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Constriction, Pathologic clinical trials

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NCT ID: NCT03617406 Completed - Clinical trials for Aortic Valve Stenosis

Volume Challenge Added to DSE in the Diagnosis of Severe LFLGAS

FLOW-AS
Start date: May 31, 2018
Phase: N/A
Study type: Interventional

The aim of this study is to test the diagnostic added value of Volume Challenge (VC) to low-dose dobutamine stress echocardiography (LDDSE) in patients with a low-flow, low-gradient aortic stenosis (LFLGAS). This study will assess if LDDSE plus VC allows to increase the proportion of patients in whom a true severe AS can be differentiated from a pseudo severe AS.

NCT ID: NCT03610737 Active, not recruiting - Clinical trials for Spinal Stenosis, Lumbar Region, With Neurogenic Claudication

The MOTION Study - Treatment of LSS With the MILD Procedure

Start date: August 2, 2018
Phase: N/A
Study type: Interventional

Prospective, multicenter, randomized controlled clinical study examining functional improvement in lumbar spinal stenosis (LSS) patients with neurogenic claudication who are treated with the MILD procedure plus conventional medical management (CMM) compared to those treated with CMM alone, as the control. Subjects in the control group are able to crossover and receive MILD after completion of 12-month follow-up. The study will provide objective functional improvement data for patients treated with the mild Procedure as first-line therapy in a real-world setting.

NCT ID: NCT03600051 Completed - Aortic Stenosis Clinical Trials

Automated Phonocardiography Analysis in Adults

Start date: December 10, 2015
Phase:
Study type: Observational

Background: Computer aided auscultation in the differentiation of pathologic (AHA class I) from no- or innocent murmurs (AHA class III) via artificial intelligence algorithms could be a useful tool to assist healthcare providers in identifying pathological heart murmurs and may avoid unnecessary referrals to medical specialists. Objective: Assess the quality of the artificial intelligence (AI) algorithm that autonomously detects and classifies heart murmurs as either pathologic (AHA class I) or as no- or innocent (AHA class III). Hypothesis: The algorithm used in this study is able to analyze and identify pathologic heart murmurs (AHA class I) in an adult population with valve defects with a similar sensitivity compared to medical specialist. Methods: Each patient is auscultated and diagnosed independently by a medical specialist by means of standard auscultation. Auscultation findings are verified via gold-standard echocardiogram diagnosis. For each patient, a phonocardiogram (PCG) - a digital recording of the heart sounds - is acquired. The recordings are later analyzed using the AI algorithm. The algorithm results are compared to the findings of the medical professionals as well as to the echocardiogram findings.

NCT ID: NCT03588455 Completed - Coronary Stenosis Clinical Trials

Pronostic Impact of Flow Fraction Reserve on Intermediate Stenoses

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

The intermediate coronary stenoses defined by a degree of stenosis from 40 to 70 % are frequent. The Flow Fraction Reserve (FFR), realized during coronarography, is an hemodynamic evaluation by the functional impact measuring the loss of load in upstream / approval of the stenosis inthe basal state and in situation of hyperemia led by adenosine. Further to the study FAME, the threshold of definition of the significant character of one Stenosis was fixed for a value of FFR = 0,80. However, the impact forecasts intermediate values badly known rest. We hypothetized that coronary stenosis associated with borderline values of FFR 0.81-0.85 were associated with a higher rate of clinical events than those with a FFR >0.85

NCT ID: NCT03585933 Active, not recruiting - Clinical trials for Aortic Stenosis, Calcific

Prognostic Value of Myocardial Fibrosis in Severe Aortic Valve Stenosis

FIB-AS
Start date: May 8, 2019
Phase:
Study type: Observational

Degenerative aortic valve stenosis (AS) is the most common valve heart disease in the developed Western countries. The hemodynamic progression of AS occurs over time and leads to LV hypertrophy (LVH) as a compensation mechanism of the heart. Morphological changes such as increasing muscle fibre thickness, collagen volume, and interstitial fibrosis occur in AS patients. These changes result in left ventricular (LV) diastolic and systolic dysfunction and, consequently, to with AS related symptoms. When symptoms associated with AS appear, patients' prognosis is poor if surgical aortic valve replacement (SAVR) or a trans-catheter aortic valve implantation (TAVI) is not performed. Primary hypothesis of the research: fibrotic changes in the myocardium are related to immediate (in hospital) or long-term complications (MACE and all-cause mortality) in patients with severe AS. The goal of the study is to determine the prognostic implications of focal as well as diffuse myocardial fibrosis in patients with severe aortic valve stenosis.

NCT ID: NCT03584074 Not yet recruiting - Clinical trials for Spinal Stenosis Lumbar

Clinical Trial of Pregabalin and COX2 in Spinal Stenosis

Start date: July 1, 2018
Phase: Phase 4
Study type: Interventional

Aim of this prospective, single-blind, randomized study was to compare the efficacy of the combination of celecoxib and pregabalin and celecoxib only monotherapy for treatment of chronic low-back pain.

NCT ID: NCT03572348 Completed - Surgery Clinical Trials

VeSpAR: Comparing Vessel-Sparing Anastomotic Repair and Transecting Anastomotic Repair in Isolated Short Bulbar Strictures.

VeSpAR
Start date: September 26, 2018
Phase: N/A
Study type: Interventional

The investigators want to verify whether the surgical outcome of vessel-sparing anastomotic repair in isolated short bulbar urethral strictures is not inferior to the surgical outcome of transecting anastomotic repair. Furthermore, the investigators compare the functional outcome of both techniques verifying if there is less erectile dysfunction after vessel-sparing anastomotic repair than after transecting anastomotic repair.

NCT ID: NCT03570801 Terminated - Clinical trials for Lumbar Spinal Stenosis

SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion

SLIPII
Start date: October 17, 2017
Phase: N/A
Study type: Interventional

The purpose of the project is to perform an RCT comparing patient satisfaction and outcome with or without the use of an expert panel. The purpose is also to create a registry to compare the effectiveness of decompression alone versus decompression with fusion for patients with degenerative grade I spondylolisthesis and symptomatic lumbar spinal stenosis. Primary analysis will focus on the patients' improvement from baseline patient-reported outcome questionnaires. In addition, the SLIP II registry aims to (i) develop an algorithm which could identify cases in which surgical experts are likely to recommend one treatment (i.e. >80% of experts recommend one form of treatment) and (ii) develop a radiology-based machine learning algorithm that would prospectively classify patients as either 'stable' or 'unstable.' In addition to patient reported outcomes, step counts will be collected in order to determine the correlation of step count with patient-reported outcomes (ODI and EQ-5D) and the need for re-operation. This registry portion of the study aims to prospectively collect comparative data for these patients treated with either decompression alone or decompression with fusion.

NCT ID: NCT03570190 Completed - Clinical trials for Aortic Valve Stenosis

Registry to Evaluate the Impact of a Valve Coordinator on Aortic Stenosis / TAVI Outcome - (German Pilot)

Coordinate
Start date: December 20, 2018
Phase:
Study type: Observational [Patient Registry]

Prospective, multicenter registry in patients undergoing commercially available balloon expandable valve implantation. The registry will consist of 3 phases: Prospective determination of baseline Status Quo (3 months): Documentation of treatment pathways and endpoints of "routine" patients without educational program Dedicated reflection and training (1 day): One training session after the observational period to reflect on treatment pathways, exchange between valve coordinators involved, and develop improvements. Implementation of tailored changes (2 months): Implementation of the changes developed in the training. Determination of the effect (3 months): Coordinator measures optimization changes and determines effects.

NCT ID: NCT03567278 Completed - Clinical trials for Aortic Stenosis Symptomatic

Feasibility Trial on ACURATE™ Transapical Implantation in Patients With Severe Symptomatic Aortic Stenosis (2009-01)

TA-FIM
Start date: November 2009
Phase: N/A
Study type: Interventional

Feasibility Trial on the ACURATE TA™ transapical implantation in patients presenting severe symptomatic aortic stenosis to collect human feasibility data pertaining to the safety and performance of the device.