Active clinical trials for "Aortic Valve Stenosis"

The aim of this trial is to evaluate the safety and cost effectiveness of omission of percutaneous coronary intervention of significant coronary artery disease in patients scheduled to undergo transcatheter aortic valve implantation.

Calcific Aortic Stenosis (CAS) can cause severe adverse cardiac events, but there is currently no effective drug that can prevent or delay the progression of the disease, aortic valve replacement is still the only therapy. The epidemiology of CAS shows that it is related with level of Lp(a)、LDL-C and PCSK9. Several observational studies indicate that the use of statins to decrease the level of LDL-C is associated with the reduced incidence of CAS, but no Randomized Control Trials(RCTs) show that statins have any benefit on the progression or clinical outcome of CAS，so the investigators speculated that this may be related to the limited reduction of LDL-C by statins therapy. The proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor has emerged as a new lipid-lowing drug. On the basis of statin treatment, it can further reduces LDL-C and Lp(a) concentrations by 50% to 60% and 20% to 30%,respectively. Some studies report that elevated plasma PCSK9 levels are related to CAS and PCSK9 R46L loss-of-function mutation are associated with lower rates of CAS, and other observational studies found that PCSK9 inhibitors can reduce the incidence of CAS. The research, on the basis of statins therapy, intends to study the effect of PCSK9 inhibitors on delaying or preventing patients with CAS. A total of 160 patients are planned to be selected for the presence of CAS that are confirmed by echocardiography but currently do not need valve replacement, and with the diagnosis of hypercholesterolemia. All of the patients were followed at 4 weeks、24 weeks 、48 weeks and 96 weeks for a minimum of 2 years. The primary endpoint is the average annual change in aortic-jet velocity. Secondary endpoints include average annual change of aortic valve calcification score that measured by Computed Tomography and major adverse cardiovascular events (cardiovascular death, non-fatal stroke or non-fatal myocardial infarction). The outcomes of the study will provide new ideas for the treatment of patients with CAS, and will also provide an important theoretical basis for the expansion of the clinical indications of PCSK9 inhibitors and the exploration their extra-lipid-lowering effects.

To Evaluate the Safety and Effectiveness of Transcatheter Aortic Valve System ( Chengdu Silara Medtech Inc. ,Chengdu, China)in Patients with Severe Aortic Stenosis with or without Moderate or Lower Degree Regurgitation

This study is intended to investigate the effect of angiotensin receptor blockers (ARBs) on mild-to-moderate aortic stenosis.

The aim of the present study is to investigate safety and efficacy of early versus deferred aortic valve replacement in patients with moderate aortic stenosis combined with moderate mitral regurgitation.

The optimal pharmacological therapy after transcatheter aortic valve implantation (TAVI) to prevent valve thrombosis and reduce thromboembolic complications without significantly increasing the risk of bleeding is not yet fully defined and constitutes an important unmet clinical need. Recently, single antiplatelet therapy (SAPT) with Aspirin has been increasingly adopted to avoid bleeding early after TAVI compared with dual antiplatelet therapy. However, TAVI population is affected by a diversity of chronic pathologies that increase the risk of post-TAVI ischemic complications. Stroke is prevalent, especially peri- and early post-TAVI (<1-8% in the 1st year). Although peri-TAVI myocardial infarction (MI) is rare (1-3%), concomitant coronary artery disease (CAD), diabetes mellitus (DM), and peripheral vascular disease (PVD), is very frequent in the TAVI population, affecting around 30-70% of patients. In patients with CAD, the need to re-access the coronary arteries after TAVI is challenging and can be hampered by the trancatheter valve struts. This is critical in TAVI patients with an acute coronary syndrome and in younger patients with long-life expectancy after TAVI. The use of a P2Y12 inhibitor provides significant ischemic protection in the in the coronary, cerebral and peripheral vascular territories compare to Aspirin. The use of a P2Y12 inhibitor as antiplatelet treatment can decrease the need for new coronary revascularizations and reduce the incidence of thromboembolic complications after TAVI.

Rationale: Patients undergoing cardiac surgery are at risk of developing perioperative complications and major adverse cardiac events, mainly related to both their preoperative status and type of surgical procedure. Postoperative exercise based cardiac rehabilitation (CR) is an effective therapy to prolong survival and improve quality of life. However, little is known about the effect on post-operative complications, quality of life and return to work of a combined pre- and post-operative CR program encompassing physical therapy, dietary counseling, psychological support and life style management compared to a CR program, which is provided only after cardiac surgery. Objective: to determine whether a pre- and postoperative (PRE+POST) CR program improves the short (up to three months) and long term outcomes (up to one year) of the cardiac surgery (i.e. reduction in postoperative surgical complications, readmissions to hospital and major adverse cardiac events in conjunction with improvements in the physical component of health related quality of life), when compared to postoperative CR only (POST). Study design: A Prospective Randomized Open controlled trial, Blinded End-point. Patients are randomized between two standard care CR programs. One group will start a the POST CR program after surgery. The other group will be randomized to a combined PRE+POST CR program. Study population: Patients (age > 18 years) admitted for elective coronary bypass surgery, valve surgery and/or aortic surgery Main study parameters/endpoints: The primary outcome is a composite weighted endpoint of postoperative surgical complications, re-admissions to hospital, major adverse cardiac events and health related quality of life (two domains: physical functioning and physical problem), at three months and one year after surgery. Endpoints are determined by an independent endpoint committee, blinded to the group allocation. Secondary, the study focuses on physical health (cardiorespiratory fitness, muscle strength and functional status), psychological health (feelings of anxiety and depression), work participation, economics, lifestyle risk factors (physical activity and smoking behavior), self-efficacy and illness representations.

The primary hypothesis of the proposed study is that an electrophysiology-based algorithmic approach is superior to standard clinical follow-up with 30-day monitoring in reducing the combined endpoint of syncope, hospitalization, and death in patients in patients with new of left bundle branch block following transcatheter aortic valve implantation (TAVI).

The primary objective of this study (LANDMARK) is to compare the safety and effectiveness of the Myval THV Series with Contemporary Valves (Sapien THV Series and Evolut THV Series) in patients with severe symptomatic native aortic valve stenosis. This study will be done in total 768 subjects (384:384, Myval THV Series vs. Contemporary Valves) The randomisation will be carried out with an allocation ratio of 1:1 between Myval THV Series vs. Contemporary Valves (Sapien THV Series and Evolut THV Series)

Recent evidence from scientific literature supported the extension of TAVI procedures to lower risk populations. Despite its widespread usage, the expansion of TAVI into lower risk patient populations is still limited by complications and costs, with a large disparity between clinical trials and real-world scenarios suggesting still long hospitalizations after TAVI. This issue has got relevant implications in cost-effectiveness of the procedure, with many studies showing a more favourable cost profile associated with early discharges