Clinical Evaluation of MDT-2111 in Subjects With Small Aortic Annuli and Symptomatic Severe Aortic...
Aortic Valve StenosisThe primary objective of the present trial is to demonstrate the safety and effectiveness of the MDT-2111 in the treatment of symptomatic severe aortic stenosis in subjects with small aortic annuli and deemed difficult for surgical operation.
Freedom SOLO Stentless Heart Valve Study
Aortic StenosisAortic InsufficiencyThe purpose of this clinical investigation is to demonstrate the safety and effectiveness of the Freedom SOLO heart valve.
Glutamate and Diastolic Function in Patients Undergoing Aortic Valve Repair
HypertrophyLeft Ventricular3 morePurpose: The effect of intravenous glutamate infusion on myocardial diastolic function and overall hemodynamics were studied in patients undergoing elective aortic valve replacement with severe aortic stenosis and associated left ventricular hypertrophy . Methods: 25 patients will be included in this double-blind randomized placebo-controlled study. Glutamate was administered intravenously immediately after aortic cross-clamp release. The patients receive either a low dose of 30mg kg-1 h-1 (LG-group) or high dose of 60 mg kg-1 h-1 (HG-group) or placebo (P-group) at a rate of 3.3ml kg-1h-1 for 2h. Transesophageal echocardiography (TEE) is used to measure diastolic and systolic ventricular function before sternotomy (T0), and 2h (T2), 3h (T3) and 6h (T4) after release of cross clamp. Additionally routine hemodynamic parameters are measured intraoperatively.
Effects of Rosuvastatin on Aortic Stenosis Progression
Aortic StenosisThe purpose of this study is to assess the effects of rosuvastatin compared to usual care in patients diagnosed with aortic valvular stenosis. Patients must have a diagnosis of mild to moderate aortic stenosis (AS) and no clinical indication for the use of cholesterol lowering agents. A multi-centre, randomized, double-blind, placebo-controlled study, with a two year recruitment period, and a treatment duration of a minimum of 3 years from the time of the last patient randomized to a maximum of 5 years.
Single Perclose Escalation Technique for Vascular Closure in TAVR
Aortic Valve StenosisStructural Valve Deterioration1 moreThis study examines in the safety and efficacy of using a single Perclose escalation technique (SPET) using a single Perclose Proglide device to preclose and the need for a rescue device based on a control angiography at the end of the procedure, with a 6F femoral sheath.
The Use of ACURATE Neo 2 Valve in Patients With Symptomatic Aortic Valve Stenosis
Severe Aortic Valve StenosisThe objective of this study is to evaluate the ACURATE Neo2 in the Middle East population with severe, symptomatic aortic stenosis.
HEParin Antagonisation in Transcatheter Aortic Valve Implantation
Aortic Valve StenosisTranscatheter Aortic Valve Implantation1 moreUnfractioned heparin is usually given in a defined dosage during transfemoral TAVI. Activated Clotting Time (ACT) is usually used to measure the heparin effect. ACT-analysis is easy to perform at the bedside, but susceptible to interference effects. At the end of the procedure, protamine is given to reverse eventual residual heparin effect. An overdose of protamine can impair the coagulation itself. The investigators want to analyse the effect of a partial heparin reversal by ROTEM Analysis.
Pacing the Atrium to Confirm or Exclude Pacemaker Indication in TAVI
Aortic Valve StenosisThe current observational registry aims to evaluate in patients undergoing TAVI implantation: the positive and negative predictive value for PPM post TAVI of Wenckebach phenomenona (WB) during RAP during the TAVI procedure, baseline and procedural characteristics of TAVI-implantation associated with new conduction abnormalities and need for PPM implantation, peri-procedural safety, in-hospital and 1-month outcomes after TAVI implantation.
Patient Reported Health-Related Quality of Life After Limited Access and Conventional Aortic Valve...
Aortic Valve StenosisLimited Access Aortic Valve Replacement1 moreThe LIAR-Trial is a single-center, single blind randomized controlled clinical trial comparing patients undergoing isolated AVR via J-shaped upper hemi-sternotomy (UHS) and conventional AVR through a full median sternotomy (FMS). Primary outcome is cardiac-specific quality of life, measured by two domains of the Kansas City Cardiomyopathy Questionnaire (KCCQ), up to one year after surgery.
Transcaval Access for Transcatheter Aortic Valve Replacement in People With No Good Options for...
Aortic Valve StenosisBackground: - Some people who need a transcatheter aortic valve replacement (TAVR) have leg arteries that are too small and are too sick for standard techniques. But they may benefit from a new technique called transcaval TAVR. For this technique, doctors make a hole between the largest vein (vena cava) and largest artery (aorta) in the body, inside the abdomen. Then they replace the valve through a tube they put in the groin vein. Then they close the hole between the vein and the artery using a device designed to close holes in the heart. This study tests the device for this new, off-label use. Objective: - To further study the safety and effectiveness of transcaval TAVR. Eligibility: - Adults age 21 and older who would benefit from TAVR but for whom standard techniques are not suitable. Design: Participants will be selected by a team of heart specialists and others. Participants will have a computed tomography (CT) scan with or without contrast dye. Participants will have blood tests. Participants will have transcaval TAVR. Participants will receive the same standard care as for all patients with TAVR. Participants will also have another CT scan, or an MRI or ultrasound, before they leave the hospital, and again after about 30 days and after about 12 months. Participants will be contacted 1 and 6 months afterwards and will have another visit 1 year later. They will have a CT, MRI, or ultrasound. They will have blood tests and a physical exam.