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Aortic Valve Stenosis clinical trials

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NCT ID: NCT04548726 Completed - Clinical trials for Aortic Valve Stenosis

Hemodynamic Matched Comparison of the Balloon-Expandable Transcatheter Heart Valves Myval and Sapien-3 for the Treatment of Aortic Stenosis

MATCH-BALL
Start date: June 1, 2018
Phase:
Study type: Observational

Transcatheter aortic valve implantation (TAVI) is recommended for patients with severe aortic stenosis (AS) at high to intermediate surgical risk. Despite similar mortality rates compared to surgical aortic valve replacement (SAVR) in this setting, the rate para-valvular leak (PVL) remains higher and has been associated to higher mortality even at mild degree. This is one of the major concerns to extend TAVI to low surgical risk, although the favorable results from PARTNER 3. The presence of moderate to severe PVL after TAVI is associated to a 2- and 3- fold increase in the mortality rate at 30-day and 1-year follow-up, respectively (24-29). Prosthesis-patient mismatch (PPM) adversely affects functional improvement and exercise tolerance, left ventricular (LV) mass regression, and late structural valve deterioration. Many studies have previously investigated PPM after surgical AVR suggesting the presence of this problem in more than 40% of the surgically treated patients. This rate was significantly lower with the balloon-expandable Sapien (Edwards Lifesciences, Irvine, California), with PPM that varied from 8% to 18%, but in both cases (patients harboring TAVI and those with SAVR) the mortality rate was higher in the presence of PPM. Under the hypothesis that there are differences in terms of transvalvular gradients and residual para-valvular leak amongst different balloon-expandable TAVI devices available in the market, the aim of the MATCH-BALL study is to compare the hemodynamic performance of two balloon-expandable TAVI devices, Sapien 3 (Edwards Lifesciences, Irvine, CA, USA) and Myval (Meril Life Sciences Pvt. Ltd., India).

NCT ID: NCT04527367 Completed - Clinical trials for Coronary Artery Disease

Epidemiology and Long-term Outcome of Patients With VHD

BIA-WAD
Start date: January 2006
Phase:
Study type: Observational

Valvular heart diseases are significant problem in Polish population. Coexistence of coronary artery disease in patients with VHD increases the risk of death and affects further therapeutic strategy. The aim of the study is analysis the epidemiology and the long-term prognosis among patients with VHD.

NCT ID: NCT04503655 Completed - Clinical trials for Cardiovascular Diseases

Multicenter Study Evaluating the Efficacy of an Intervention Aimed at Reducing the Length of Stay After Transfemoral Transcatheter Aortic Valve Implantation

FAST-TAVI II
Start date: December 16, 2020
Phase: N/A
Study type: Interventional

Since the first implantation of a percutaneous aortic bioprosthesis (TAVI) in 2002 (Cribier et al. Circulation 2002), TAVI occupies an increasing place in the management of aortic stenosis (AR) . Initially reserved for inoperable patients at high surgical risk, TAVI is also recommended in patients at intermediate risk, especially when a femoral approach (TF) is possible (Baumgartner et al. Eur Heart J. 2017). Currently, there is no recommendation regarding length of stay after TAVI and practices are extremely heterogeneous. Despite the growing experience of centers, better patient selection and a reduction in complications, the length of stay after TAVI remains very high in France. Faced with the great disparity observed between the centers, efforts are necessary to educate the centers in order to further reduce the length of stay after TF-TAVI. The aim of the study is to evaluate the effectiveness of an intervention based on training teams to reduce the length of stay after TF-TAVI.

NCT ID: NCT04496297 Completed - Aortic Stenosis Clinical Trials

Non-contrast 3-dimensional Cardiac Magnetic Resonance Imaging

Start date: December 2013
Phase:
Study type: Observational

Non-contrast enhanced cardiac MRI using 3D whole heart acquisition protocol is non-inferior to contrast enhanced CT in the assessment of aortic annulus complex for pre-TAVR imaging.

NCT ID: NCT04489095 Completed - Aortic Stenosis Clinical Trials

Conduction Disease After Transcatheter Aortic Valve Replacement

Start date: July 16, 2020
Phase: N/A
Study type: Interventional

This is a prospective single center Cardiology department observational study. The study aim is to better understand the predictors of high grade conduction abnormalities associated with TAVR such that a more robust evidence-based and universal strategy to manage cardiac conduction disturbances in these patients, which has been elusive, can be developed.

NCT ID: NCT04459208 Completed - Clinical trials for Aortic Valve Stenosis

Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure During Transfemoral Transcatheter Aortic Valve Implantation

CHOICE-CLOSURE
Start date: June 26, 2020
Phase: N/A
Study type: Interventional

The aim of the study is to evaluate the clinical efficacy of 2 different vascular closure device (VCD) strategies during transfemoral transcatheter aortic valve implantation (TAVI). The study hypothesizes that the choice of one over the other VCD in patients undergoing transfemoral TAVI may demonstrate relevant differences in the rate of peri-procedural complications and effectiveness of vascular closure.

NCT ID: NCT04437303 Completed - Stroke Clinical Trials

Periprocedural Continuation Versus Interruption of Oral Anticoagulant Drugs During Transcatheter Aortic Valve Implantation (POPular PAUSE TAVI)

Start date: November 25, 2020
Phase: Phase 4
Study type: Interventional

Transcatheter aortic valve implantation (TAVI) is a rapidly growing treatment option for patients with aortic valve stenosis. Stroke is a feared complication of TAVI, with an incidence of around 4-5% in the first 30 days. Up to 50% of patients undergoing TAVI have an indication for oral anticoagulants (OAC) mostly for atrial fibrillation. OAC use during TAVI could increase bleeding complications, but interruption during TAVI may increase the risk for thromboembolic events (i.e. stroke, systemic embolism, myocardial infarction). Recent observational data suggest that periprocedural continuation of OAC is safe and might decrease the risk of stroke. Beside the potential reduction of thromboembolic events, continuation of OAC is associated with an evident clinical ancillary benefit for patients and staff. Since periprocedural OAC interruption not infrequently leads to misunderstanding and potentially dangerous situations, when patients are not properly informed before hospital admission or may experience difficulties with the interruption regimen. Hypothesis: Periprocedural continuation of oral anticoagulants is safe and might decrease thromboembolic complications without an increase in bleeding complications at 30 days

NCT ID: NCT04417829 Completed - Hypertension Clinical Trials

Transcatheter Aortic Valve Implantation in Western NORway

TAVI-NOR
Start date: January 2012
Phase:
Study type: Observational [Patient Registry]

A prospective study of 600 patients with severe aortic stenosis (AS) and symptoms who underwent TAVI at the Haukeland university hospital, Bergen, Norway.

NCT ID: NCT04400513 Completed - Clinical trials for Aortic Valve Stenosis

Development of an Algorithm to Differentiate Heart Murmurs Using Electronic Stethoscopes

Start date: June 25, 2020
Phase:
Study type: Observational

The Eko CORE and DUO stethoscopes are FDA-approved electronic devices that have the capacity to record heart sounds. The study seeks to expand murmur detection to include VHD classification through the development of novel ML algorithms that are able to distinguish between systolic vs. diastolic vs. continuous murmurs, as well as classify VHD type and severity, using 4-point auscultation with Eko CORE and DUO electronic stethoscopes to record heart sounds.

NCT ID: NCT04385459 Completed - Clinical trials for Coronary Artery Disease

Severe Aortic Valve Stenosis and Concomitant Coronary Artery Disease in Patients Undergoing TAVI

Start date: December 13, 2018
Phase:
Study type: Observational

Patients undergoing surgical aortic valve replacement (sAVR) with concomitant coronary artery disease (CAD) are known to have higher mortality rates compared to patients without CAD. This same phenomenom has not been clearly mapped in patients with CAD that goes through a transcatheter aortic valve implantation procedure.