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Aortic Stenosis clinical trials

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NCT ID: NCT02174471 Completed - Aortic Stenosis Clinical Trials

Regression of Myocardial Fibrosis After Aortic Valve Replacement

RELIEF-AS
Start date: October 2012
Phase: N/A
Study type: Observational

Aortic stenosis (AS) is the most common valvular heart condition in the United Kingdom and the Western world. Surgery for severe AS prior to symptom onset is controversial. Conventionally changes in valve area and gradient are used to time intervention but myocardial changes may be more predictive of surgical need. This study aims to elucidate the role of diffuse myocardial fibrosis as a prognostic marker, implementing a novel, non-invasive MRI technique to measure it. Design: The investigators will measure diffuse myocardial fibrosis in 150 patients with severe narrowing of the aortic valve before and one year after valve replacement. Expected outcomes: Diffuse myocardial fibrosis measured by MRI scanning will predict outcome after surgery in aortic stenosis. Anticipated Health Benefits: Identify patients with higher post operative morbidity and mortality, who may benefit from earlier valve replacement.

NCT ID: NCT02146768 Completed - Aortic Stenosis Clinical Trials

Low-dose-contrast Cardiac Computed Tomography

CCTA
Start date: January 2014
Phase: N/A
Study type: Observational

Low-dose-contrast CCTA can effectively and safely assess the aortic valve apparatus, and effectively direct the trans-catheter heart valve (THV) size selection by providing accurate annulus sizing, and provide adequate pre-procedural risk-stratification guidance for TAVR/TAVI.

NCT ID: NCT02122900 Completed - Aortic Stenosis Clinical Trials

Prospective Balloon Aortic Valvuloplasty

BAV
Start date: June 2013
Phase: N/A
Study type: Observational

The primary objective of this study is to determine the reasons for balloon aortic valvuloplasty (BAV) in the current clinical setting and to determine the outcomes of BAV in patients with aortic stenosis. The ultimate aim is to establish the safety, effectiveness, and appropriate role of BAV therapy as definitive therapy (palliation) or as a "bridge" to surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR).

NCT ID: NCT02101619 Completed - Aortic Stenosis Clinical Trials

Assessment of Myocardial Tissue Damage in Aortic Stenosis

Start date: August 2013
Phase: N/A
Study type: Observational

Aortic stenosis (AS) is the most common valve disease in the United States and most common indication for valve replacement surgery. Anatomical and hemodynamic severity of AS is insufficient for elucidating patients' prognosis. Therefore, the decision about the optimal timing of surgical intervention remains critical. However, the changes in structure and electrical activity of the cardiac muscle can be assessed by noninvasive imaging and electrocardiography (ECG). Degenerative myocardial changes characterized by fibrosis or collagen deposits are frequently observed in AS patients and have a negative impact on patient outcomes. In this project, our objective is to determine whether echocardiographic image analysis of integrated backscatter (IB), which can express changes in myocardial tissue composition (amount of fibrosis) based on its ultrasound reflectivity, global left ventricular (LV) load as measured by Zva, and ECG analysis of the duration of the QRS interval have a role in risk stratification for AS patients and to apply those methods to identify which patients would benefit from surgical intervention. The investigators hypothesize that 1) the severity of myocardial damage can discriminate the prognosis in patients with AS, and 2) IB, Zva, and QRS interval can be diagnostic measures of the severity of myocardial damage. The investigators will measure the severity of myocardial fibrosis using MRI (reference) in 50 patients and will test the diagnostic significance of IB (testing method). Zva, QRS duration, and conventional echocardiographic measures will also be tested for diagnosing severity of myocardial fibrosis.

NCT ID: NCT02089945 Completed - Aortic Stenosis Clinical Trials

Pilot Study of Cognitive and Functional Outcomes Following TAVI

Start date: February 2014
Phase: N/A
Study type: Observational

Narrowing of the aortic valve in the heart, known as severe aortic stenosis, can impede blood delivery and is associated with poor quality of life and death. In the elderly with considerable medical burden, a relatively new non-invasive valve replacement technique called Transcatheter Aortic Valve Implantation (TAVI) can be used instead of open-heart surgery. However, long term changes in cognition after TAVI remain unclear and previous studies have suggested an increased risk of cognitive decline in patients following the surgical procedure. In this pilot study, the investigators will characterize changes in cognition, physical capacity, overall quality of life and neuropsychiatric symptoms (depression and apathy) over 6 months after TAVI.

NCT ID: NCT02076711 Completed - Aortic Stenosis Clinical Trials

Myocardial Efficiency of the Left Ventricle in Asymptomatic Patients With Aortic Valve Stenosis - a Prognostic Marker and a Target for Intervention?

MELVAS
Start date: June 2013
Phase: Phase 2
Study type: Interventional

Background - Aortic valve stenosis (AS) is the most common heart valve disease among adults in the Western world with a prevalence of 3 % in people older than 75 years of age. AS usually deteriorates over time leading to heart failure, with high mortality if aortic valve replacement (AVR) is not performed. Thus optimal timing of AVR is crucial, but can be challenging. Increasing life expectancy in our society will augment the therapeutic and socio economic impact of AS disease on our health care system. Therefore, new techniques for monitoring asymptomatic AS patients are needed. A potential approach is monitoring of LV myocardial efficiency (mechanical work/oxygen consumption). These measures have been suggested to be involved in the progression of non-valvular heart failure and closely related to prognosis, but never applied in a larger population of patients with AS. At present there are no recognized pharmacological treatments of AS. It is known that beta-blocker treatment in non-valvular systolic heart failure reduce heart rate, improves LV myocardial efficiency and reduces mortality. However, in patients with AS, the effects of beta-blockers are unknown. Hypotheses - Treatment with the beta-blocker metoprolol succinate in patients with asymptomatic moderate to severe AS has beneficial effects on LV myocardial oxidative metabolism, myocardial efficiency and contractile function. Objectives - To investigate if beta-blocker treatment in patients with moderate to severe, asymptomatic AS has beneficial effects on LV myocardial efficiency, contractile function and physical performance. Design - A randomized double blind placebo controlled intervention trial. 40 patients with asymptomatic AS will be randomized to either per oral metoprolol succinate (N = 20) or placebo (N= 20) for 22 weeks. Primary objective - Changes in myocardial efficiency Secondary objectives - Myocardial oxygen consumption, Myocardial perfusion at rest, LV myocardial function, LVmass, Aortic valve area and transaortic valve velocities, 6 minute walking distance, N-terminal prohormone of brain natriuretic peptide, Quality of life (estimated by Minnesota living with heart failure questionnaire), LV wall stress Methods - Patients will undergo echocardiography (resting and exercise), [11C]acetate PET and cardiac magnetic resonance imaging.

NCT ID: NCT02073617 Completed - Clinical trials for Coronary Artery Disease

Aortic Valve and Root Measurements Under Real-Time 3-Dimensional Visualization During Angiography

Start date: January 6, 2014
Phase: N/A
Study type: Interventional

The American College of Cardiology/American Heart Association guidelines place symptomatic severe Aortic Stenosis as a class I indication for aortic valve replacement. With the recently approved Edwards-Sapien TAVR device and the ongoing investigations using the CoreValve TAVR device, patients ineligible or at high risk for open-heart surgery are now eligible to undergo TAVR. Patients selected for TAVR undergo an EKG-gated cardiac Multislice CTA to evaluate aortic valve anatomy and aortic root dimensions for device sizing, as well as coronary angiography to define coronary anatomy. Both tests utilize contrast media to visualize anatomy, which may result in contrast-induced nephropathy in anywhere from 7.5% to more than 50% of patients depending on associated clinical risk factors. There is a need to consolidate this pre-operative testing whenever possible, and with real-time 3-dimensional visualization of aortic valve and root anatomy using DynaCT cardiac acquisition in the cath lab angiography suite during the coronary angiography, there may be a benefit with reduced contrast load (20 to 35cc for DynaCT, 100cc for CTA). We would like to make a comparison of aortic valve and root measurements using CTA and DynaCT to affirm the accuracy of DynaCT vs the CTA gold standard.

NCT ID: NCT02053818 Completed - Aortic Stenosis Clinical Trials

Remifentanil/Sufentanil for CABG+/-AVR Evaluated by Recovery, Cognitive Function, Haemodynamics and Biochemical Markers.

PRECON2
Start date: August 2011
Phase: Phase 4
Study type: Interventional

To evaluate the effect on cognitive function, recovery, cardioprotection and haemodynamics of standard Remifentanil anaesthesia to standard Sufentanil anaesthesia in patients undergoing coronary artery bypass with or without aortic valve replacement.

NCT ID: NCT02005640 Completed - Aortic Stenosis Clinical Trials

Transcatheter Heart Valve (THV) Sizing and Leakage After Transcatheter Aortic Valve Implantation (TAVI) Before and After Establishing Routine Preprocedure Multi Slice Computerized Tomography (MSCT) Aortic Assessment. A Retrospective Registry Study

Start date: December 2011
Phase: N/A
Study type: Observational

The objective of this study is to evaluate the effect of annular sizing strategy (MDCT versus TEE) in transcatheter aortic valve implantation on the prevalence and severity of paravalvular regurgitation.

NCT ID: NCT01991431 Completed - Aortic Stenosis Clinical Trials

ROUTE Registry Of the Utilisation of the Transaortic (Tao) TAVI Approach Using the Edwards Sapien XT Valve

ROUTE
Start date: February 2013
Phase: N/A
Study type: Observational [Patient Registry]

This is an international multi-center, prospective, observational registry with consecutive patient enrollment intended to determine outcome Parameters within 30 days after transaortic transcatheter aortic valve replacement.