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Heart Valve Diseases clinical trials

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NCT ID: NCT02572999 Completed - Iatrogenic Disease Clinical Trials

Incidence and Risk Factors for Hospitalization-Associated Disability

Start date: October 2015
Phase: N/A
Study type: Observational

This prospective cohort study aims to determine the incidence of hospitalization-associated disability and its association with risk factors at the patient level and with care and hospital processes. For this, patients aged 70 years or older admitted for elective valve surgery or elective transcatheter aortic valve implantation or as a result of symptomatic moderate to severe valvular heart disease will be consecutively included from 01 October 2015 to 29 February 2016.

NCT ID: NCT02527629 Completed - Heart Valve Disease Clinical Trials

Aortic Replacement Using Individualised Regenerative Allografts - ARISE (the "Surveillance")

ARISE
Start date: September 2015
Phase:
Study type: Observational

Evaluation of decellularized human heart valves for aortic heart valve replacement in comparison to current valve substitutes. Safety endpoints include cardiovascular adverse events, time to re-operation, re-intervention and explantation. Efficacy endpoints include freedom from valve dysfunction and hemodynamic performance.

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: NCT02394184 Completed - Clinical trials for Cardiovascular Diseases

The Bicuspid Aortic Stenosis Following Transcatheter Aortic Valve Replacement Registry

Bicuspid TAVR
Start date: May 2015
Phase:
Study type: Observational

The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve stenosis.

NCT ID: NCT02371863 Completed - Clinical trials for Heart Valve Diseases

Normal Values in Stress Echocardiographic Parameters in Patients After Successful Mitral Valve Repair for Organic MR

SEP
Start date: December 2014
Phase: N/A
Study type: Observational

Surgical treatment is the only approach with potentially defined clinical success for organic mitral valve (MV) regurgitation. Recurrent or persistent complaints after initial successful MV repair is a clinical challenge in current practice. Especially when echo parameters at rest are within or near normal ranges and patients presenting disproportionately symptomatic in relation to the observed results. However, while MV regurgitation is a hemodynamic disease, currently used 2-dimensional (2D) transthoracic echocardiography (TTE) at rest lacks information about hemodynamic changes. Physical stress echocardiography is a promising technique to complement nowadays rest TTE in order to improve interpretation of hemodynamic changes. However, normal values for exercise echo are lacking in this postoperative patients cohort. A prospective, observational trial to determine normal values in stress echocardiographic parameters in asymptomatic patients after successful MV repair for organic MV regurgitation, is therefore highly needed. Purpose of the SEP- study is to determine normal values in stress echocardiographic parameters in asymptomatic patients at least 6 months after successful MV repair for organic MV regurgitation. These normal values for stress echo are of utmost importance to correctly and accurate interpret stress echo results during postoperative follow-up and to improve clinical decision making in patients post MV repair.

NCT ID: NCT02370511 Completed - Clinical trials for Mitral Valve Disease

Mitral Implantation of TRAnscatheter vaLves

MITRAL
Start date: February 25, 2015
Phase: N/A
Study type: Interventional

The purpose of this trial is to establish the safety and feasibility of the Edwards SAPIEN XT™and SAPIEN 3™ device and delivery systems in patients with severe symptomatic calcific mitral valve disease with severe mitral annular calcification who are not candidates for standard mitral valve surgery.

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: NCT02297334 Completed - Clinical trials for Coronary Artery Disease

Removal of Cytokines During Extracorporeal Circulation in Cardiac Surgery

Start date: September 2013
Phase: N/A
Study type: Interventional

The aim of this study is to prove that using a CytoSorb(TM) filter in the cardiopulmonary circuit attenuates the inflammatory response to extracorporeal circulation in patients undergoing cardiac surgery. The hypothesis is that removing cytokines from patients' blood by the CytoSorb device significantly improves circulation and outcome in patients undergoing on-pump cardiac surgery.

NCT ID: NCT02278835 Completed - Clinical trials for Mitral Valve Disease

The Effectiveness of Respiratory Physiotherapy in Mitral Valve Surgery

Start date: March 2009
Phase: N/A
Study type: Interventional

This trial was conducted to evaluate the effectiveness of the chest physiotherapy techniques to prevent pulmonary collapse based in an score applied in the patients submitted of the mitral valve surgery, after their ICU discharge. Patients were allocated in groups according their pulmonary function (FVC: forced vital capacity), the respiratory muscle performance (MIP: maximal inspiratory pressure; MEP: maximal expiratory pressure), the oxygenation level (SpO2), the pulmonary auscultation; respiratory frequency (f); the ability to expectorate and the functional independence. The group I was allocated those patients which presented decrease of up to 50% of forced vital capacity (FVC) of preoperative period, SpO2>92%, minimal pulmonary auscultation alterations; frequency (f) between 15 and 25 ipm; able to expectorate without assistance; independence to sit; respiratory. In these patients were randomized for two interventions: a) Deep breathing exercises: diaphragmatic exercises; inspiratory sighs; maximal inspiration exercises. Each kind of exercises was repeated 10 times; b) volume-targeted incentive spirometer: used Coach® three sets of 10 repetitions. Patients allocated in the group II presented FVC> 30% <49% of preoperative period, ≥ 88% SpO2 <92%, necessity of oxygen therapy, abnormal pulmonary auscultation, f> 25 <31ipm; dependence to expectorate and to sit.. They were assisted by: a) Intermittent Positive Pressure Breathing (IPPB) with PEEP - through ventilator (Bird Mark 7™) with exhalation valve spring load set at 10 cmH2O. b) CPAP - 10 cmH2O associated with oxygen support to obtain SpO2≥ 95% with electronic device (Sullivan®) Each session consisted of 20 minutes, twice daily, one in the morning and another in the afternoon. All of the patients were conducted in effort to mobilize upper and lower limbs. On the first day, the patients walked at least 50 meters, by increasing the distance to at least 150 meters on the fourth day. Outcome measures were recorded at day 5 of the interventions.