98 Clinical Trials for Various Conditions
This study is a retrospective chart abstraction for subjects who were enrolled in REN-004. As a retrospective study, all data will be abstracted from the medical records.
The goal of this project is to study whether local anesthetic via the erector spinae plane (ESP) block may be beneficial in minimally invasive mitral valve surgery (MIMVS).
The purpose of this study is to evaluate the effect of RBT-1 (stannous protoporphyrin \[SnPP\]/iron sucrose \[FeS\]) on preconditioning response biomarkers in subjects who are at risk for AKI following cardiac surgery.
The purpose of this study was to evaluate the efficacy of postsurgery treatment with ASP1128 in subjects at risk for AKI following CABG and/or valve surgery. This study also investigated the safety and tolerability of postsurgery treatment with ASP1128, and pharmacokinetic characteristics of ASP1128 in subjects at risk for AKI following CABG and/or valve surgery.
The post-thoracotomy pain (PTP) has been defined as persistent or recurrent pain that lasts for at least 2 month after thoracotomy and is associated with surgical incision or its intercostal nerve cutaneous distribution. The latter has a prevalence of about 15% to 20%. In about 80% of the patients such pain is moderate to severe in intensity and is associated with depression and insomnia. According to its characteristics and possible etiology, PTP is part of the neuropathic pain syndromes. Patients describe their chest wall pain as shooting, burning and numbness which are descriptors often seen in other neuropathic pain syndromes. PTP occurs most likely after partial or complete intercostal nerve damage secondary mechanical trauma (nerve traction or compression) during surgery. The concern is that when robotic surgery for minimally invasive approach to the heart valves or vessels such compression and consequent damage may happen to intercostal nerves. Therapeutic use for a lidocaine patch include post-herpetic neuralgia postthoracotomy pain, stump neuroma pain, intercostal neuralgia, diabetic polyneuropathy, meralgia paresthetica, complex regional pain syndrome, radiculopathy, postmastectomy pain and some other focal peripheral neuropathic pain syndromes. It is an effective and safe topical treatment. Its efficacy demonstrated previously in treatment of intercostal neuralgia and some patients with post-thoracotomy syndrome can be used in treatment of perioperative chest pain related to robotic cardiac surgery. Hypothesis is that the use of topical lidocaine will decrease pain in acute phase after the surgery and decrease intensity of post-thoracotomy pain 6 months after such procedure. The effect of topical 5% lidocaine will be clinically evaluated through prospective, randomized, placebo, double-blind study. Each patient will be assessed at admission and then, one week after Valve Replacement (Recommended surgical procedures do not included harvesting of leg vessels as this could be a potential confounder). Then, one month, three and six month follow-up for all patients by mailing questionnaires and phone calls. Upon admission, as well as 1 week, 1month, 3months and 6 months following surgical procedure, the following tests will be performed: * Pain Disability Index (PDI) * DASS * VAS Pain Score * Opioid use (in MSO4 mg equivalents) * Global Perceived Effect (GPE) or patient satisfaction
Based on the ACC/AHA guidelines for the management of mitral valve disease, quantifying the severity of mitral regurgitation is central to determining which patients are appropriate for correction of their mitral valve by surgery. Specifically, once the diagnosis of severe MR is made, patients are considered appropriate for mitral valve surgery in almost all clinical circumstances. However, there is a significant mortality and morbidity associated with mitral valve surgery The most common diagnostic tool to assess the severity of MR is echocardiography. Several studies have shown that echocardiography parameters used to quantify and qualify MR have high inter-observer and intra-observer variability, calling the accuracy of these parameters into question. Furthermore, studies have shown that there is a significant degree of discordance between echocardiography and MRI when assessing MR, particularly among patients referred for mitral valve surgery. In a recent study, quantification of mitral regurgitant volume MRI was found to be more accurate than echocardiography in patients who underwent mitral valve surgery. All 38 patients who underwent mitral valve surgery in this study were deemed appropriate according the ACC/AHA guidelines based on echocardiographic findings. However, more than 2/3rds of patients who underwent mitral valve surgery in this study did not have severe MR by MRI. Thus, we propose this prospective multicenter trial to assess: 1) the severity of MR by MRI in patients undergoing mitral valve surgery. 2) the impact of mitral valve surgery on quality of life and healthcare costs in the context of MR severity by MRI, 3) assess patient outcomes post surgery in the context of MR severity by MRI and 4) the likelihood of valve replacement vs. repair according to MR severity by MRI.
The purpose of this study is to investigate whether placing Ologen over the posterior plate of the Ahmed glaucoma drainage device during initial implantation will allow the formation of a thinner capsule, and decrease the incidence and/or the extent of IOP elevation during the postoperative period.
This study will determine the effectiveness of Mitomycin-C use in the glaucoma surgery Ahmed valve implantation. Approximately 100 patients will be enrolled, with half receiving the Mitomycin-C treatment and the other half receiving placebo treatment.
Most patients with mitral valve disease are symptomatic with shortness of breath and a limited activity level prior to mitral valve surgery. Despite surgical repair or replacement of the mitral valve, many patients remain symptomatic with an impaired ability to live an active lifestyle. Often after extensive evaluation, no other pulmonary, left ventricular dysfunction, or valvular heart disease is responsible for the continued symptoms, and some of these patients will be limited by persistent pulmonary hypertension (PH) at rest or with exertion that is responsible for limiting their activity level and impacting their quality of their life. It is our goal in the proposed study to systematically characterize symptomatic and asymptomatic patients greater than six months after mitral valve surgery using clinical data, echocardiographic evaluation, laboratory assessment, and in some patients, invasive hemodynamic measurements. The investigators will screen asymptomatic and symptomatic patients with resting echocardiography and also with echocardiography during exercise, as many patients will exhibit exercise-induced PH following mitral valve surgery. Pulmonary artery (PA) pressure will be estimated from echocardiography using Doppler-derived calculations. If elevated PA pressures are observed with echocardiography, then symptomatic patients will undergo right heart catheterization for invasive pressure measurement, which is the gold-standard for the diagnosis of PH. When PH is present and there is a normal wedge pressure (PCWP) during invasive pressure measurement, further assessment to identify potential candidates for PH therapy will be performed. This involves having patients breathe inhaled nitric oxide, a rapid-acting, pulmonary vasodilator with a short half-life. While breathing inhaled nitric oxide, blood pressure, PA pressure, PCWP, and cardiac output will be monitored to characterize individuals who could benefit symptomatically from pharmacotherapy to treat underlying PH. It is important to note that only a small minority of patients exhibit a positive vasodilator response and those with PH and a normal PCWP without an initial vasodilator response would still be identified as candidates for chronic PH therapy. The information generated from this proposed research will make a significant contribution to the understanding of PH in a group of patients in whom it has not been previously studied. Scientific reports on the evaluation of patients with PH after mitral valve surgery are almost nonexistent from the modern era. Furthermore, patients with PH due to mitral valve disease have been excluded from clinical trials of agents currently approved by the U.S. Food and Drug Administration (FDA) to treat PH. Therefore, this work will carefully characterize PA pressures in an objective manner in a group of patients following mitral valve surgery who remain limited with respect to their activity levels. In addition, the investigators will gain a better understanding of the frequency with which patients have PH and a normal PCWP, which identifies a cohort of patients who could have an improvement in their symptoms and quality of life with chronic vasodilator treatment.
Heart surgery involving valve replacement often involves the use of the heart-lung machine for over 90 minutes, and bleeding tendency is frequently seen. Conventionally, platelet transfusion has been the primary therapy to treat bleeding after this type of procedure. More recently, perioperative supplementation of purified fibrinogen (RiaSTAP, CSL Behring) was shown to reduce bleeding and blood product use (plasma or platelets) after heart surgery. The objective of this trial is to demonstrate the clinical equivalency and economic utility of using fibrinogen concentrate, RiaSTAP for the mitigation of post-operative bleeding in patients in lieu of platelet transfusion. Purified fibrinogen concentrate has been approved by FDA, and it has been used for the treatment of acute bleeding episodes in patients with low fibrinogen due to hereditary causes (e.g., afibrinogenemia). Compared to the transfusion of platelets which may be associated with volume overload, bacterial/viral infection, immunological effects and excess blood clotting, purified fibrinogen has several advantages. First, it contains no liquid plasma allowing for low volume infusion. Several viral inactivation/reduction steps are used to prepare the fibrinogen concentrate, increasing its viral safety. No antibodies or white blood cells are contained in the fibrinogen concentrate; therefore transfusion reactions are rare. Although platelet transfusion is widely used after heart surgery, there has been no randomized study to endorse this practice. In this study, patients undergoing heart valve replacement will be randomized to receive either platelet (1 unit) transfusion or fibrinogen concentrate (4g) after heparin anticoagulation is reversed. Subjects will be treated only if there is evidence of significant microvascular bleeding. Fifteen minutes after the initial treatment, subjects will be reevaluated for bleeding. If bleeding continues, subjects will be treated with blood transfusion per institutional standard of care. The primary endpoints for this study are the hemostatic condition of the surgical field and 24-hour total of blood product transfusion.
The purpose of the research is to determine whether treating atrial fibrillation with surgical ablation during scheduled mitral valve surgery is better than mitral valve surgery by itself without the surgical ablation. Surgical ablation of atrial fibrillation is a technique used by surgeons to deaden atrial heart tissue and block electrical signals that may be causing your heart to beat irregularly. There are no new procedures being tested in this study; both mitral valve surgery and surgical ablation are used regularly in patients who have mitral valve problems and atrial fibrillation, although no surgical ablation devices have been approved by the Food and Drug Administration for the treatment of atrial fibrillation. What is not known with certainty, is whether patients with atrial fibrillation who are having planned mitral valve surgery would do better if they also had surgical ablation rather than medication alone to treat their atrial fibrillation.
The goal of this clinical trial is to compare two types of exercise prescriptions in cardiac rehabilitation eligible older adults (60 years or older) with heart disease. The investigators found in a single site pilot trial (insert NCTxxx) that one exercise prescription was better and are now repeating this study in a larger population at two sites (Baystate Medical Center, Springfield MA and Henry Ford Health System, Detroit MI). The main questions the investigators aim to answer are: 1. Compare two different exercise prescriptions in cardiac rehabilitation on exercise outcomes 1. Graded exercise test +Target heart rate range prescription \[GXT-THRR\] 2. Rating of perceived exertion (RPE) 2. What is the role of psychological feedback on fitness outcomes during cardiac rehabilitation and physical activity outside of cardiac rehabilitation. 3. What are the long-term clinical outcomes between the two exercise prescriptions Participants will be asked to: * Complete surveys about physical activity, exercise anxiety, exercise efficacy, and fears about exercising * Perform fitness measures (6-minute walk test, balance tests, stand to sit tests, a 400 meter walk, and handgrip strength) * Attend at least 18 sessions of cardiac rehabilitation after they are randomized to their exercise prescription group * Wear a heart rate monitor and a physical activity monitor per study protocol Participants will be randomized (flip of a coin) to either receive a graded exercise test and psychoeducational feedback or lifestyle education (nutrition for cardiac). The graded exercise test will be used to create a personalized exercise prescription with the target heart rate range calculated from the test and the lifestyle education group will use their ratings of perceived exertion for their exercise prescription.
The investigators are conducting a pilot study to compare cognitive outcomes among Veterans with severe aortic valve stenosis who are scheduled to undergo either aortic valve replacement.
A study to evaluate levosimendan compared with placebo in reducing the composite event rate of all-cause death, perioperative MI, need for new dialysis, or use of mechanical assist (IABP, LVAD or ECMO) in subjects with reduced ejection fraction undergoing cardiac surgery on cardiopulmonary bypass (CPB).
The purpose of the present research study is to investigate for the first time, the safety and tolerability of infusion doses of AP214 in subjects having heart surgery such as coronary bypass graft and/or valve repair or replacement surgery. AP214, the investigational drug, is being developed to potentially prevent post-surgical kidney injury after thoracic aortic aneurysm repair.
Reiki is an energy-based healing therapy using light touch. Manual therapy is a technique using light effleurage. These complimentary healing services are utilized to promote relaxation, sleep, improve emotions, and decrease pain; however, more research is required since sample sizes in the literature were small, subjects were generally healthy (not hospitalized), and subjects had multiple medical backgrounds. Only 1 study focused on cardiac surgery patients. We aim to learn if Reiki and manual therapy enhances postoperative clinical outcomes for patients after first time coronary artery bypass graft (CABG) and/or cardiac valve surgery. A randomized, controlled non-blinded study will enroll a sample of a minimum of 272 patient (136 per group), based on a power analysis using the primary outcome. The intervention group will receive usual care plus Reiki and manual therapy, with Reiki delivered first. Total therapies time is 20 minutes. Reiki and manual therapy will be delivered for 3 consecutive days beginning on the day after endotracheal tube removal. The usual care group will receive 20 minutes of uninterrupted rest, which is part of usual postoperative care. Outcomes are depression, anxiety, pain, night time sleep, new onset atrial fibrillation, hospital length of stay, all-cause 30-day hospital readmissions, narcotic drug burden and post-operative complications.
ARB-PMCF is a multicenter, observational study of the safety and performance of Abbott annuloplasty devices used in surgical repair of mitral and tricuspid valve regurgitation. The devices included in this study are the SJM™ Rigid Saddle Ring and SJM Séguin Annuloplasty Ring, indicated for mitral valve repair, and the SJM Tailor™ Annuloplasty Ring and SJM Tailor Annuloplasty Band, indicated for mitral or tricuspid repair. Participants will be enrolled prior to undergoing mitral or tricuspid valve repair surgery including an Abbott annuloplasty implant and will complete annual follow-up visits through five years from implant. The study is being conducted to meet post-market clinical follow-up requirements of the European Union Medical Device Directives.
The investigators are interested in determining the best surgical technique to correct functional mitral regurgitation, as there is currently not one technique that is established to work better than the other. The technique used in current clinical practice is undersizing mitral annuloplasty (UMA), in which a prosthetic ring is implanted onto the mitral valve to correct the leakage. Though widely adopted, durability of the repair is less, as 58% of the patients present with recurrent FMR within 2 years. There are no specific algorithms to predict who might have UMA failure, but research indicates that some geometric indices might be strong predictors. The investigators are interested in testing the hypothesis that, elevated lateral inter-papillary muscle separation (IPMS) is a predictor of post-UMA recurrence of FMR at 12 months. In the first part of this study, the study team will measure lateral IPMS before surgery and relate to post-surgery FMR severity at discharge/30 days, 6 months and 12 months. A relatively newer technique is papillary muscle approximation (PMA), in which a suture draws together the two muscles that connect the mitral valve to the heart muscle prior to performing UMA. This reduces the lateral inter-papillary muscle separation (IPMS) and is expected to improve the durability of UMA. In the second part of this study, the investigators will perform PMA and UMA together and determine if FMR severity is reduced at discharge/30 days, 6 months and 12 months.
The use of a modified depolarizing cardioplegia solution in adult cardiac surgery would allow for prolonged re-dosing intervals while providing equivalent myocardial protection. The use of del Nido solution has been used extensively in congenital heart surgery for over 25 years. The primary objective is to determine whether expanding this technique to adult cardiac surgery will confer significant benefits in both surgical workflow and patient clinical outcome. The investigators hypotheses with regard to the del Nido solution will demonstrate (1) a non-inferior delivery to the current blood-based cardioplegia strategy in functional recovery or clinical outcome, and (2) superior delivery to the current blood-based cardioplegia strategy in cost analyses.
The purpose of this study is to evaluate the safety and initial performance of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System.
The purpose of this study is to compare the therapeutic strategies of rate control versus rhythm control in cardiac surgery patients who develop in-hospital postoperative atrial fibrillation or atrial flutter (AF). In patients who develop AF during hospitalization after cardiac surgery, the hypothesis is that a strategy of rhythm control will reduce days in hospital within 60 days of the occurrence of AF compared to a strategy of rate control.
The objective of this study is to show that ranolazine is a safe, viable and potent alternative for post-operative atrial fibrillation suppression in patients undergoing cardiac surgery
The purpose of this study tests whether beta-blocker will benefit asymptomatic patients with chronic primary mitral regurgitation.
To determine whether ranibizumab therapy before and after tube insertion for glaucoma surgeries can maintain the patency of the tube and prevent scar formation, and increase the chances for a successful procedure compared to observation.
The purpose of this study is to demonstrate faster time to extubation after arrival in the cardiothoracic intensive care unit (ICU) in patients undergoing isolated coronary artery bypass grafting (CABG), AVR and AVR/CABG combination who receive Sugammadex as compared to placebo.
To assess the safety and effectiveness of the SAPIEN XT transcatheter heart valve in patients with a failing surgical aortic bioprosthetic valve.
This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.
The purpose of this study is to evaluate the efficacy and safety of dexmedetomidine in the prevention of postoperative delirium in subjects undergoing heart valve surgery with or without coronary artery bypass surgery (CABG) using cardiopulmonary bypass (CPB).
This is a prospective, randomized pilot study in patients undergoing Sugical Aortic Valve Replacement (SAVR) and Transcatheter Aortic Valve Replacement (TAVR) to estimate the incidence of reduced leaflet motion and assess the impact of perioperative anticoagulation on the incidence of reduced leaflet motion.
The purpose of the clinical study is to prove that the heart valve device is safe, effective, and performs as intended.