Oxford - Fibrates in Aortic Stenosis
Aortic Valve StenosisAortic 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.
18-F Sodium Fluoride (18F-NaF) PET for the Assessment of Bioprosthetic Aortic Valve Durability and...
Aortic StenosisThis is a pilot study in which we will aim to demonstrate successful execution of the imaging protocol and to make observations regarding the calcification activity as measured by 18F-NaF PET/CT and any correlation to 1) valve age and valve type, and 2) subsequent degeneration of aortic valve bioprostheses based upon clinical, echocardiographic and CT parameters. Additionally, the data will serve as preliminary data to plan a larger study to investigate study objectives.
VALVOSOFT® Pivotal Study
Aortic Valve CalcificationAortic Valve StenosisThe 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
The PROTEMBO Trial
Severe Aortic Valve StenosisThe goal of this prospective, multi-center, randomized, controlled study is to compare the safety and efficacy of the ProtEmbo Cerebral Embolic Protection device to a hybrid control (no embolic protection device ('No Device') and the Sentinel device) in subjects with severe symptomatic native aortic valve stenosis indicated undergoing a TAVR procedure.
Folic Acid Supplementation in Calcific Aortic Valve Disease
Calcification of Aortic ValveAortic Valve StenosisThis is a prospective, randomized, comparative, clinical trial conducted by Wuhan Union Hospital that aims to evaluate the efficacy and safety of folic acid compared to placebo in patients with calcific aortic valve disease with mild aortic valve stenosis.
Routine Versus Selective Protamine Administration to Reduce Bleeding Complications After Transcatheter...
Aortic Valve StenosisHeparin reversal by protamine administration after transcatheter aortic valve implantation (TAVI) may reduce bleeding events. However, protamine can also cause life-threatening allergic reactions. High-quality evidence regarding the clinical safety and efficacy of routine protamine administration after TAVI is lacking. The aim of this clinical trial is to determine if routine protamine administration, compared with selective protamine administration, reduces the risk of cardiovascular mortality or bleeding within 30 days after transcatheter aortic valve implantation.
Effects of Pioglitazone in Calcific Aortic Valve Disease
Calcification of Aortic ValveAortic Valve StenosisThis is a prospective, randomized, comparative, clinical trial conducted by Wuhan Union Hospital that aims to evaluate the efficacy and safety of pioglitazone compared to placebo in patients with calcific aortic valve disease with mild aortic valve stenosis.
Evaluation of Safety and Effectiveness of the EMBLOK EPS During TAVR
Aortic Valve StenosisAortic Valve Disease2 moreThe objective of the study is to evaluate the safety, effectiveness, and performance of the EMBLOK EPS during TAVR by randomized comparison with a commercially available embolic protection device. The targeted study population consists of patients meeting FDA-approved indications for TAVR with commercially available transcatheter heart valve systems. This prospective, multicenter, single-blind, randomized controlled trial will enroll up to a total of 532 subjects undergoing TAVR at up to 30 investigational sites in the United States. All subjects will undergo clinical follow-up (including detailed neurological assessments) in-hospital and at 30 days.
POLESTAR Trial - An International Multi-center Early Discharge TAVI Program
Aortic Valve StenosisAn international multi-center prospective observational study to address safety and feasibility of an early discharge protocol in patients with symptomatic severe aortic stenosis who are eligible for transfemoral TAVI with the Boston Scientific ACURATE Neo Aortic Bioprosthesis transcatheter heart valve.
CT-evaluation of Coronary Ostia Height After Surgical Aortic Valve Replacement.
Heart Valve DiseasesAortic Valve Stenosis11 moreThe goal of this interventional, single-center study is to demonstrate if there is a change in the coronary ostia height after surgical aortic valve replacement and if it depends on the type of prosthesis or surgical technique used. The study involves patients undergoing elective surgical aortic valve replacement with a bioprosthesis. Participants enrolled will undergo a CT scan before and after surgery (at least 90 days after surgery) to analyze coronary ostia height.