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Constriction, Pathologic clinical trials

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NCT ID: NCT05696470 Active, not recruiting - Radiculopathy Clinical Trials

Fusion Rates of 3D Printed Porous Titanium Cages in Three and Four Level ACDFs

Start date: March 31, 2021
Phase:
Study type: Observational [Patient Registry]

The purpose of this trial is to assess fusion rates in 3 and 4 level ACDFs in patients implanted with DePuy Conduit 3D printed titanium cages supplemented with SKYLINE Anterior Cervical Plate System and 1 CC DBM. This will be a non-inferiority study, looking to show that Synthes Conduit 3D printed titanium cages fuse as well as cages.

NCT ID: NCT05539573 Active, not recruiting - Aortic Stenosis Clinical Trials

PROVE ACURATE neo2™ - Post Market Safety and Performance Surveillance in Aortic Stenosis

PROVE
Start date: October 4, 2022
Phase:
Study type: Observational [Patient Registry]

Aortic valve sclerosis (aortic valve thickening and calcification without pressure gradient) is one of the most common valvular abnormalities in the Western world. Per year, about 1.8-1.9% of these patients develop aortic valve stenosis which will eventually be treated by TAVI (Transcatheter aortic valve implantation). The purpose of this study is to collect and monitor ongoing safety and performance clinical data of the ACURATE neo2™ aortic bioprosthesis and the ACURATE neo2™ transfemoral delivery system, hereafter referred to as the ACURATE neo2™ and transfemoral delivery system in the context of an observational investigator initiated trial (IIT).

NCT ID: NCT05478161 Active, not recruiting - Clinical trials for Transcatheter Aortic Valve Implantation

Investigation of the ALLEGRA THV System With a New Delivery System in Patients With Aortic Stenosis or Failed Surgical Bioprosthesis

EMPIRE
Start date: January 24, 2023
Phase: N/A
Study type: Interventional

The EMPIRE study confirms the technical performance of the new IMPERIA Delivery System and evaluates the safety and efficacy of the entire ALLEGRA THV System. The primary endpoint is device success rate at 7 days (discharge from index procedure or 7 days post implant, whichever comes first), as defined by VARC 2. Based on the outcomes of a study with a similar device and considering a drop-out rate of 5%, 107 patients need to be enrolled in the study.

NCT ID: NCT05309447 Active, not recruiting - Clinical trials for Lumbar Spinal Stenosis

Effect of Muscle Fatigue on Spinal Imbalance and Motion in Lumbar Spinal Stenosis

MuscLSS
Start date: November 11, 2021
Phase:
Study type: Observational

This study assesses spinal imbalance and motion in patients with sLSS and elicits fatigue via back exercises and compares spinal imbalance and motion before and after the fatigue exercise and compares these to healthy controls, allowing to associate sLSS-specific motion patterns to paraspinal muscle fatigue.

NCT ID: NCT05273879 Active, not recruiting - Clinical trials for Lumbar Spinal Stenosis

Necessity of Fusion Following Decompression Surgery in Patients With Single-level Lumbar Stenosis

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

Long-term clinical results of two methods of surgical treatment (spinal decompression with or without fusion) in patients with single-level lumbar stenosis will be compared. A clear framework for surgical treatment methods and standardized postoperative rehabilitation treatment will be set to obtain the maximum homogeneity of the patient groups. This trial should provide the first level of evidence for the need for spinal fusion in patients with single-level lumbar stenosis, subject to the high homogeneous comparison groups. Additional results will allow comparing the economic aspects of different surgical treatments for 2 years after surgery.

NCT ID: NCT05256758 Active, not recruiting - Clinical trials for Aortic Valve Stenosis

Oxford - Fibrates in Aortic Stenosis

OxFAST
Start date: May 29, 2019
Phase: N/A
Study type: Interventional

Aortic stenosis (AS) is characterised by left ventricular (LV) hypertrophy and altered myocardial substrate metabolism. Peroxisome proliferator-activated receptor (PPARα), a regulator of lipid metabolism is deactivated in pressure overload hypertrophy such as in AS and can lead to dysregulation of fatty acid oxidation, myocardial triglyceride accumulation (steatosis) and lipotoxicity. The investigators propose a proof-of-concept study to investigate the effect of altering myocardial triglyceride (MTG) using a PPARα agonist, fenofibrate on cardiac physiology in patients with asymptomatic moderate-severe AS. The primary endpoint is a change in MTG assessed by magnetic resonance spectroscopy at baseline and after 6 months of treatment. Exploratory endpoints are changes in cardiac physiology including myocardial deformation (strain) as assessed by cardiac magnetic resonance imaging. The investigators hypothesise that pharmacological reduction of MTG with a PPARα agonist will result in steatosis regression and changes in cardiac physiology.

NCT ID: NCT05252351 Active, not recruiting - Clinical trials for Congenital Aortic Stenosis

Cardiac Imaging in Adults With Congenital Aortic Stenosis

CAS
Start date: January 13, 2022
Phase:
Study type: Observational

The CAS study is a prospective observational cohort study investigating the effects of congenital aortic stenosis (ConAoS) on the left ventricular function and the prevalence, pattern and expanse of left ventricular hypertrophy (LVH), myocardial stiffness and myocardial fibrosis.

NCT ID: NCT05242497 Active, not recruiting - Clinical trials for Lumbar Spinal Stenosis

Effectiveness and Safety of Pharmacopuncture Therapy for Patients With Lumbar Spinal Stenosis

Start date: April 13, 2022
Phase: N/A
Study type: Interventional

This is 1:1 pragmatic randomized controlled trials in a parallel-grouped, multi-centered design that investigated pharmacopuncture therapy for patients with lumbar spinal stenosis, compared to the conservative treatments including physiotherapy and pharmacological treatments.

NCT ID: NCT05235568 Active, not recruiting - Clinical trials for Aortic Valve Stenosis

VALVOSOFT® Pivotal Study

Start date: June 15, 2022
Phase: N/A
Study type: Interventional

The objective of the study is to evaluate the safety and performance of a new non-invasive ultrasound therapy (NIUT) with Valvosoft in the treatment of Calified Aortic Stenosis

NCT ID: NCT05182307 Active, not recruiting - Clinical trials for Symptomatic Aortic Stenosis

DurAVR™ THV System: First-In-Human Study

Start date: November 15, 2021
Phase: N/A
Study type: Interventional

A prospective, non-randomized, single-arm, single-center, first-in-human study designed to evaluate the safety and feasibility of the DurAVR™ THV System in the treatment of subjects with symptomatic severe aortic stenosis.