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Aortic Valve Stenosis clinical trials

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NCT ID: NCT03470246 Recruiting - Clinical trials for Coronary Artery Disease

Personalized Activity Intervention in Rehabilitation After Cardiac Operations (the PACO Trial)

PACO
Start date: April 6, 2018
Phase: N/A
Study type: Interventional

The PACO trial is a randomized clinical trial conducted in Heart Centers of Kuopio and Turku university hospitals. The coronary artery disease, aortic valve stenosis and mitral valve insufficiency patients preparing for elective coronary artery bypass grafting (CABG), aortic valve replacement (AVR) or mitral valve repair (MVR) will be randomized to either intervention or control group. The specific operation groups (CABG, AVR and MVR) will be analyzed separately. The 7-day baseline measurements of sedentary behaviour (SB), physical activity (PA) and sleep will be conducted to the patients by using the RM42 accelerometer during the pre-operative month. After the cardiac procedure is completed and the patient is moved to post-operative ward, the control group patients will begin the standard post-operative rehabilitation program of the participating hospitals (activity guidance given by a physiotherapist). Patients in the intervention groups will follow the identical program but after discharge they will also receive personalized activity guidance through the combination of ExSed smart phone application, Suunto MoveSense accelerometer and cloud system during the first 90 days of post-operative rehabilitation. Weekly evolving daily goals to replace SB with PA (daily goals for steps, moderate PA, light PA and standing, and sitting time limit) will be designed for each patient of the intervention groups. A new daily step goal will be delivered from the cloud system to the patient's smart phone in the beginning of each week of the intervention. The daily step goal of the first intervention week is based on patient's walking distance assessed by a physiotherapist in post-operative ward. The following goals will be automatically evolved in the basis of patient's personal average step count of the previous week. The MoveSense accelerometer will measure accumulated levels of SB, PA and sleep, and transmit the data to user's ExSed application with Bluetooth. With information about accumulated levels of SB and PA, the application is able to guide the patient to accomplish the predefined activity goal. The guidance and motivation will be offered with pop-up notifications and histograms (columns are fulfilled according to patient's accumulated daily activity). The researches retain a remote access to the activity data of patients in the cloud system. The ExSed application will be connected to the cloud system with internet connection. In addition, the patients of the intervention groups will receive short video files (lasting from 1 to 3 minutes) containing exercise guidance from a physiotherapist specialized to cardiac operation patients. These videos are available on the ExSed application during the intervention. The physiotherapist will also contact each patient (by mobile phone) with structured contact form from 1 to 4 times in a month to make sure that the intervention is proceeding as designed.

NCT ID: NCT03453567 Recruiting - Clinical trials for Aortic Valve Stenosis

Evaluation of Effectiveness and Safety of Aortic Valve Replacement in Routine Clinical Practice

IRIS AVR
Start date: May 10, 2018
Phase:
Study type: Observational

This study evaluated effectiveness and safety of aortic valve replacement in real-world clinical practice.

NCT ID: NCT03385785 Recruiting - Clinical trials for Aortic Valve Stenosis

Ventriculo-arterial Coupling Modification Evaluated by PRAM During TAVI Procedure

PRAM-TAVI
Start date: September 14, 2017
Phase: N/A
Study type: Observational [Patient Registry]

Calcified aortic stenosis is the most frequent valvulopathy in Europe and North America. Aortic stenosis is an obstacle to the ejection of blood from the left ventricle to the aorta and leads to morphological changes in the left ventricle and hemodynamic modifications. Intrinsic ventricular performance can be characterized using three parameters: - Ventricular elastance (Ees for End Systolic Elastance) which represents the index of ventricular contractility independently of the load. - Arterial elastance (Ea for Arterial Elastance) which represents the post-load - The ventriculo-arterial coupling index (Ees / Ea) which represents energy efficiency. For patients with high surgical risk (EuroSCORE II> 6), TAVI (Transcatheter Aortic Valve Implantation) is recommended for aortic valve replacement. Many complications may occur after TAVI (haemorrhagic, embolic, renal, myocardial ischemia). Post-TAVI complications may also be cardiac decompensation of the underlying cardiac disease to cardiogenic shock. However, literature on left ventricular performance after aortic valvular replacement is poor because of the difficulty and invasiveness of the analysis involved. Cardiac energy analysis plays an additional role in understanding the clinical patients conditions. On this point, cardiac energy modifications, based on ventriculo-arterial coupling, could be indicators of cardiac function. Two methods (ultrasound and pulse contour) are used to understand and explore the ventriculo-arterial coupling, preload, postload, contractility and hemodynamic changes interactions. Echocardiography allows the Ees / Ea and SW / PVA (Stoke work/ pressure-volume area) ratios mesurements. PRAM (Pressure Recording Analytical Method) through the MostCare® monitor, gives common hemodynamic parameters and more specific parameters such as arterial elastance (Ea) cardiac cycle efficiency (CCE), dP / dt. Cardiac cycle efficiency (CCE) is an exclusive variable that describes the hemodynamic performance in terms of energy expenditure in the patient being followed. TAVI procedure is an acute model of ventriculo-arterial coupling modification by treatment of the ventricular ejection obstacle. The PRAM method evaluates the ventriculo-arterial coupling. The aim of our study is to evaluate by PRAM the changes in cardiac energy variables before and after aortic valve replacement by TAVI

NCT ID: NCT03361046 Recruiting - Clinical trials for Aortic Valve Stenosis

Polish Transcatheter Aortic Valve-in-Valve Implantation (ViV-TAVI) Registry

Start date: January 1, 2018
Phase:
Study type: Observational

In the past years a substantial shift away from mechanical heart valves occurred and bioprosthetic heart valves claimed majority of market shares irrespective of patients' age.This indicates that population with failed surgical bioprostheses requiring ViV-TAVI will grow significantly and therefore, meticulous prospective data collection is necessary for future analyses in order to better understand potential limitations of this procedure.

NCT ID: NCT03361007 Recruiting - Clinical trials for Aortic Valve Stenosis

Polish Registry of Common Carotid Artery Access for TAVI

POL-CAROTID
Start date: January 1, 2018
Phase:
Study type: Observational [Patient Registry]

Transcatheter aortic valve implantation (TAVI) is valuable treatment option for patients, who are at the high risk of surgical aortic valve replacement (AVR). Majority of procedures are performed through femoral arteries, however in some this access cannot be applied. Common carotid artery is one of the alternative routes of delivering the device in those patients. Established registry aims at collecting the data prospectively to assess outcomes of TAVI through common carotid artery.

NCT ID: NCT03360591 Recruiting - Clinical trials for Coronary Artery Disease

Functional Assessment In TAVI: FAITAVI

FAITAVI
Start date: November 24, 2017
Phase: N/A
Study type: Interventional

The aim of this study is to compare the clinical outcome of patients with severe aortic valve stenosis and associated significant coronary artery disease treated with TAVI and a percutaneous myocardial revascularization dictated according to two different strategies: 1. the Angiographically-guided strategy; 2. the Physiologically-guided strategy.

NCT ID: NCT03341169 Recruiting - Clinical trials for Aortic Valve Stenois

Impact of Perioperative Treatment With Intravenous Glutamine on Myocardial Protection in Cardiac Surgery Patients With Aortic Stenosis

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

The purpose of this study is to confirm if myocardial protection effect can be obtained by intravenous administration of glutamine in patients undergoing aortic valve replacement with severe aortic stenosis (who are at high risk for ischemia-reperfusion injury). As a prospective double blinded randomized placebo-controlled trial, the investigators detect and compare the degree of myocardial damage(with CK-MB and Troponin T) and myocardial protection (through hsp 70 expression in atrial tissue), cardiovascular index, inflammatory reaction, and clinical manifestation.

NCT ID: NCT03310671 Recruiting - Aortic Stenosis Clinical Trials

Aortic Stenosis in Subjects With Heterozygous Familial Hypercholesterolemia on Prolonged Treatment With Statins

Start date: July 18, 2017
Phase: N/A
Study type: Observational [Patient Registry]

Aortic stenosis (AE) is a disease that has been increasing steadily in recent years in most countries, including Spain.Risk factors for the development of AE include age, hypercholesterolemia, diabetes mellitus and arterial hypertension, the classic risk factors for the development of atherosclerosis. However, lipid-lowering therapy with statins and ezetimibe has not been shown to reduce the risk of long-term progression of AE by unknown mechanisms. All this suggests that subjects with HFhe have a high risk of developing AD, which has not been shown by the high coronary mortality in this population that precedes aortic calcification

NCT ID: NCT03303612 Recruiting - Clinical trials for Aortic Valve Stenosis

Clinical Monitoring Strategy Versus Electrophysiology-guided Algorithmic Approach With a New LBBB After TAVI

COME-TAVI
Start date: October 15, 2017
Phase: N/A
Study type: Interventional

The primary hypothesis of the proposed study is that an electrophysiology-based algorithmic approach is superior to standard clinical follow-up with 30-day monitoring in reducing the combined endpoint of syncope, hospitalization, and death in patients in patients with new of left bundle branch block following transcatheter aortic valve implantation (TAVI).

NCT ID: NCT03298178 Recruiting - Clinical trials for Aortic Valve Stenosis

ASAN Medical Center Aortic Valve Replacement Registry

ASAN-AVR
Start date: December 1, 2017
Phase:
Study type: Observational

This study evaluates the effectiveness and safety of surgical aortic valve replacement and transcatheter aortic valve replacement in aortic Stenosis.