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Constriction, Pathologic clinical trials

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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: NCT03562936 Active, not recruiting - Clinical trials for Degenerative Spondylolisthesis

The NORDSTEN Studies/The Observational Cohort Study

NORDSTEN/OS
Start date: February 2014
Phase:
Study type: Observational

The NORDSTEN- OS(Observational study) aim to study the natural course in patients with mild to moderate symptomatic lumbar spinal stenosis with and without degenerative spondylolisthesis. 10 years follow-up is planned. The NORDSTEN-OS is one of three studies in The NORwegian Degenerative Spondylolisthesis and Spinal STENosis studies. The two other studies are: NORDSTEN-SST (Spinal stenosis trial) (NCT02007083); a randomized controlled trial comparing the clinical and radiological results in three different decompression techniques in patients with lumbar spinal stenosis. The NORDSTEN-DS (Degenerative spondylolisthesis) (NCT02051374); a randomized controlled trial comparing the outcome of surgery with decompression without fixation and decompression with fixation in patients with lumbar spinal stenosis and concurrent degenerative spondylolisthesis.

NCT ID: NCT03517436 Active, not recruiting - Clinical trials for Aortic Valve Stenosis

ExCEED: CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis

Start date: September 18, 2018
Phase: N/A
Study type: Interventional

This study will monitor the safety and valve performance of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe, calcific aortic stenosis who are at intermediate operative risk for surgical aortic valve replacement (SAVR).

NCT ID: NCT03499964 Active, not recruiting - Urethral Stricture Clinical Trials

ROBUST III- Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease

ROBUST-III
Start date: June 22, 2018
Phase: N/A
Study type: Interventional

ROBUST III is a prospective, multi-center, randomized controlled adaptive sample size clinical trial to establish the safety and effectiveness for the Optilume Stricture Drug Coated Balloon (DCB).

NCT ID: NCT03471065 Active, not recruiting - Clinical trials for Aortic Valve Stenosis

The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic, Severe Aortic Stenosis

Start date: June 1, 2018
Phase: N/A
Study type: Interventional

This study will confirm the procedural safety and performance of the SAPIEN 3 Ultra System in subjects with severe, calcific AS who are at intermediate operative risk for standard aortic valve replacement.

NCT ID: NCT03466918 Active, not recruiting - Aortic Stenosis Clinical Trials

China S3: Safety and Effectiveness of Edwards Lifesciences SAPIEN 3 THV in the Chinese Population

Start date: May 23, 2018
Phase: N/A
Study type: Interventional

To evaluate the safety and effectiveness of the SAPIEN 3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve implantation (TAVI) in Chinese patients with symptomatic severe calcific aortic stenosis who are considered at high risk for surgical valve replacement.

NCT ID: NCT03424941 Active, not recruiting - Aortic Stenosis Clinical Trials

The TransCatheter Valve and Vessels Trial

TCW
Start date: May 31, 2018
Phase: N/A
Study type: Interventional

The trial objective is to investigate whether Fractional Flow Reserve (FFR)-Guided Percutaneous Coronary Intervention (PCI) and TransCatheter Aortic Valve Implantation (TAVI) strategy for treatment of multivessel disease and aortic stenosis will be non-inferior to Coronary Artery By-pass Grafting (CABG) and Surgical Aortic Valve Replacement (SAVR) for a composite primary endpoint of all-cause mortality, stroke, myocardial infarction, coronary or valve re-intervention and life-threatening or disabling bleeding at one year.

NCT ID: NCT03411317 Active, not recruiting - Clinical trials for Aortic Valve Stenosis

Aortic Stenosis: Determinants of Progression, Severity and Left Ventricular Remodeling

AS-PROGRESSION
Start date: December 11, 2017
Phase:
Study type: Observational

Aortic stenosis (AS) is the most frequent valvulopathy in Western countries. The prevalence of AS is constantly increasing due to the aging of the population. Although significant progress has been made in understanding the pathophysiological mechanisms underlying the onset and progression of AS, there is no medical treatment to slow or prevent its progression. The only treatment available is Aortic Valve Replacement (AVR) performed by surgery or by catheterization (TAVI). AS is associated with an increase of post-load which leads the left ventricular myocardium to hypertrophy. Associated with hypertrophy, myocardial fibrosis will gradually develop. Despite interesting data, many unknowns persist and remain to be identified. The aim of the study is to evaluate prospectively the progression and impact of AS in 500 patients using clinical, biological, echocardiographic and MRI parameters performed annually.

NCT ID: NCT03411304 Active, not recruiting - Clinical trials for Aortic Valve Stenosis

Aortic Stenosis: Determinants and Prognostic Value of Preoperative Left Ventricular Remodeling After Valvular Replacement

Start date: December 5, 2017
Phase:
Study type: Observational

Aortic stenosis (AS) is the most frequent valvulopathy in Western countries. The prevalence of AS is constantly increasing due to the aging of the population. Although significant progress has been made in understanding the pathophysiological mechanisms underlying the onset and progression of AS, there is no medical treatment to slow or prevent its progression. The only treatment available is Aortic Valve Replacement (AVR) performed by surgery or by catheterization (TAVI). AS is associated with an increase of post-load which leads the left ventricular myocardium to hypertrophy. Associated with hypertrophy, myocardial fibrosis will gradually develop. Despite interesting data, many unknowns persist and remain to be identified. The aim of the study is to characterize prospectively the left ventricular remodeling and assess its changes after AVR and within 1 year in 500 patients using clinical, biological, echocardiographic and MRI parameters.

NCT ID: NCT03383445 Active, not recruiting - Aortic Stenosis Clinical Trials

Transcatheter Aortic Valve Replacement Versu Surgical Aortix Valve Replacement for Treating Elderly Patients With Severe Aortic Stenosis and Small Aortic Annuli: A Prospective Randomized Study The VIVA Trial

Start date: August 8, 2017
Phase: N/A
Study type: Interventional

To date, no formal, randomized, prospective, head-to-head comparisons of surgical aortic valve replacement (SAVR) versus transcatheter aortic valve replacement (TAVR) have been undertaken in the severe aortic stenosis (AS) population with small aortic annuli. Objectives of the present study are to compare the hemodynamic performance (incidence of severe PPM and ≥ moderate AR) and clinical outcomes (death, stroke, major or life threatening bleeding) between TAVR and SAVR in patients with severe AS and small aortic annuli.