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Valvular Heart Disease clinical trials

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NCT ID: NCT03458806 Completed - Clinical trials for Aortic Valve Stenosis

Phono- and Electrocardiogram Assisted Detection of Valvular Disease

PEA-Valve
Start date: February 22, 2018
Phase:
Study type: Observational

The diagnosis of valvular heart disease (VHD), or its absence, invariably requires cardiac imaging. A familiar and inexpensive tool to assist in the diagnosis or exclusion of significant VHD could both expedite access to life-saving therapies and reduce the need for costly testing. The FDA-approved Eko Duo device consists of a digital stethoscope and a single-lead electrocardiogram (ECG), which wirelessly pairs with the Eko Mobile application to allow for simultaneous recording and visualization of phono- and electrocardiograms. These features uniquely situate this device to accumulate large sets of auscultatory data on patients both with and without VHD. In this study, the investigators seek to develop an automated system to identify VHD by phono- and electrocardiogram. Specifically, the investigators will attempt to develop machine learning algorithms to learn the phonocardiograms of patients with clinically important aortic stenosis (AS) or mitral regurgitation (MR), and then task the algorithms to identify subjects with clinically important VHD, as identified by a gold standard, from naïve phonocardiograms. The investigators anticipate that the study has the potential to revolutionize the diagnosis of VHD by providing a more accurate substitute to traditional auscultation.

NCT ID: NCT03366649 Completed - Clinical trials for Coronary Artery Disease

Improving Mitral Repair for Functional Mitral Regurgitation

IMPROVE-FMR
Start date: March 20, 2018
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03280745 Completed - Clinical trials for Cardiovascular Diseases

Hypertonic Saline for Fluid Resuscitation After Cardiac Surgery

HERACLES
Start date: February 27, 2018
Phase: Phase 4
Study type: Interventional

Background: Volume replacement strategies and type of fluid used in patients undergoing cardiac surgery have changed during the last years. Currently used crystalloid solutes have a variable composition and a major impact on organ function and outcome. Additionally critically ill patients are prone to fluid overload, which is despite common perception, not a benign occurrence as it is associated with prolonged ICU- and hospital length of stay and increased mortality rates. Fluid resuscitation using bolus or continuous infusion of hypertonic saline was used for more than thirty years. Only a few studies have been conducted so far, but they showed that infusion of hypertonic saline results in less volume administered, increased renal function less weight gain in critically ill patients when compared to other crystalloids. Aim: This preliminary randomized controlled double-blind study aims to identify whether fluid resuscitation using hypertonic saline (HS) when used in addition to lactated Ringers solution results in less total fluid amount administered in patients following cardiac surgery. Additionally we want to evaluate whether the use of hypertonic saline results less need for pharmacological cardiocirculatory support, increased renal function, less postoperative volume overload shortened post-cardiac bypass immune suppression and increased postoperative outcomes. Study intervention: At admission to the ICU patients will receive 5ml/kg body weight of 7.3% NaCl or 0.9% NaCl by infusion pump over 60 minutes. If necessary, fluid resuscitation will thereafter be performed with Ringer`s lactate to normalize peripheral perfusion and to allow weaning of vasopressors.

NCT ID: NCT03197051 Completed - Clinical trials for Valvular Heart Disease

Impact of Perioperative Shedding of the Endothelial Glycocalyx on the Incidence of Postoperative Acute Kidney Injury in Patients Undergoing Valvular Heart Surgery.

Start date: June 25, 2017
Phase:
Study type: Observational

Endothelial glycocalyx, the luminal structure of healthy vasculature, plays critical roles in regulation of inflammatory responses, vascular permeability, blood coagulation. It can be easily damaged by ischemia/reperfusion, hypoxemia, oxidative stress, endotoxin. Accordingly, the relationship between the shedding of endothelial glycocalyx and the prognosis of diseases such as diabetes mellitus, atherosclerosis, malignancy has been researched. In cases of cardiac surgery, patients cannot help but be exposed to ischemia/reperfusion, oxidative stress which can damage endothelial glycocalyx. In this research, the investigators would like to discover the impact of perioperative shedding of the endothelial glycocalyx on the incidence of postoperative acute kidney injury in patients undergoing valvular heart surgery.

NCT ID: NCT02898090 Completed - Atrial Fibrillation Clinical Trials

Development and Validation of Automated Indicators on the Appropriateness of Oral Anticoagulant Prescriptions

PACHA
Start date: April 28, 2018
Phase:
Study type: Observational

This research focuses on the development and validation of indicators on the appropriateness of oral anticoagulant prescriptions. The investigators want to propose transferable tools to other healthcare institutions to allow automated construction of indicators as part of a structured approach to improve future practices. The main objective of the study is to develop indicators on the appropriateness of oral anticoagulant prescriptions in adult medicine automated from the hospital information system and to assess their criterion validity.

NCT ID: NCT02727413 Completed - Clinical trials for Valvular Heart Disease

Inflammatory Mediator Profiles During Heart Valve Replacement Surgery

Remove-Pilot
Start date: June 2016
Phase:
Study type: Observational

The study aims at the comparative examination of pre-, intra- and post-operative release profiles of inflammatory and vasoactive mediators in patients undergoing heart valve surgery under cardiopulmonary bypass (CPB) due to either infectious endocarditis or degenerative valvular heart disease. Specific attention will focus on the distinction between mediator release associated with infection and that resulting from CPB. Concomitantly identification and characterization of infectious pathogens in the circulation and in valvular samples will be carried out, together with the search for resistance-coding transcripts.

NCT ID: NCT02490644 Completed - Clinical trials for Valvular Heart Disease

Role of High Mobility Group Box 1 as a Prognostic Biomarker in Patients Undergoing Valvular Heart Surgery

Start date: January 12, 2015
Phase:
Study type: Observational

One of the most important factor that affects the post op complication of the cardiac surgery is systemic inflammation. Valvular heart surgery requires cardiopulmonary bypass and cardioplegic arrest, which can arouse the ischemic/reperfusion injury causing myocardial damage and inflammatory response. These myocardial damage and inflammatory response can cause multi-organ failure or even death.

NCT ID: NCT02479581 Completed - Clinical trials for Valvular Heart Disease

The Safety and Efficacy of the Enhanced Recovery After Surgery(ERAS)Applied on Cardiac Surgery With Cardiopulmonary Bypass

ERAS
Start date: July 2015
Phase: Phase 2
Study type: Interventional

This study evaluates the enhanced recovery after surgery (ERAS) concept over conventional postoperative care in patients with heart valve disease undergoing cardiac surgery with cardiopulmonary bypass. Half of participants will adherence to the ERAS, while the other half will under the conventional postoperative care.

NCT ID: NCT02303795 Completed - Clinical trials for Valvular Heart Disease

RIvaroxaban for Valvular Heart diseasE and atRial Fibrillation Trial -RIVER Trial

Start date: August 2015
Phase: Phase 2
Study type: Interventional

RIvaroxaban for Valvular heart diseasE and atRial fibrillation trial (RIVER trial).

NCT ID: NCT02241109 Completed - Clinical trials for Aortic Valve Stenosis

Predicting Aortic Stenosis Progression by Measuring Serum Calcification Propensity

PASP
Start date: September 30, 2014
Phase: N/A
Study type: Interventional

Aortic stenosis is the most common valvular heart disease and an important public-health problem. Surgical or interventional aortic valve replacement are based on symptoms and measures of valvular and ventricular function using echocardiography.There is no uniform pattern of progression. Instead, marked differences not only between individuals, but also during the time course of the disease can be observed. Several prospective studies have been performed to enhance the predictability of disease behavior. Individually it is still prone to large errors and hard to predict aortic stenosis progression. Therefore, in patients with aortic sclerosis without severe stenosis, it is desirable to find a strong predictor of rapid disease progression. This would allow anticipating cardiovascular deterioration by identifying individuals at particular risk. Study Hypothesis In patients with aortic sclerosis, increased serum calcification propensity, as measured by the T50-Test, is related to the amount of stenosis progression in one year.