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Heart Valve Diseases clinical trials

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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: NCT02867930 Completed - Heart Valve Disease Clinical Trials

Comparative Effects of Dexmedetomidine and Ketofol for Sedation in Patients Undergoing Trans-esophageal Echocardiography

KDTEE
Start date: June 2016
Phase: Phase 4
Study type: Interventional

The purpose of the study is to compare dexmedetomidine and ketofol to find a suitable alternative for moderate sedation in out-patient diagnostic trans-esophageal echocardiography.

NCT ID: NCT02865798 Not yet recruiting - Clinical trials for Heart Valve Diseases

China Senile Valvular Heart Disease Cohort Study

Start date: September 2016
Phase: N/A
Study type: Observational

Valvular heart diseases (VHD) are the most common causes of mortality and morbidity after coronary artery disease, hypertension, and heart failure, especially in senile patients who have more comorbidities and often require intervention. The prevalence of senile VHD is increased gradually as the growth of the age. In addition important changes have occurred as regards the presentation and treatment of the disease over recent years. However, there is little information about senile VHD in China. The purposes of this study are to evaluate the clinical characteristics, reasons for hospitalization, risk stratification, treatment modalities, quality of life and outcomes of senile hospitalized patients with VHD, to determine the risk factors affecting the prognosis, further to lay the foundation for establishing a prognosis model suitable for Chinese senile VHD.

NCT ID: NCT02833948 Completed - Clinical trials for Cardiovascular Diseases

Comparison of a Rivaroxaban-based Strategy With an Antiplatelet-based Strategy Following Successful TAVR for the Prevention of Leaflet Thickening and Reduced Leaflet Motion as Evaluated by Four-dimensional, Volume-rendered Computed Tomography (4DCT)

GALILEO-4D
Start date: May 2016
Phase: Phase 3
Study type: Interventional

The aortic valve is located between the left ventricle and the aorta. Patients with symptomatic, severe aortic valve stenosis conventionally have it surgically replaced requiring direct access to the heart through the chest. Transcatheter aortic valve replacement (TAVR) is now a well-established alternative for treating severe aortic valve stenosis. Both types of intervention improve prognosis and alleviate symptoms. The optimal choice of blood thinning therapy after TAVR is unknown. It has been reported that leaflet thrombosis with reduced leaflet motion can occur and this phenomenon has been suggested to be potentially related with neurological events. In addition, the occurence of this phenomenon can be reduced with anticoagulation blood thinning therapy. The purpose of this study is to evaluate if anticoagulation compared to the usual double platelet inhibitor therapy after TAVR can reduce the risk of leaflet thrombosis.

NCT ID: NCT02825134 Active, not recruiting - Clinical trials for Cardiovascular Diseases

Comparison of TAVR With SAVR in Younger Low Surgical Risk Patients With Severe Aortic Stenosis

NOTION-2
Start date: June 30, 2016
Phase: N/A
Study type: Interventional

A randomized clinical trial investigating transcatheter (TAVR) versus surgical (SAVR) aortic valve replacement in patients 75 years of age or younger suffering from severe aortic valve stenosis. Study hypothesis: The clinical outcome (death of any cause, stroke and rehospitalization (related to the procedure, valve or heart failure)) obtained within one year after TAVR is non-inferior to SAVR.

NCT ID: NCT02818959 Terminated - Clinical trials for Cardiovascular Diseases

First in Man Study of the JenaValve TAVI Plus System Transfemoral

CP-0001
Start date: December 2013
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate feasibility, safety and effectiveness of the first generation transfemoral JenaValve Pericardial TAVR System (formerly named JenaValve TAVI Plus System- Transfemoral) in an elderly patient population with severe aortic stenosis who are at high risk for surgical aortic valve replacement.

NCT ID: NCT02806310 Completed - Clinical trials for Aortic Valve Disease

Podocan and Wnt Pathway in the Development of Aortopathy in Bicuspid Valve Disease

Start date: June 2016
Phase:
Study type: Observational [Patient Registry]

Bicuspid Aortic Valve (BAV) disease is a common cardiac anomaly that is associated with valvular abnormalities, both stenosis and regurgitation, and aortopathy. It is also shown to play role in abnormal aortic distensibility and stiffness with impairment of aortic elasticity and Left ventricular dysfunction. Mechanism of aortopathy is complex and is not understood completely. In a recent study podocan is found in extracellular matrix (ECM) of human aorta and is found to be accumulated in human abdominal aortic aneurysms. There is no current effective therapy that can alter the progression of aortic dilatation in bicuspid valve disease. Aortic surgery and aortoplasty is the only treatment in severely dilated aorta and aortic dissection. In this study the aim is to investigate the association between podocan and Wnt pathway in development and pathogenesis of aortopathy. This could provide more effective and physiological understanding of disease process and potential target in prevention and treatment for aortopathy.

NCT ID: NCT02790008 Completed - Fibrosis Clinical Trials

Magnetic Resonance Imaging and Fibrosis

MRF
Start date: June 2015
Phase:
Study type: Observational

Aortic valve disease causes impaired let ventricular function (LVF) due to hypertrophy, dilatation and diffuse myocardial fibrosis yet the prognostic effect of fibrosis, waiting time for operation and postoperative exercise training is presently unknown. The investigators aim to (1) determine the changes in LVF for patients on the waiting list; (2) establish non-invasive diagnostics for diffuse myocardial fibrosis; (3) relate LVF to fibrosis and physical capacity. The unique design (echocardiography, cardiopulmonary exercise test, cardiac magnetic resonance tomography and myocardial biopsy on the same patients) makes it possible to establish relationship between results of histology and imaging; quantifying and qualifying fibrosis in vivo, evaluate LVF vs. general cardiopulmonary function and optimize health care prior to and after operation.

NCT ID: NCT02775123 Completed - Myocardial Ischemia Clinical Trials

Cytokine Clearance With Cytoabsorbant Device During Cardiac Bypass

CCCC
Start date: May 2016
Phase: Phase 1/Phase 2
Study type: Interventional

Investigators are planning a single center pilot randomized controlled trial to assess the potential of a Cytoadsorbant filter (Cytosorb®, Germany) to remove cytokines from the blood during cardiac surgery. Investigators will screen all patients undergoing cardiac surgery and approach those deemed at risk of post surgical complications [≥ 1 among: age >75 years old, double valvular replacement, complex surgery with expected CPB time >100 min, redo cardiac surgery, pre-op chronic renal failure (plasma creatinine level >120 mcmol/l) or chronic heart failure (LVEF <35%)]. Patients with end-stage renal disease (dialysis dependence), undergoing an emergency procedure or an off-pump procedure, those who decline informed consent as well as those enrolled in another conflicting study will be excluded. Eligible patients will be approached, consented and enrolled in the trial. Patients will then be randomized to either receive conventional CPB (control arm) or CPB plus Cytosorb (intervention arm). The target population is 30 patients (15 per arm). For this pilot study, investigators main outcome will be differences between the two arms in measurement of serum levels for IL-2, IL-6, IL-10 and TNF alpha at baseline (pre-operatively), on ICU admission, as well as 6 and 24 hrs post CPB. Secondary outcomes will be changes in coagulation factors serum levels, the need for vasopressors, inotropes, mechanical ventilation and renal replacement therapy, ICU and hospital length of stay as well as in-hospital mortality. Recruitment period should span from May 2016 to April 2017.

NCT ID: NCT02764645 Not yet recruiting - Clinical trials for Coronary Artery Disease

Performance of the CARDIOGARD Cannula

GECG
Start date: May 2016
Phase: N/A
Study type: Interventional

This is a single center, prospective study: The 'CardioGard Cannula' Gaseous emboli capture results - shows an improvement from the control group.