acute effects of increased afterload immediately after surgical palliation on ventricular function. This will be achieved by the use of quantitative two-dimensional echocardiography (pre-, intra-, and postoperatively at 2 weeks, 2 months, and 6 months), one intraventricular pressure tip catheter, and an electromagnetic peri-aortic flow probe (intraoperatively). Conventional monitoring techniques may not identify patients at risk for poor ventricular function postoperatively. Intraoperative data will also be correlated with demographic data, postoperative course and follow up echocardiographic studies. This study will help improve care of neonates undergoing cardiac surgery and better define the pathophysiology of single ventricular forms of congenital heart disease. (Henry Spotnitz, MD)
