
NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial...
Heart DiseasesArrhythmia1 moreThis trial evaluates the safety and effectiveness of catheter ablation for PAF. The investigational catheter being studied is the NAVISTAR® THERMOCOOL® irrigated-tip catheter. At the time of this study, the NAVISTAR® THERMOCOOL® Catheter was FDA-approved for commercial distribution in the U.S. for treating patients with Type I atrial flutter and drug refractory monomorphic sustained ventricular tachycardia post myocardial infarction. The catheter was approved for use in Europe for endocardial ablation for treating cardiac arrhythmias.

Acute Effects of Inhaled Treprostinil in Fontan Patients
Congenital Heart DiseaseIn this pilot study investigators propose to explore the effects of a locally delivered inhaled pulmonary vasodilator (inhaled treprostinil) on exercise performance, pulmonary blood flow, venous pressure response and vascular function in stable Fontan patients. Investigators will also assess the effects of resting and acute rises in exercise induced systemic venous pressure on liver stiffness and will also assess whether treprostinil will attenuate the acute stiffness increase that investigators expect to see. This will be a prospective, randomized, double-blinded placebo controlled, crossover trial. Following recruitment and informed consent, each participant will undergo three study visits, including baseline testing (visit 1), followed by two sets of exercise and vascular function tests (visit 2 and visit 3) at CCHMC. Twenty-six patients will be enrolled in this study.

Evaluation of VITLS Compared to Traditional Inpatient Monitoring in Cardiac Shunt-Dependent Children...
Congenital Heart DiseaseDesaturation of BloodWe are seeing how well a remote monitoring device that looks like a sticker placed on the chest, under the arm can monitor a child's vital signs including oxygen levels compared to the way that we usually get these measurements. The goal of this study is to see if the new sticker can be used for monitoring patients with cardiac shunt dependent heart conditions from home once they are discharged home. Participating children will be monitored for 6-72 hours with the new sticker in addition to his/her usual hospital monitors so the new sticker device can be compared to our hospital monitors.

Aortic Valve Regurgitation Acquired After Left Ventricular Assist Device Implantation: an Outstanding...
Aortic Valve Regurgitation AcquiredTo investigate histological structure and molecular changes involved on the onset of AVD after left ventricular assist device (LVAD) implantation and to compare them with those of patients operated on for severe aortic regurgitation. Methods: Bridge-to-transplant patients with AVD post-LVAD implantation are included. Patients operated on for severe aortic regurgitation are included as control. Clinical and TTE data are compiled. Samples of aortic valve are collected at the time of the intervention. RNA-sequencing analysis is performed in LVAD patients and variations of gene expression are validated by real time qPCR in both. Blood sampling are performed pre-operatively and at one-month follow up to assess the plasma level of previously identified gene modulators. In-vitro studies exposing VICs and VECs to several mechanical stimuli are performed for validation. Conclusion(s) Taking together, the in-vivo and in-vitro models would provide important information for the understanding of valve remodeling and disease. ECM gene modulators could represent pertinent molecular targets to stop the progression of AVD

Prevention of Contrast Induced Nephropathy in Patients With Advanced Renal Dysfunction Undergoing...
Kidney DiseaseChronic1 moreThere is a pressing need to find effective strategies for the prevention of contrast induced nephropathy in patients with advanced renal dysfunction. The current study was designed to assess the efficacy of a new protocol for preventing contrast induced nephropathy in patients with advanced renal dysfunction undergoing coronary interventions

ABSORB Post-Approval Clinical Study
Ischemic Heart DiseaseThe ABSORB Post-Approval Clinical Study is a prospective, open-label, multi-center, single-arm, non-randomized trial to evaluate the safety of the use of ABSORB in a real-world setting following commercial physician training'and to observe the effectiveness of commercial physician training on appropriate vessel sizing.

The Estrogen Replacement and Atherosclerosis Trial ; Primary Outcome Measure is Mean Minimal Coronary...
Heart DiseaseBackground: Heart disease is a major cause of illness and death in women. To understand better the role of estrogen in the treatment and prevention of heart disease, more information is needed about its effects on coronary atherosclerosis and the extent to which concomitant progestin therapy may modify these effects. Methods: The investigators randomly assigned a total of 309 women with angiographically verified coronary disease to receive 0.625 mg of conjugated estrogen per day, 0.625 mg of conjugated estrogen plus 2.5 mg of medroxyprogesterone acetate per day, or placebo. The women were followed for a mean (±SD) of 3.2±0.6 years. Base-line and follow-up coronary angiograms were were analyzed by quantitative methods. Follow-up coronary angiograms were obtained after an average of 3.2 years of follow up.

IvaBradinE to Treat MicroalbumiNuria in Patients With Type 2 Diabetes and Coronary Heart Disease...
Diabetic Kidney DiseaseTo explore the efficacy of Ivabradine for the treatment of microalbuminuria in patients with type 2 diabetes and coronary heart disease.

PilAm Go4Health Weight Loss Program to Prevent Heart Disease
Type2 DiabetesThis is a pilot randomized controlled trial intervention to improve lifestyle behaviors (physical activity and health diet) for Filipino Americans with type 2 diabetes on metformin. If the PilAm Go4Health intervention demonstrates potential efficacy, it may identify effective intervention strategies to significantly reduce risks for heart disease risks (i.e., metabolic syndrome) in Filipino Americans.

Initiation of Resuscitation While Attached to the Cord With Congenital Heart Disease
Congential Absence of Heart StructureCongenital Malformation of Heart7 moreBefore birth, the placenta (a structure with many blood vessels attached to the inside of your womb) and the umbilical cord (the umbilical cord is attached to the placenta) are sending oxygen and nutrients from the mother's blood through the umbilical cord to the baby. After a baby is born the cord is clamped and babies have to start breathing and support themselves. At the moment when a baby with congenital heart disease is born they will have their cord clamped immediately (this is called immediate cord clamping (ICC)). After ICC the clinical team will start to help a baby transition by carefully monitoring their oxygen saturation (give oxygen if needed), provide warmth, and dry and stimulate. Several animal studies have shown that clamping the cord right after birth might causes the baby to miss the benefits of receiving blood from the umbilical cord / placenta. Delayed Cord Clamping (DCC) is when the baby stays attached to the cord for a longer time. Studies show that DCC has many benefits especially for a newborn baby, such as higher iron storage, less need for blood transfusions, and improved circulation. This can be done while the baby is breathing on its own or while we help you baby breath (this is called resuscitation). This study aims to examine whether DCC while providing resuscitation in infants with CHD is helpful compared to immediate cord clamping. Prior to the birth of your baby, a sealed envelope will be opened and your baby will be randomly assigned to either the DCC with resuscitation group or the ICC group. 40 babies will be enrolled into this study, 20 in each group. In the DCC group, the umbilical cord will be clamped after 120 seconds during which time your baby will receive the care he/she requires by the NICU team. In the ICC group, the umbilical cord will be clamped immediately and he/she will be brought over the resuscitation bed to be cared for by the same team.